FLASCO / News

A Phase 3 Study of elacestrant versus standard endocrine therapy in node-positive ER+, HER2- early breast cancer with high risk of recurrence (ELEGANT)

Kelly Wilson
November 22, 2024
Clinical Trials
No Comments

Despite advances in the adjuvant treatment of early-stage estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer, there continues to be a risk of recurrence. The ELEGANT study is a Global, Multicenter, Randomized, Open-label Phase 3 Study with the primary goal to evaluate the efficacy and safety of elacestrant versus standard endocrine…

Applications Are Open for the ASCO Quality Training Program (QTP)

Kelly Wilson
October 25, 2024
News
No Comments

ASCO’s Quality Training Program (QTP) Winter 2025 Session will be on the following dates, hosted by Memorial Healthcare System in Pembroke Pines, Florida: Learning Session 0 (Orientation): Thursday, December 5, 2024 (Virtual) Learning Session 1: Thursday, January 9 – Friday, January 10, 2025 (in-person) Learning Session 2: Thursday, March 6 – Friday, March 7, 2025…

Merit-based Incentive Payment System (MIPS) Automatic Extreme and Uncontrollable Circumstances (EUC) Policy Applied to MIPS Eligible Clinicians Following Hurricanes Helene and Francine

Kelly Wilson
October 25, 2024
Clinical Practice Updates
No Comments

The U.S. Department of Health and Human Services (HHS) Secretary Becerra recently released a letter to healthcare leaders and stakeholders on the impacts of Hurricane Helene, which can be found on the HHS website. In response to Hurricanes Helene and Francine, the Centers for Medicare & Medicaid Services (CMS) has determined that the MIPS automatic…

New Protocol Updates Available For The National Gold Card Program

Kelly Wilson
September 20, 2024
Clinical Practice Updates
No Comments

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.

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)….

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

Kelly Wilson
August 28, 2024
Legislative Updates
No Comments

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…

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

Kelly Wilson
August 28, 2024
Clinical Practice Updates
No Comments

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…

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

Kelly Wilson
August 28, 2024
Clinical Practice Updates
No Comments

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…

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

Kelly Wilson
August 28, 2024
Clinical Practice Updates
No Comments

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,…

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

Kelly Wilson
August 19, 2024
Clinical Practice Updates
No Comments

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…

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

Kelly Wilson
July 22, 2024
Clinical Practice Updates
No Comments

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…

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

Kelly Wilson
June 27, 2024
Legislative Updates
No Comments

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…

CMS Opens Registration for Second Oncology Payment Model Cohort on July 1

Kelly Wilson
June 24, 2024
Clinical Practice Updates
No Comments

The Centers for Medicare & Medicaid Services Innovation Center (CMMI) announced it is reopening the Enhancing Oncology Model for a second cohort of participants and payers. The second cohort will begin on July 1, 2025, and end on June 30, 2030, for a 5-year model performance period. For more details and eligibility criteria, please read…

Bipartisan, ASCO-Endorsed Prior Authorization Bill Reintroduced in Congress

Kelly Wilson
June 24, 2024
Legislative Updates
No Comments

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…

Nationwide Recall of Docetaxel Issued Over Particulate Concerns

Kelly Wilson
June 7, 2024
Clinical Practice Updates
No Comments

On May 28, Sagent Pharmaceuticals announced a voluntary nationwide recall of two lots of docetaxel injection (80 mg per 8 mL multidose vials and 160 mg per 16 mL multidose vials). The move was prompted by a customer complaint regarding possible particulate matter. Although no adverse events have been reported thus far, injection of particulate…

New Cervical Cancer Guidelines Released

Kelly Wilson
March 26, 2024
Clinical Practice Updates
No Comments

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…

Judge Grants Biden Administration Motion to Dismiss Legal Challenge from PhRMA

Kelly Wilson
February 26, 2024
Legislative Updates
No Comments

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…

Session Midpoint Report: What Physicians Should Know

Kelly Wilson
February 21, 2024
Legislative Updates
No Comments

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…

2024 MEDPARD Available Now!

Kelly Wilson
February 21, 2024
Clinical Practice Updates
No Comments

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.

