News

United Healthcare

New Protocol Updates Available For The National Gold Card Program

UnitedHealthcare remains committed to modernizing the prior authorization process and simplifying the health care experience for consumers and health care professionals. Our UnitedHealthcare National Gold Card program is available for provider groups who meet eligibility requirements. The National Gold Card program recognizes qualified practices that have consistently demonstrated adherence to evidence-based guidelines.

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FDA

FDA approves atezolizumab and hyaluronidase-tqjs for subcutaneous injection

  • Kelly Wilson
  • September 12, 2024
  • Drugs
  • No Comments

On September 12, 2024, the Food and Drug Administration approved atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech, Inc.) for subcutaneous injection for all the adult indications as the intravenous formulation of atezolizumab (Tecentriq, Genentech, Inc.), including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), hepatocellular carcinoma (HCC), melanoma, and alveolar soft part sarcoma (ASPS)….

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Prescription for Change: Doctors Cast Their Votes for a Healthier Future

As oncologists, you are at the forefront of our community’s well-being. This election season, your vote can make a significant impact on the future of cancer care. Your daily encounters with patients provide you with a unique perspective on the healthcare system’s strengths and weaknesses. Voting is not just a civic duty; by exercising your…

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Centers for Medicare & Medicaid Services (CMS) Releases the First Ten Drug Prices Negotiated in IRA Process for Part D

The Biden-Harris Administration announced that it has reached agreements for new, lower prices for all 10 drugs selected for negotiations. According to CMS, these negotiated drugs are some of the most expensive and most frequently dispensed drugs in the Medicare program and are used to treat conditions such as heart disease, diabetes, and cancer. The…

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Merit-based Incentive Payment System (MIPS) Automatic Extreme and Uncontrollable Circumstances (EUC) Policy Applied to MIPS Eligible Clinicians in Florida

In response to Hurricane Debby, as identified by both the Health and Human Services (HHS) Public Health Emergency (PHE) declaration (Florida) and Federal Emergency Management Agency (FEMA) disaster declaration (DR-4806-FL), the Centers for Medicare & Medicaid Services (CMS) has determined that the MIPS automatic EUC policy will apply to MIPS eligible clinicians in designated affected…

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2025 Hospital Inpatient Payment Rule Addresses Drug Shortages, Social Determinants of Health, Graduate Medical Education; Finalizes New Payment Model

CMS issued the fiscal year (FY) 2025 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital (LTCH) Prospective Payment System (PPS) final rule. The rule finalizes updates to Medicare fee-for-service payment rates and policies for inpatient hospitals and LTCHs for FY 2025. Key highlights of the final rule include: Standardized Amount, Drug Shortages,…

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ASCO

ASCO Research Statement Details Recommendations To Improve Accessibility Of Cancer Clinical Trials Through Decentralization

Strategies to bring clinical trials closer to patients gained momentum during the COVID-19 pandemic, enabling more participants to receive treatment and/or testing in their local communities. Incorporation of decentralized trial elements presents both opportunities and challenges, spanning regulatory, technical, and operational aspects. This ASCO research statement includes timely consensus-driven recommendations and a call for engagement…

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ASCO

Health Information Exchange Proposal Focuses on Real-Time Benefit Tools, Information Blocking, Interoperability

The Department of Health and Human Service, through the Office of the National Coordinator for Health Information Technology (ONC), released the Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2) proposed rule. The HTI-2 proposal includes new and revised standards and certification criteria for the ONC Health IT Certification Program…

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Governor Signs Legislation Taking First Step to Improving Access to Biomarker Testing for Floridians

Gov. Ron DeSantis signed HB885 into law on June 18th, which expands patient access to biomarker testing, a key tool used by physicians to identify the most effective treatment of cancer and other diseases. In the case of a cancer diagnosis, biomarker testing allows doctors to develop a personalized treatment plan. It opens the door…

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ASCO

Bipartisan, ASCO-Endorsed Prior Authorization Bill Reintroduced in Congress

Bipartisan members of the Unites States House of Representatives and Senate have reintroduced the Association for Clinical Oncology (ASCO)-endorsed Improving Seniors’ Timely Access to Care Act (H.R.8702/S.4532) to streamline prior authorization within Medicare Advantage (MA) plans. The bill currently has 175 combined cosponsors (45 senators and 130 representatives). Last Congress, this legislation unanimously passed in…

