Alliance for Site Neutral Payment Reform Launches New Website

On September 12, The Alliance for Site Neutral Payment Reform launched a new website (www.siteneutral.org) to better educate lawmakers, industry stakeholders, and the public about the many benefits of advancing site neutral payment reforms across America’s healthcare delivery system. The website houses research and other resources on the value of payment parity across sites of…

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NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Older Adult Oncology. These NCCN Guidelines® are currently available as Version 2.2016.

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Older Adult Oncology. These NCCN Guidelines® are currently available as Version 2.2016.  Disease-Specific Issues Related to Age/Central Nervous System Cancers: (OAO-B 8 of 32) The recommendations for adjuvant therapy for newly diagnosed patients with glioblastoma multiforme (GBM) were revised as…

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FDA Modifies nivolumab Dosing for Three Indications

On September 13, 2016, the U.S. Food and Drug Administration modified the dosage regimen for nivolumab (Opdivo, Bristol-Myers Squibb Co.) for the currently approved indications for renal cell carcinoma, metastatic melanoma, and non-small cell lung cancer. The currently approved recommended dosage regimens were modified to 240 mg intravenously (IV) every two weeks. The approval modifies the…

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Congratulations to Sylvester Comprehensive Cancer Center

  • FLASCO
  • September 16, 2016
  • News
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We are pleased to announce that the Sylvester Comprehensive Cancer Center, part of UHealth – the University of Miami Health System, has earned a Lung Cancer Screening Center Designation by  the American College of Radiation.   The lung cancer screening program at Sylvester Comprehensive Cancer Center, part of UHealth – the University of Miami Health…

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CMS Correcting Errors to Updated Coverage Policy for Genetic Tests

  ASCO has confirmed that CMS is currently working to correct technical errors that occurred when they recently updated national coverage policies regarding certain genetic tests. CMS confirms that steps are being taken to reprocess claims that have been denied.   According to CMS, the errors occurred during the mapping process from ICD-9 to ICD-10. During…

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FDA Approves BLINCYTO® (blinatumomab) For Use In Pediatric Patients With Philadelphia Chromosome-Negative Relapsed Or Refractory B-cell Precursor Acute Lymphoblastic Leukemia

Amgen  announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for BLINCYTO®(blinatumomab) to include new data supporting the treatment of pediatric patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). This indication is approved under accelerated approval, and continued approval may be…

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Cigna Revises Policy, Will Cover 3D Mammography For Breast Cancer Screening

Cigna has revised its medical coverage policy for breast cancer screening and will now cover three-dimensional (3D) mammography for routine breast cancer screening. Under its previous policy, the company covered 3D mammography for diagnostic purposes, but not for routine screening.   The policy had been based on guidance from the U.S. Preventive Services Task Force…

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New NCCN Imaging Appropriate Use Criteria Published for Eight Cancer Types

The National Comprehensive Cancer Network® (NCCN®), a Centers for Medicare & Medicaid Services (CMS)-approved provider-led entity for imaging appropriate use criteria (AUC), continues to build its library of AUC and has published NCCN Imaging Appropriate Use Criteria (NCCN Imaging AUC™) for eight new cancer types. Launched in June 2016, NCCN Imaging AUC™ currently are available…

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Genmab Announces U.S. FDA Approval of Arzerra (ofatumumab) in Combination with Fludarabine and Cyclophosphamide for Relapsed CLL – (Novartis)

  • FLASCO
  • September 16, 2016
  • Drugs
  • No Comments

Genmab A/S announced that the FDA has approved a supplemental Biologics License Application (sBLA) for the use of ofatumumab (Arzerra®) in combination with fludarabine and cyclophosphamide (FC) for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL). Read corporate press release »

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Update on the National Shortage of Bleomycin Sulfate for Injection