CMS Releases Guidance for Code G2211

Kelly Wilson
February 1, 2024
Clinical Practice Updates
No Comments

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…

Congress Passes Bill to Fund Government into March

Kelly Wilson
January 25, 2024
Legislative Updates
No Comments

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…

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…

CMS Releases Final Rule on Prior Authorization and Interoperability

Kelly Wilson
January 17, 2024
Clinical Practice Updates
No Comments

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)…

House Speaker Renner Backs Senate President Passidomo On Health Care Plan

Kelly Wilson
January 11, 2024
Legislative Updates
No Comments

House Speaker Paul Renner and Senate President Kathleen Passidomo say they are co-signing on each other’s health care priorities, including Passidomo’s Live Healthy package. The $900 million proposal includes two bills (SB 7016, SB 7018) designed to increase the number of doctors, while encouraging technological innovation.

Tell Congress To Eliminate 3.37% Payment Cut

Kelly Wilson
January 11, 2024
Legislative Updates
No Comments

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…

New Guidance on Medicare Inflation Rebates Adjusts for Drug Shortages

Amanda Bridges
December 21, 2023
Clinical Practice Updates
No Comments

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…

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…

Biden Administration Seeks to Uphold Trump-Era Copay Accumulator Rule

Kelly Wilson
December 14, 2023
Legislative Updates
No Comments

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.

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

Amanda Bridges
December 1, 2023
Clinical Practice Updates
No Comments

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…

Medicare Physician Conversion Factor Cut 3.37% for 2024

Amanda Bridges
November 13, 2023
Clinical Practice Updates
No Comments

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…

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

Amanda Bridges
November 9, 2023
Legislative Updates
No Comments

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…

Tell Congress To Cancel The Cut!

Amanda Bridges
November 9, 2023
Legislative Updates
No Comments

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…

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…

Pharmacy Benefit Managers (PBM) Reform

Amanda Bridges
January 6, 2023
Advocacy
No Comments

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…

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…

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…

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…

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…

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…

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…

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)…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

Living With Chronic Lymphocytic Leukemia (January 31, 2022)

Amanda Bridges
February 7, 2022
News
No Comments

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…

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…

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…

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…

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…

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…

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

Amanda Bridges
October 13, 2021
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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…

FDA approves abemaciclib with endocrine therapy for early breast cancer

Amanda Bridges
October 13, 2021
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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…

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

Amanda Bridges
October 8, 2021
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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…

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

Amanda Bridges
October 4, 2021
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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…

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

Amanda Bridges
October 4, 2021
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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…

FDA approves ruxolitinib for chronic graft-versus-host disease

Amanda Bridges
September 23, 2021
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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…

FDA approves cabozantinib for differentiated thyroid cancer

Amanda Bridges
September 22, 2021
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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,…

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

Amanda Bridges
September 21, 2021
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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)….

How the new DNA privacy law could affect your practice

Amanda Bridges
September 20, 2021
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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,…

American Medical Association – Prior Authorization and Utilization Management Reform Principles

Amanda Bridges
September 20, 2021
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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…

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

Amanda Bridges
September 16, 2021
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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…

FDA approves zanubrutinib for Waldenström’s macroglobulinemia

Amanda Bridges
September 2, 2021
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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…

FDA approves ivosidenib for advanced or metastatic cholangiocarcinoma

Amanda Bridges
August 27, 2021
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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…

FDA approves nivolumab for adjuvant treatment of urothelial carcinoma

Amanda Bridges
August 20, 2021
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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…

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

Amanda Bridges
August 18, 2021
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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…

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

Amanda Bridges
August 13, 2021
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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…