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BioSpace

New Cervical Cancer Guidelines Released

The American Society for Colposcopy and Cervical Pathology (ASCCP) is proud to announce a major milestone by the groundbreaking Enduring Guidelines initiative, aimed at revolutionizing the fight against cervical cancer. In a bid to ensure the most current and effective clinical management strategies, the Enduring Guidelines process seeks to integrate emerging technologies and the latest…

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Judge Grants Biden Administration Motion to Dismiss Legal Challenge from PhRMA

On February 11, a federal judge dismissed a drug industry trade group’s legal challenge to halt Medicare drug price negotiations, ruling that it lacked standing. The complaint was filed by the Pharmaceutical Research and Manufacturers of America (PhRMA), the Global Colon Cancer Association (GCCA), and the National Infusion Center Association (NICA) in June of last…

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Session Midpoint Report: What Physicians Should Know

February 14, 2024 marked day 30 of the 60-day Florida Legislative Session, and the FMA remains hard at work to help physicians practice medicine. This midpoint report by FMA Assistant General Counsel Mary Thomas, Esq., summarizes some of the most notable bills that could affect you and your patients, where each one stands in the…

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First Coast Service Options

2024 MEDPARD Available Now!

The 2024 Medicare Participation Physicians / Suppliers Directory (MEDPARD) is now available. As in the past, there will be no hardcopy distributions. Beneficiaries can use the Physician Compare website or contact 1-800-MEDICARE for assistance in locating a participating supplier near their home.

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CMS Releases Guidance for Code G2211

The Centers for Medicare & Medicaid Services (CMS) has released guidance on the billing requirements for G2211 to ensure that coding and billing staff know when to bill the code, the necessary documentation requirements, and the associated patient coinsurance and deductibles. In the 2024 Medicare Physician Fee Schedule Final Rule, CMS finalized coding and reimbursement…

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Congress Passes Bill to Fund Government into March

On Thursday evening, Congress passed another short-term spending bill, funding the federal government into early March. Unfortunately, the bill only extended healthcare-related policies that were included in the previous funding bill and does not include any new healthcare policies, such as an increase in the Medicare Physician Fee Schedule. The previous spending bill funded a…

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NCCN

Olverembatinib Included in Newest Guidelines on Chronic Myeloid Leukemia (CML) Management from the National Comprehensive Cancer Network (NCCN)

  • Kelly Wilson
  • January 17, 2024
  • News
  • No Comments

Ascentage Pharma (6855.HK) announced that olverembatinib (R&D Code: HQP1351) has been included in the latest guidelines from the National Comprehensive Cancer Network (NCCN) for the management of Chronic Myeloid Leukemia (CML),[1] marking a major development in global recognition for its best-in-class drug candidate, which has been approved in China for the management of tyrosine kinase…

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CMS Releases Final Rule on Prior Authorization and Interoperability

On January 17, 2024, the Centers for Medicare and Medicaid Services released the “CMS Interoperability and Prior Authorization final rule (CMS-0057-F).” The rule would place new requirements on Medicare Advantage (MA) organizations, state Medicaid and Children’s Health Insurance Program (CHIP) Fee-for-Service programs, Medicaid managed care plans, CHIP managed care entities, and Qualified Health Plan (QHP)…

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Tell Congress To Eliminate 3.37% Payment Cut

Time is running out for Congress to eliminate a 3.37% Medicare physician payment cut by passing H.R. 6683, the “Preserving Seniors’ Access to Physicians Act.” Please urge your Congress members to support including H.R. 6683 in the 2024 appropriations package by submitting this form letter. Further cuts in Medicare physician pay would undermine access to…

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New Guidance on Medicare Inflation Rebates Adjusts for Drug Shortages

CMS published revised guidance on the Medicare Prescription Drug Inflation Rebate Program. That program was established under the Inflation Reduction Act (IRA), which requires drug companies to pay a rebate to Medicare if they raise their prices for certain drugs faster than the rate of inflation. Specifically, IRA established inflation rebates for single-source drugs and…

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FMA

Is it time to retain your fingerprints?