  • FLASCO
  • September 16, 2016
  • Drugs
  • No Comments

  The FDA announced efforts to help mitigate the shortage of Bleomycin Sulfate for Injection. The agency will be coordinating with Amneal Bioscience to import its Bleomycin Sulfate Powder for Injection, which contains the same active ingredients as the FDA-approved Bleomycin Sulfate for Injection.   In April, the FDA posted information on its website regarding…

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AfPA and Cancer Care Explore the Cancer Treatment Experience

  • FLASCO
  • September 16, 2016
  • News
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  Cancer patients may feel under-informed about their diagnosis, overwhelmed by out-of-pocket expenses and unable to carry out day-to-day activities – despite being confident about their quality of care. This narrative emerged during an August 9 webinar co-hosted by the Alliance for Patient Access and Cancer Care, which explored Cancer Care’s 2016 Patient Access & Engagement Report. The report included…

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AMERIGEN Announces Final Approval From FDA For Generic Version of Temodar®

Amerigen Pharmaceuticals Limited (“Amerigen”)  announced that the U.S. Food and Drug Administration (FDA) has granted final approval to the Company’s Abbreviated New Drug Application (ANDA) for a generic version of Temodar® (temozolomide capsules 5, 20, 100, 140, 180 and 250mg). The product has been launched and is manufactured by Stason Pharmaceuticals, Inc. (“Stason”) in Irvine,…

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Cigna – JW Modifier Start Date Update

FLASCO recently contacted Cigna on behalf of our 2,000 plus members requesting that Cigna reconsider the start date for the JW Modifier. It was pointed out to Cigna that Medicare had pushed the implementation back to 1/1/17. This will allow practices to ensure appropriate IT resources are in place to report the waste appropriately. At…

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Comprehensive Cancer Center at Broward Health Medical Center Named Affiliate Member of University of Florida for NRG Oncology

  • FLASCO
  • September 16, 2016
  • News
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The Comprehensive Cancer Center at Broward Health Medical Center (BHMC) has been granted Affiliate Membership by NRG Oncology – a non-profit research organization that conducts oncologic clinical research and broadly disseminates study results for informing clinical decision-making and healthcare policy. Broward Health North was also approved as an affiliate site. The membership grants BHMC the…

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Suncoast Cancer Institute Goes Above and Beyond

  • FLASCO
  • September 16, 2016
  • News
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Suncoast Cancer Institute in Sarasota, FL founder, Dr. Penny Heinrich, and Amy Akins, BSN, RN, OCN, both diligently worked on a patient’s behalf in concert with Walgreen’s to facilitate a lower drug cost. A Tarceva patient originally filled a prescription and was told they would have a $2000 co-pay amount, that the patient was unable…

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ASCO, SGO Update Guidelines On Role Of Chemo For Advanced Ovarian Cancer

  • FLASCO
  • September 16, 2016
  • News
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  All patients with stage IIIC or IV epithelial ovarian cancer associated with high clinical risk or a low likelihood of optimal surgical resection should receive neoadjuvant chemotherapy, according to a new clinical practice guideline. The recommendation pertains to women who have high-risk features such as older age or a high comorbidity burden or who…

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TYKERB®(lapatinib)NDC NUMBER CHANGE

TYKERB®(lapatinib)NDC NUMBER CHANGE Former GlaxoSmithKline (fGSK) Products EFFECTIVE IMMEDIATELY, please note that the current NDC numbers are being replaced by the  NEW NDC NUMBERS referenced in Table A below:   Table A: Product Name Old NDC # New NDC # Package Size Package Strength TYKERB® (lapatinib) 0173-0752-00 0078-0671-19 150 tablets 250mg   Direct Purchasers:Effective immediately,…

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PEMBROLIZUMAB (KEYTRUDA) Is Now Indicated For Recurrent or Metastatic HNSCC

  FDA granted accelerated approval to pembrolizumab (KEYTRUDA injection, Merck Sharp & Dohme Corp.) for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. Click here for Merck’s announcement   For More FDA Information Click Here   Medication Guide   Prescribing Information…