  • Amanda Bridges
  • December 21, 2023
  • News
  • No Comments

Every physician who applies for licensure in Florida on or after January 1, 2013 must submit to the Department of Health a set of fingerprints as part of the background screening process. Once the fingerprints are submitted, the information is stored in Florida’s Care Provider Background Screening Clearinghouse. The stored fingerprints must be retained by…

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Drug Shortages

  • Amanda Bridges
  • December 11, 2023
  • News
  • No Comments

What’s Happening: The ongoing and, in some cases, worsening shortages of critical oncology drugs are impacting patients and their oncology care team. ASCO is engaging with congressional leaders on both sides of the aisle and in the House and Senate on proposals to mitigate drug shortages. The lack of predictability in the generic cancer drug supply chain can have severely negative impacts on patients with cancer, including disruptions or delays in treatment, potentially leading to irreversible disease progression. Both Congress and the Administration need to intervene to secure the pharmaceutical pipeline and address drug shortages.

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American Cancer Society

CMS Investigative Study to Examine Benefit of Multi-Cancer Early Detection Tests for Medicare Beneficiaries

A Pathway to Coverage Once Tests Show Clinical Benefit a Critical Next Step WASHINGTON, DC – November 20, 2023 – Grail, LLC announced this morning that the Centers for Medicare and Medicaid Services (CMS) and Food and Drug Administration (FDA) approved an Investigational Device Exemption (IDE) study for the company’s Galleri multi-cancer early detection (MCED) test…

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ASCO

Medicare Physician Conversion Factor Cut 3.37% for 2024

On November 2, 2023, the Centers for Medicare & Medicaid Services (CMS) released its final rule for the 2024 Medicare Physician Fee Schedule (MPFS) and updates to the Quality Payment Program (QPP). The agency also released the 2024 Medicare Hospital Outpatient Prospective Payment System (HOPPS) and Ambulatory Surgical Center (ASC) Payment System final rule, along with the 340B…

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What President Biden’s Executive Order On AI Means For Healthcare

On Monday, Oct. 29, President Joe Biden signed an executive order prioritizing the establishment of new safety, security, and fairness standards for artificial intelligence (AI), especially within the domain of healthcare. This directive mandates that developers of AI systems, particularly those bearing potential risks to public health and safety, must share their training data with…

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Tell Congress To Cancel The Cut!

As you well know, the flawed Medicare physician payment system is in desperate need of fixing and unfortunately things are about to get worse. Recently CMS announced final plans for payment schedules for physicians and spoiler alert, it’s not good! CMS approved a 3.4% reduction in Medicare’s physician payments for 2024. That means if Congress…

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ASCO

Telemedicine Flexibilities for Prescribing Controlled Medications Extended Through November 2024

  • Amanda Bridges
  • October 10, 2023
  • Drugs
  • No Comments

The Drug Enforcement Administration (DEA) issued a temporary rule that extends the ability to prescribe controlled substances via telemedicine without in an in-person visit through December 31, 2024. This extension authorizes DEA-registered practitioners to prescribe schedule II-V controlled medications via telemedicine through December 31, 2024, regardless of when the practitioner-patient relationship was established. The extension follows a temporary…

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FDA

FDA approves updated drug labeling including new indications and dosing regimens for capecitabine tablets under Project Renewal

  • Amanda Bridges
  • December 15, 2022
  • Drugs
  • No Comments

On December 14, 2022, the Food and Drug Administration approved updated labeling for capecitabine tablets (Xeloda, Genentech, Inc.) under Project Renewal, an Oncology Center of Excellence (OCE) initiative aimed at updating labeling information for certain older oncology drugs to ensure information is clinically meaningful and scientifically up to date. This is the first drug to…

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FDA

FDA grants accelerated approval to adagrasib for KRAS G12C-mutated NSCLC

  • Amanda Bridges
  • December 13, 2022
  • Drugs
  • No Comments

On December 12, 2022, the Food and Drug Administration (FDA) granted accelerated approval to adagrasib (Krazati, Mirati Therapeutics, Inc.), a RAS GTPase family inhibitor, for adult patients with KRAS G12C¬-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy. FDA…

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FDA

FDA approves olutasidenib for relapsed or refractory acute myeloid leukemia with a susceptible IDH1 mutation

  • Amanda Bridges
  • December 1, 2022
  • Drugs
  • No Comments

On December 1, 2022, the Food and Drug Administration (FDA) approved olutasidenib (Rezlidhia) capsules for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test. Today, the FDA also approved the Abbott RealTime IDH1 Assay to select patients for olutasidenib. Approval was based on Study 2102-HEM-101…

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FDA

FDA investigating risk of severe hypocalcemia in patients on dialysis receiving osteoporosis medicine Prolia (denosumab)

  • Amanda Bridges
  • November 22, 2022
  • Drugs
  • No Comments

The U.S. Food and Drug Administration (FDA) is investigating the risk of severe hypocalcemia with serious outcomes, including hospitalization and death, in patients with advanced kidney disease on dialysis treated with the osteoporosis medicine Prolia (denosumab). Our review of interim results from an ongoing safety study of Prolia suggests an increased risk of hypocalcemia, or…

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FDA

FDA approves a new dosing regimen for asparaginase erwinia chrysanthemi (recombinant)

  • Amanda Bridges
  • November 18, 2022
  • Drugs
  • No Comments

On November 18, 2022, the Food and Drug Administration approved a new Monday-Wednesday-Friday dosing regimen for asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze, Jazz Pharmaceuticals). Under the new regimen, patients should receive 25 mg/m2 intramuscularly on Monday and Wednesday mornings, and 50 mg/m2 intramuscularly on Friday afternoon. It also is approved to be administered every 48 hours…

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FDA

FDA grants accelerated approval to mirvetuximab soravtansine-gynx for FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or peritoneal cancer

  • Amanda Bridges
  • November 16, 2022
  • Drugs
  • No Comments

On November 14, 2022, the Food and Drug Administration granted accelerated approval to mirvetuximab soravtansine-gynx (Elahere, ImmunoGen, Inc.) for adult patients with folate receptor alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Mirvetuximab soravtansine-gynx is a folate receptor alpha directed antibody…

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Seagen

FDA approves brentuximab vedotin in combination with chemotherapy for pediatric patients with classical Hodgkin lymphoma

  • Amanda Bridges
  • November 10, 2022
  • Drugs
  • No Comments

On November 10, 2022, the Food and Drug Administration approved brentuximab vedotin (Adcetris, Seagen, Inc.) in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide for pediatric patients 2 years of age and older with previously untreated high risk classical Hodgkin lymphoma (cHL). This is the first pediatric approval for brentuximab vedotin. Efficacy was evaluated in…

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FDA

FDA approves selpercatinib for locally advanced or metastatic RET fusion-positive non-small cell lung cancer

  • Amanda Bridges
  • September 22, 2022
  • Drugs
  • No Comments

On September 21, 2022, the Food and Drug Administration granted regular approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test. Today, FDA also approved the Oncomine Dx Target (ODxT)…

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FDA

FDA approves selpercatinib for locally advanced or metastatic RET fusion-positive solid tumors

  • Amanda Bridges
  • September 22, 2022
  • Drugs
  • No Comments

On September 21, 2022, the Food and Drug Administration granted accelerated approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult patients with locally advanced or metastatic solid tumors with a rearranged during transfection (RET) gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options. Efficacy…

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FDA

FDA approves pemigatinib for relapsed or refractory myeloid/lymphoid neoplasms with FGFR1 rearrangement

  • Amanda Bridges
  • August 30, 2022
  • Drugs
  • No Comments

On August 26, 2022, the Food and Drug Administration approved pemigatinib (Pemazyre, Incyte Corporation) for adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with fibroblast growth factor receptor 1 (FGFR1) rearrangement. Efficacy was evaluated in FIGHT-203 (NCT03011372), a multicenter open-label, single-arm trial that included 28 patients with relapsed or refractory MLNs with FGFR1 rearrangement. Eligible…

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FDA

FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki for HER2-mutant non-small cell lung cancer

  • Amanda Bridges
  • August 12, 2022
  • Drugs
  • No Comments

On August 11, 2022, the Food and Drug Administration granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating human epidermal growth factor receptor 2 HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a…

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FDA

FDA approves darolutamide tablets for metastatic hormone-sensitive prostate cancer

  • Amanda Bridges
  • August 7, 2022
  • Drugs
  • No Comments

On August 5, 2022, the Food and Drug Administration approved darolutamide (Nubeqa, Bayer HealthCare Pharmaceuticals Inc.) tablets in combination with docetaxel for adult patients with metastatic hormone-sensitive prostate cancer (mHSPC). Efficacy was based on ARASENS (NCT02799602), a randomized, multicenter, double-blind, placebo-controlled clinical trial in 1306 patients with mHSPC. Patients were randomized to receive either darolutamide…