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foundation medicine

Foundation Medicine Launches Blood-Based Liquid Biopsy, FoundationACT

  Foundation Medicine has launched a new assay, FoundationACT (Assay for Circulating Tumor DNA), a rigorously validated and highly accurate blood-based circulating tumor DNA (ctDNA) assay that provides patients and oncologists with a new option for comprehensive genomic profiling when a tissue biopsy is not feasible or when tissue is not available. By analyzing cell-free…

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Infusion Pump Billing Update

CMS recently provided additional clarification to MACs and providers regarding reimbursement for prolonged drug and biological infusions that are started in the office or outpatient hospital and are associated with care that is billed incident to a physician service using an external pump. In order for Medicare to pay for a drug or biological, the…

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AbbVie and Bristol-Myers Squibb Announce Oncology Clinical Collaboration to Evaluate the Combination of Rova-T plus Opdivo and Opdivo + Yervoy Regimen

  AbbVie and Bristol-Myers Squibb Company  announced a clinical trial collaboration to evaluate the safety, tolerability and efficacy of AbbVie’s investigational biomarker-specific antibody drug conjugate Rova-T (rovalpituuzumab tesirine) in combination with Bristol-Myers Squibb’s Opdivo (nivolumab) and Opdivo + Yervoy (ipilimumab) regimen as a treatment for relapsed extensive-stage small cell lung cancer (SCLC). The Phase 1/2…

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FDA Approved

FDA clears first quantitative nucleic acid assay for BCR-ABL

Molecular Test to Guide CML Therapy OK’d FDA clears first quantitative nucleic acid assay for BCR-ABL A molecular diagnostic for measuring BCR-ABL levels in patients with chronic myeloid leukemia (CML) was cleared for marketing Friday, the FDA announced. It’s the first quantitative nucleic acid assay for this purpose to be approved in the U.S., the…

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Merck is pleased to announce that EMEND for oral suspension is now available.

Merck is pleased to announce that EMEND for oral suspension is now available. (Click the below image to enlarge)     EMEND® is a substance P/neurokinin 1 (NK1) receptor antagonist. EMEND for oral suspension is indicated in combination with other antiemetic agents, in patients 6 months of age and older for prevention of: acute and delayed nausea and…

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NCCN Guidelines Updated

  • FLASCO
  • August 11, 2016
  • News
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NCCN has published NEW NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) with NCCN Evidence Blocks™ for the following disease type: Testicular Cancer, Version 2.2016 NCCN has published updates to the NCCN Guidelines® and NCCN Drugs & Biologics Compendium (NCCN Compendium®) for Small Cell Lung Cancer. These NCCN Guidelines are currently available as Version 1.2017.  Adjuvant…

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Heron-therapeutics

Heron Therapeutics Announces U.S. FDA Approval of SUSTOL® (granisetron) Extended-Release Injection for the Prevention of Chemotherapy-Induced Nausea and Vomiting

Heron Therapeutics Announces U.S. FDA Approval of SUSTOL® (granisetron) Extended-Release Injection for the Prevention of Chemotherapy-Induced Nausea and Vomiting SUSTOL is the first extended-release 5-HT3 receptor antagonist approved for the prevention of acute and delayed nausea and vomiting associated with both moderately emetogenic chemotherapy and anthracycline and cyclophosphamide combination chemotherapy regimens A standard of care…

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Independent Payment Advisory Board (IPAB) What is Happening Now  (Source:  Policy & Medicine)

  The Independent Payment Advisory Board (IPAB) is one of the “cost control mechanisms” that can be found within the Affordable Care Act (ACA) and is designed to bring per-capita Medicare spending back in line with statutory benchmarks, if those benchmarks are exceeded. While an IPAB trigger was avoided this year, the IPAB continues to…

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FDA Approved pembrolizumab (KEYTRUDA) for Recurrent or Metastatic HNSCC

On August 5, 2016, the U. S. Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA injection, Merck Sharp & Dohme Corp.) for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. The approval was based on demonstration of a…

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CMS Releases Proposed Medicare Payment Rules for 2017

The Centers for Medicare and Medicaid Services (CMS) has issued two proposed rules to update payment policies and payment rates for services furnished under the Medicare Physician Fee Schedule (PFS) and the Hospital Outpatient Prospective Payment System (OPPS). CMS will be accepting comments on these rules until September 6, 2016. The final rules are expected…

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NCCN has published updates to the NCCN Guidelines for Breast Cancer Screening and Diagnosis.