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Pfizer

FDA approves crizotinib for ALK-positive inflammatory myofibroblastic tumor

  • Amanda Bridges
  • July 14, 2022
  • Drugs
  • No Comments

On July 14, 2022, the Food and Drug Administration approved crizotinib (Xalkori, Pfizer Inc.) for adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory anaplastic lymphoma kinase (ALK)-positive myofibroblastic tumors (IMT). The safety and efficacy of crizotinib were evaluated in two multicenter, single-arm, open-label trials that included 14…

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FDA

FDA warns about possible increased risk of death and serious side effects with cancer drug Copiktra (duvelisib)

  • Amanda Bridges
  • June 30, 2022
  • Drugs
  • No Comments

What safety concern is FDA announcing? The U.S. Food and Drug Administration (FDA) is warning that results from a clinical trial show a possible increased risk of death with Copiktra (duvelisib) compared to another medicine to treat a chronic blood cancer called leukemia and a lymphoma, a cancer found in the lymph nodes. The trial…

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FDA

FDA approves lisocabtagene maraleucel for second-line treatment of large B-cell lymphoma

  • Amanda Bridges
  • June 27, 2022
  • Drugs
  • No Comments

On June 24, 2022, the Food and Drug Administration approved lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc.) for adult patients with large B-cell lymphoma (LBCL) who have refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for…

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FDA

FDA grants accelerated approval to dabrafenib in combination with trametinib for unresectable or metastatic solid tumors with BRAF V600E mutation

  • Amanda Bridges
  • June 23, 2022
  • Drugs
  • No Comments

On June 22, 2022, the Food and Drug Administration granted accelerated approval to dabrafenib (Tafinlar, Novartis) in combination with trametinib (Mekinist, Novartis) for the treatment of adult and pediatric patients ≥ 6 years of age with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory…

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FDA

FDA approves Opdivo in combination with chemotherapy and Opdivo in combination with Yervoy for first-line esophageal squamous cell carcinoma indications

  • Amanda Bridges
  • June 1, 2022
  • Drugs
  • No Comments

On May 27, 2022, the Food and Drug Administration approved the following for the first-line treatment of patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC): nivolumab (Opdivo, Bristol-Myers Squibb Company) in combination with fluoropyrimidine- and platinum-based chemotherapy nivolumab in combination with ipilimumab (Yervoy, Bristol-Myers Squibb Company) Efficacy was evaluated in CHECKMATE-648 (NCT03143153), a…

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FDA

FDA approves tisagenlecleucel for relapsed or refractory follicular lymphoma

  • Amanda Bridges
  • June 1, 2022
  • Drugs
  • No Comments

On May 27, 2022, the Food and Drug Administration granted accelerated approval to tisagenlecleucel (Kymriah, Novartis Pharmaceuticals Corporation) for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. The approval was based on the ELARA trial (NCT03568461), a multicenter, single-arm, open-label trial evaluating tisagenlecleucel, a CD19-directed chimeric…

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FDA

FDA approval of lymphoma medicine Ukoniq (umbralisib) is withdrawn due to safety concerns

  • Amanda Bridges
  • June 1, 2022
  • Drugs
  • No Comments

6-1-2022 FDA Drug Safety Communication Due to safety concerns, the U.S. Food and Drug Administration (FDA) has withdrawn its approval for the cancer medicine Ukoniq (umbralisib). Ukoniq was approved to treat two specific types of lymphoma: marginal zone lymphoma (MZL) and follicular lymphoma (FL). Updated findings from the UNITY-CLL clinical trial continued to show a…

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FDA

FDA approves alpelisib for PIK3CA-related overgrowth spectrum

  • Amanda Bridges
  • April 6, 2022
  • Drugs
  • No Comments

On April 5, 2022, the Food and Drug Administration granted accelerated approval to alpelisib (Vijoice, Novartis Pharmaceuticals) for adult and pediatric patients two years of age and older with severe manifestations of PIK3CA-related overgrowth spectrum (PROS) who require systemic therapy. Efficacy was evaluated using real-world data from EPIK-P1 (NCT04285723), a single-arm clinical study in patients…

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FDA

FDA approves axicabtagene ciloleucel for second-line treatment of large B-cell lymphoma