  • FLASCO
  • August 8, 2016
  • News
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NCCN has published updates to the NCCN Guidelines for Breast Cancer Screening and Diagnosis. These NCCN Guidelines are currently available as Version 1.2016.  “Clinical Breast Exam” was changed to “Clinical Encounter” with the footnote stating, “Clinical encounter should encompass ongoing risk assessment, risk reduction counseling, as well as a clinical breast exam.” (BSCR-1) “Consider tomosynthesis” is a…

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NCCN has published updates to the NCCN Guidelines and the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for Central Nervous System Cancers. These NCCN Guidelines are currently available as Version 1.2016.

  • FLASCO
  • August 8, 2016
  • News
  • No Comments

NCCN has published updates to the NCCN Guidelines and the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for Central Nervous System Cancers. These NCCN Guidelines are currently available as Version 1.2016.   Anaplastic Gliomas (GLIO-2) The following adjuvant treatment option has been removed for 1p19q codeleted anaplastic oligodendroglioma/anaplastic oligoastrocytoma: PCV or temozolomide chemotherapy (category 2B). Glioblastoma…

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NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) and NCCN Drugs & Biologics Compendium (NCCN Compendium®) for Cancer-Associated Venous Thromboembolic Disease. These NCCN Guidelines® are currently available as Version 1.2016.

  • FLASCO
  • August 8, 2016
  • News
  • No Comments

Venous Thromboembolism Prophylaxis VTE Prophylaxis Following Discharge and for Ambulatory Cancer Patients at Risk (VTE-2) For medical oncology patients in other outpatient settings (ie, those without multiple myeloma), the following footnote was removed: “Consider patient conversation about risks and benefits of VTE prophylaxis in patients with a Khorana score ≥3. (See Khorana Predictive Model [VTE-A…

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paradigm logo

Independent Clinical Study Published Demonstrating Clinical Utility of the Paradigm Cancer Diagnostic (PCDx) Test

An independent, peer-reviewed clinical study published today in Oncotarget entitled “Clinical Benefit of A Precision Medicine Based Approach For Guiding Treatment of Refractory Cancers” provides additional data supporting the clinical utility of the Paradigm PCDx test to significantly help improve outcomes for patients with cancer. This independent study was performed by the Indiana University Health…

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NCCN has published updates to the NCCN Guidelines and Chemo Order Templates

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Melanoma. These NCCN Guidelines® are currently available as Version 3.2016.  Imaging recommendations were clarified, including the following: Addition of footnote “i”, specifying modalities wherever imaging is mentioned: “Chest/abdominal/pelvic CT with contrast, brain MRI with contrast, and/or FDG PET/CT. Neck CT with…

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New Executive Medical Director at Florida Hospital

  • FLASCO
  • July 13, 2016
  • News
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Mark A. Socinski, MD, has been appointed Executive Medical Director of the Florida Hospital Cancer Institute. In his role, he will oversee the coordination of clinical cancer services for the Florida Hospital network. He will also be an active member of the Institute’s Thoracic Oncology Program. Dr. Socinski has spent more than 20 years in…

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Insys Therapeutics Announces FDA Approval of Syndros™