  • Amanda Bridges
  • April 1, 2022
  • Drugs
  • No Comments

On April 1, 2022, the Food and Drug Administration approved axicabtagene ciloleucel (Yescarta, Kite Pharma, Inc.) for adult patients with large B-cell lymphoma (LBCL) that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy. It is not indicated for the treatment of patients with primary central nervous system lymphoma. Approval was…

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FDA

FDA approves Pluvicto for metastatic castration-resistant prostate cancer

  • Amanda Bridges
  • March 24, 2022
  • Drugs
  • No Comments

On March 23, 2022, the Food and Drug Administration approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan, Advanced Accelerator Applications USA, Inc., a Novartis company) for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy.  On the…

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Bristol Myers Squibb

FDA approves Opdualag for unresectable or metastatic melanoma

  • Amanda Bridges
  • March 21, 2022
  • Drugs
  • No Comments

On March 18, 2022, the Food and Drug Administration approved nivolumab and relatlimab-rmbw (Opdualag, Bristol-Myers Squibb Company) for adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. Opdualag is a fixed-dose combination of the LAG-3-blocking antibody relatlimab and the programmed death receptor-1 blocking antibody nivolumab. Efficacy was evaluated in…

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FDA

FDA investigating possible increased risk of death with lymphoma medicine Ukoniq (umbralisib)

  • Amanda Bridges
  • February 3, 2022
  • Drugs
  • No Comments

2-3-2022 FDA Drug Safety Communication The U.S. Food and Drug Administration (FDA) is investigating a possible increased risk of death with the cancer medicine Ukoniq (umbralisib) approved to treat two specific types of lymphomas, which are cancers that affect the body’s immune system. We determined that initial findings from a clinical trial evaluating Ukoniq to…

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FLASCO

FDA approves rituximab plus chemotherapy for pediatric cancer indications

  • Amanda Bridges
  • December 3, 2021
  • Drugs
  • No Comments

On December 2, 2021, the Food and Drug Administration approved rituximab (Rituxan, Genentech, Inc.) in combination with chemotherapy for pediatric patients (≥6 months to <18 years) with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL), or mature B-cell acute leukemia (B-AL).  Efficacy was evaluated in Inter-B-NHL Ritux 2010 (NCT01516580), a global multicenter, open-label, randomized (1:1) trial of…

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Amgen

FDA approves Darzalex Faspro, Kyprolis, and Dexamethasone for Multiple Myeloma

  • Amanda Bridges
  • December 1, 2021
  • Drugs
  • No Comments

On November 30, 2021, the Food and Drug Administration approved daratumumab + hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) and carfilzomib (Kyprolis, Amgen, Inc.) plus dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy. Efficacy was evaluated in a single-arm cohort of PLEIADES (NCT03412565), a…

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FDA

FDA approves sirolimus protein-bound particles for malignant perivascular epithelioid cell tumor

  • Amanda Bridges
  • November 23, 2021
  • Drugs
  • No Comments

On November 22, 2021, the Food and Drug Administration approved sirolimus protein-bound particles for injectable suspension (albumin-bound) (Fyarro, Aadi Bioscience, Inc.) for adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).  Efficacy was evaluated in AMPECT (NCT02494570), a multicenter, single-arm clinical trial in 31 patients with locally advanced unresectable or…

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Novartis Oncology

FDA approves asciminib for Philadelphia chromosome-positive chronic myeloid leukemia

  • Amanda Bridges
  • October 29, 2021
  • Drugs
  • No Comments

On October 29, 2021, the Food and Drug Administration granted accelerated approval to asciminib (Scemblix, Novartis AG) for patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously treated with two or more tyrosine kinase inhibitors (TKIs), and approved asciminib for adult patients with Ph+ CML in CP with the T315I…

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Genentech

FDA approves atezolizumab as adjuvant treatment for non-small cell lung cancer

  • Amanda Bridges
  • October 15, 2021
  • Drugs
  • No Comments

On October 15, 2021, the Food and Drug Administration approved atezolizumab (Tecentriq, Genentech, Inc.) for adjuvant treatment following resection and platinum-based chemotherapy in patients with stage II to IIIA non-small cell lung cancer (NSCLC) whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-approved test.  Today, the FDA also approved the VENTANA PD-L1 (SP263) Assay (Ventana Medical Systems, Inc.) as a companion diagnostic device…