Insys Therapeutics, Inc. (“Insys” or “the Company”) (INSY) today announced that the U.S. Food and Drug Administration (FDA) has approved Insys’ dronabinol oral solution, SyndrosTM, an orally administered liquid formulation of the pharmaceutical cannabinoid dronabinol, a pharmaceutical version of tetrahydrocannabinol (“THC”). Syndros is approved for use in treating anorexia associated with weight loss in patients…

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NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Ovarian Cancer

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Ovarian Cancer. These NCCN Guidelines® are currently available as Version 1.2016.  ·         For patients with a suspicious palpable mass and/or symptoms, the following primary treatment option has been revised: “Patients with bulky stage III/IV who are poor surgical candidates due…

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HHS Announces Physician Groups Selected for an Initiative Promoting Better Cancer Care

  • FLASCO
  • June 29, 2016
  • News
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HHS Oncology Care Model attracts almost twice the expected number of physician group practices The U.S. Department of Health and Human Services (HHS) today announced that it has selected nearly 200 physician group practices and 17 health insurance companies to participate in a care delivery model that supports and encourages higher quality and more coordinated…

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RITUXAN MAINTENANCE THERAPY

NATIONAL COMPREHENSIVE CANCER NETWORK®(NCCN®) STATUS1 NCCN CLINICAL PRACTICE GUIDELINES IN ONCOLOGY (NCCN GUIDELINES®) CATEGORY DESIGNATION1 Rituximab (RITUXAN®) is included in the NCCN Guidelines® with a category 1 designation for first-line maintenance therapy (one 375 mg/m2 dose every 2 months for 2 years) in follicular lymphoma patients initially presenting with high tumor burden1 Note: Category 1 designation is given…

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Florida Physician Assistant Update:

  • FLASCO
  • June 27, 2016
  • News
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Governor Scott signed HB 375 into law on Monday, March 28, 2016.  It relates to Physician Assistants (PA) and includes the following changes to the law: At renewal, PA must acknowledge that he/she has completed a minimum of ten (10) hours continuing medical education in the specialty practice in which the PA has prescriptive privileges….

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Vote Now! Dr. Lichter Nominated for Modern Healthcare’s List of 100 Most Influential People in Healthcare

  • FLASCO
  • June 22, 2016
  • News
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ASCO’s CEO, and FLASCO member, Dr. Allen Lichter, has again been nominated for Modern Healthcare magazine’s annual 100 Most Influential People in Healthcare recognition program. If you would like to vote for Dr. Lichter https://www.surveymonkey.com/r/BP3PSYP in celebration of his many contributions to ASCO and the cancer, please do so by this Friday, June 24. And feel…

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tesaro

New Q code for VARUBI (rolapitant) effective 7/1/2016

As you likely know, CMS has a National Coverage Determination policy outlining when to bill under Medicare Part B vs Part D when using oral anti-emetic therapies.  Under these policies, providers should bill under Part B only when specific criteria are met, including that the oral anti-emetics are used “as full replacement for the anti-emetic…

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New $10 Million Gainesville Cancer Center Delivers Comprehensive Care in Community Setting

  • FLASCO
  • June 14, 2016
  • News
  • No Comments

Florida Cancer Specialists & The Cancer Center at North Florida Regional Healthcare Partner to Provide Broad Range of Services Under One Roof. Florida Cancer Specialists & Research Institute announced the opening of its new location, the Gainesville Cancer Center, 6420 West Newberry Road – East Wing, Suite 100. The new state-of-the-art, comprehensive cancer facility, which…

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CMS Pushes Modifier -JW Requirement to 2017

CMS Pushes Modifier -JW Requirement to 2017 Source: Medicare Compliance Watch If CMS’ late April release of a change request requiring reporting of the previously optional modifier -JW (drug amount discarded/not administered to any patient) by July 1 seemed too sudden, the good news is many other providers—and the agency—agreed. Due to stakeholder concerns about…

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Available Clinical Trials at UF Health Cancer Center