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Merck

FDA approves pembrolizumab combination for the first-line treatment of cervical cancer

  • Amanda Bridges
  • October 13, 2021
  • Drugs
  • No Comments

On October 13, 2021, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) in combination with chemotherapy, with or without bevacizumab, for patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1), as determined by an FDA-approved test.  FDA also granted regular approval to pembrolizumab as a single agent for patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors…

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FDA

FDA approves abemaciclib with endocrine therapy for early breast cancer

  • Amanda Bridges
  • October 13, 2021
  • Drugs
  • No Comments

On October 12, 2021, the Food and Drug Administration approved abemaciclib (Verzenio, Eli Lilly and Company) with endocrine therapy (tamoxifen or an aromatase inhibitor) for adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence and a Ki-67 score ≥20%, as determined by an FDA approved test. This is the first CDK 4/6 inhibitor approved for adjuvant treatment…

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FLASCO

FDA recognizes Memorial Sloan-Kettering database of molecular tumor marker information

  • Amanda Bridges
  • October 8, 2021
  • Drugs
  • No Comments

On October 7, 2021, the Food and Drug Administration granted recognition to a partial listing of the Memorial Sloan Kettering Cancer Center’s Oncology Knowledge Base (OncoKB) as the first tumor mutation database to be included in the Public Human Genetic Variant Databases.  FDA recognized a portion of the OncoKB as a source of valid scientific evidence for Level 2 (clinical significance) and Level 3 (potential clinical significance) biomarkers. Under the FDA’s database…

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FLASCO

Florida Cancer Specialists & Research Institute Names Michael Diaz, MD as President & Managing Physician

  • Amanda Bridges
  • October 4, 2021
  • News
  • No Comments

Medical Oncologist to Succeed Lucio Gordan, MD in 2022 Fort Myers, Fla., September 30, 2021 – Florida Cancer Specialists & Research Institute (FCS) is pleased to announce that Michael Diaz, MD will assume the role of President & Managing Physician, effective January 1, 2022.  He succeeds Lucio Gordan, MD, who has served in that position since…

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Kite

FDA approves brexucabtagene autoleucel for relapsed or refractory B-cell precursor acute lymphoblastic leukemia

  • Amanda Bridges
  • October 4, 2021
  • Drugs
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On October 1, 2021, the Food and Drug Administration approved brexucabtagene autoleucel (Tecartus, Kite Pharma, Inc.) for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Efficacy was evaluated in ZUMA-3 (NCT02614066), a single-arm multicenter trial that evaluated brexucabtagene autoleucel, a CD19-directed chimeric antigen receptor (CAR) T-cell therapy, in adults with relapsed…

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Incyte

FDA approves ruxolitinib for chronic graft-versus-host disease

  • Amanda Bridges
  • September 23, 2021
  • Drugs
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On September 22, 2021, the Food and Drug Administration approved ruxolitinib (Jakafi, Incyte Corp.) for chronic graft-versus-host disease (cGVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. Efficacy was evaluated in REACH-3 (NCT03112603), a randomized, open-label, multicenter clinical trial of ruxolitinib compared to best…

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FLASCO

FDA approves cabozantinib for differentiated thyroid cancer

  • Amanda Bridges
  • September 22, 2021
  • Drugs
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On September 17, 2021, the Food and Drug Administration approved cabozantinib (Cabometyx, Exelixis, Inc.) for adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior VEGFR-targeted therapy and who are ineligible or refractory to radioactive iodine. Efficacy was evaluated in COSMIC-311,…

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Seagen

FDA grants accelerated approval to tisotumab vedotin-tftv for recurrent or metastatic cervical cancer

  • Amanda Bridges
  • September 21, 2021
  • Drugs
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On September 20, 2021, the Food and Drug Administration granted accelerated approval to tisotumab vedotin-tftv (Tivdak, Seagen Inc.), a tissue factor-directed antibody and microtubule inhibitor conjugate, for adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Approval was based on innovaTV 204, an open-label, multicenter, single-arm clinical trial (NCT03438396)….