UF Health Cancer Center has several clinical trials in process, below please find information about four trials that are currently accepting participants: ADU-CL-11 A Phase 1/2, Open-Label Safety and Efficacy Evaluation of CRS-207 in Combination With Epacadostat in Adults With Platinum-Resistant Ovarian, Fallopian, or Peritoneal Cancer. https://clinicaltrials.gov/ct2/show/NCT02575807?term=adu-cl-11&rank=1  ARGO A Phase III Randomized Placebo-Controlled Study Evaluating…

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Despite stakeholder outcry, CMS launches home health prior-authorization demo

Source: Modern Healthcare By Virgil Dickson Despite outcry from industry stakeholders, advocates and beneficiaries, the CMS is moving forward with a three-year demonstration in which beneficiaries from five states would need to get prior approval before they get home health services. The demonstration will launch in Florida, Illinois, Massachusetts, Michigan and Texas—states that are all tagged…

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Flasco

2016 ASCO Annual Meeting

  • FLASCO
  • June 9, 2016
  • News
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FLASCO Congratulates ASCO on a very successful and extremely educational Annual Meeting. Dr. Barry Berman, FLASCO Vice President, and Dr. Michael Diaz, FLASCO President officially represented FLASCO at the 2016 ASCO Annual Meeting.  Thank you to all of the FLASCO members and corporate members who took the time to stop by the ASCO State Affiliate…

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myriad genetics

Myriad Genetics Adds Breast Cancer Prognostic Dx to Portfolio Through Sividon Acquisition

  • FLASCO
  • June 2, 2016
  • News
  • No Comments

Myriad Genetics announced after the close of the market Tuesday the acquisition of Sividon Diagnostics in a deal that adds a breast cancer prognostic test to Myriad’s product portfolio and enhances its competitive position in oncology diagnostics. Myriad acquired Sividon for €35 million ($39 million) upfront and up to €15 million in payments based on…

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Florida Hospital Clinical Trial GL-ONC1-015: Phase 1b Study with GL-ONC1 Oncolytic Immunotherapy in Patients with Platinum-resistant or Refractory Ovarian Cancer

New Clinical Trials Available at FHCI: Ovarian Cancer and peritoneal carcinomatosis: GL-ONC1-015: This is an open-label, non-randomized Phase 1b study evaluating the safety and immunotherapeutic effect of GL-ONC1, an oncolytic vaccinia virus, in women diagnosed with platinum-resistant ovarian cancer and peritoneal carcinomatosis. GL-ONC1 is administered via an intraperitoneal catheter. https://clinicaltrials.gov/ct2/show/NCT02759588?term=GL-ONC1&rank=2   Clinical Trial Profile: Clinical…

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Congratulations is extended to Dr. Lucio Gordan who has accepted a term on Editorial Board of Journal of Clinical Oncology – Clinical Cancer Informatics

  • FLASCO
  • May 19, 2016
  • News
  • No Comments

Florida Cancer Specialists & Research Institute (FCS) is pleased to announce that Dr. Lucio Gordan, who practices at the Gainesville Cancer Center of FCS, has accepted a new term on the Editorial Board of the Journal of Clinical Oncology Clinical Cancer Informatics (JCO CCI). The Journal of Clinical Oncology, published by the American Society of…

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APP Best of ASCO Travel Awards – Apply Today!

  • FLASCO
  • May 19, 2016
  • News
  • No Comments

CALLING ALL ONCOLOGY FLASCO MEMBER ADVANCED PRACTICED PROVIDERS: Your FLASCO Board of Directors implemented an award to assist 2 Oncology PA or NP Providers to attend the Best of ASCO® for 2016.  FLASCO will award (2)two $500 Travel Awards.  The recipients will have the opportunity to attend either the 2016 Florida Hospital Best of ASCO®…

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Fellow’s ASTRO Travel Award Available -Apply Today!