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FMA

How the new DNA privacy law could affect your practice

  • Amanda Bridges
  • September 20, 2021
  • News
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Under the Protecting DNA Privacy Act (HB 833), signed into law by Gov. Ron DeSantis on June 29, collecting or submitting another person’s DNA sample for analysis without his or her express consent now constitutes a second-degree felony in the state of Florida. While this legislation was intended to prevent the unauthorized use of personal DNA information,…

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AMA

American Medical Association – Prior Authorization and Utilization Management Reform Principles

  • Amanda Bridges
  • September 20, 2021
  • News
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Patient-centered care has emerged as a major common goal across the health care industry. By empowering patients to play an active role in their care and assume a pivotal role in developing an individualized treatment plan to meet their health care needs, this care model can increase patients’ satisfaction with provided services and ultimately improve…

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Takeda

FDA grants accelerated approval to mobocertinib for metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations

  • Amanda Bridges
  • September 16, 2021
  • Drugs
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On September 15, 2021, the Food and Drug Administration granted accelerated approval to mobocertinib (Exkivity, Takeda Pharmaceuticals, Inc.) for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based…

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Beigene

FDA approves zanubrutinib for Waldenström’s macroglobulinemia

  • Amanda Bridges
  • September 2, 2021
  • Drugs
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On August 31, 2021, the Food and Drug Administration approved zanubrutinib (Brukinsa, BeiGene) for adult patients with Waldenström’s macroglobulinemia (WM). Zanubrutinib was investigated in ASPEN (NCT03053440), a randomized, active control, open-label trial, comparing zanubrutinib and ibrutinib in patients with MYD88 L265P mutation (MYD88MUT) WM. Patients in Cohort 1 (n=201) were randomized 1:1 to receive zanubrutinib…

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FDA approves ivosidenib for advanced or metastatic cholangiocarcinoma

  • Amanda Bridges
  • August 27, 2021
  • Drugs
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On August 25, 2021, the Food and Drug Administration approved ivosidenib (Tibsovo, Servier Pharmaceuticals LLC) for adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test. Today, the FDA also approved the Oncomine Dx Target Test (Life Technologies Corporation) as a companion diagnostic…

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Bristol Myers Squibb

FDA approves nivolumab for adjuvant treatment of urothelial carcinoma

  • Amanda Bridges
  • August 20, 2021
  • Drugs
  • No Comments

On August 19, 2021, the Food and Drug Administration approved nivolumab (Opdivo, Bristol-Myers Squibb Co.) for the adjuvant treatment of patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection. This is the first FDA approval for adjuvant treatment of patients with high-risk UC. The results supporting this approval…

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GlaxoSmithKline

FDA grants accelerated approval to dostarlimab-gxly for dMMR advanced solid tumors

  • Amanda Bridges
  • August 18, 2021
  • Drugs
  • No Comments

On August 17, 2021, the Food and Drug Administration granted accelerated approval to dostarlimab-gxly (Jemperli, GlaxoSmithKline LLC) for adult patients with mismatch repair deficient (dMMR) recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options. Today, the FDA…

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Merck

FDA approves belzutifan for cancers associated with von Hippel-Lindau disease

  • Amanda Bridges
  • August 13, 2021
  • Drugs
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On August 13, 2021, the Food and Drug Administration approved belzutifan (Welireg, Merck), a hypoxia-inducible factor inhibitor for adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery. Belzutifan was investigated in the ongoing Study…

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Merck

FDA approves pembrolizumab for high-risk early-stage triple-negative breast cancer

  • Amanda Bridges
  • July 27, 2021
  • Drugs
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On July 26, 2021, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) for high-risk, early-stage, triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. FDA also granted regular approval to pembrolizumab in combination with chemotherapy for patients with locally recurrent…

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Merck

FDA grants regular approval to pembrolizumab and lenvatinib for advanced endometrial carcinoma

  • Amanda Bridges
  • July 23, 2021
  • Drugs
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On July 21, 2021, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) in combination with lenvatinib (Lenvima, Eisai) for patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or…

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FLASCO

FDA approves belumosudil for chronic graft-versus-host disease

  • Amanda Bridges
  • July 16, 2021
  • Drugs
  • No Comments

On July 16, 2021, the Food and Drug Administration approved belumosudil (Rezurock, Kadmon Pharmaceuticals, LLC), a kinase inhibitor, for adult and pediatric patients 12 years and older with chronic graft-versus-host disease (chronic GVHD) after failure of at least two prior lines of systemic therapy. Efficacy was evaluated in KD025-213 (NCT03640481), a randomized, open-label, multicenter dose-ranging…

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