  • FLASCO
  • May 19, 2016
  • Fellows
  • No Comments

Oncology Focused Trainees:   Award Opportunity!  Throughout the year FLASCO offers the opportunity for FLASCO member Fellows and Residents to submit applications for Travel Awards.  If you have plans to attend the ASTRO annual meeting, please take a moment to review the attached flyer for submission requirements and directions.  You may apply for more than…

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Three Florida Cancer Specialists’ Physicians Named Leukemia & Lymphoma Society’s Man/Woman of the Year

  • FLASCO
  • May 19, 2016
  • News
  • No Comments

Florida Cancer Specialists & Research Institute (FCS) is pleased to announce that Dr. Julia Cogburn, Dr. Vipul Patel and Dr. Meera Iyengar have all been named as Man/Woman of the Year 2016 by two regional Florida chapters of the Leukemia & Lymphoma Society (LLS). After a spirited fundraising campaign, these outstanding physicians and community leaders…

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Atezolizumab for Urothelial Carcinoma (Tecentriq, Genentech, Inc.)

  • FLASCO
  • May 19, 2016
  • Drugs
  • No Comments

U. S. Food and Drug Administration gave accelerated approval to atezolizumab injection (Tecentriq, Genentech, Inc.) for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.   Atezolizumab is a programmed…

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Nivolumab (Opdivo, Bristol-Myers Squibb) for Hodgkin Lymphoma

  • FLASCO
  • May 17, 2016
  • Drugs
  • No Comments

Click Here to Read the Corporate Press Release On May 17, 2016, the U. S. Food and Drug Administration granted accelerated approval to nivolumab (Opdivo, marketed by Bristol-Myers Squibb) for the treatment of patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin…

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FDA Approves Eisai’s LENVIMA® (lenvatinib) for the Treatment of Patients with Advanced Renal Cell Carcinoma in Combination with Everolimus Following Prior Anti-Angiogenic Therapy

  • FLASCO
  • May 16, 2016
  • Drugs
  • No Comments

Eisai Inc. announced that the U.S. Food and Drug Administration (FDA) approved LENVIMA® (lenvatinib), the company’s multiple receptor tyrosine kinase inhibitor, in combination with everolimus for the treatment of patients with advanced renal cell carcinoma (aRCC) who were previously treated with an anti-angiogenic therapy. This approval was based on the impressive results of the registration study (Study 205),…

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New Guidelines on Bladder Cancer Management: AUA/SUO

Source: Medscape New joint guidelines on the management of bladder cancer issued by the American Urological Association (AUA) and the Society of Urologic Oncology (SUO) validate many long-standing practices used in the management of superficial bladder cancer but also affirm the real benefits associated with newer technologies to better visualize bladder tumors. Most notabable among…

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astrazeneca

AstraZeneca Drug Wins Orphan Status in Thyroid Cancer

  • FLASCO
  • May 12, 2016
  • Drugs
  • No Comments

Source: Reuters An experimental AstraZeneca drug that failed last year as a treatment for a rare cancer of the eye has been awarded special “orphan” status in the United States for a type of thyroid cancer. The British drugmaker, which is relying on cancer treatments to revive its fortunes following a wave of patent expiries,…

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FDA Approved

TOLMAR wins FDA approval for ELIGARD to treat Advanced Prostate Cancer

  • FLASCO
  • May 12, 2016
  • Drugs
  • No Comments

TOLMAR Pharmaceuticals has secured from FDA for a label update for ELIGARD, indicated for the palliative treatment of advanced prostate cancer. Stability studies demonstrated that, prior to mixing, ELIGARD may be stored at room temperature (59 – 86° F) for up to 8 weeks following removal from refrigeration. ELIGARD is the only LHRH (luteinizing hormone…

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LabCorp Announces The Launch Of The Epi ProColon® Test For Colorectal Cancer Screening

  • FLASCO
  • May 12, 2016
  • Drugs
  • No Comments

Source: Business Wire Laboratory Corporation of America® Holdings (LabCorp®)  today announced the launch of Epi proColon®, a blood-based test for colorectal cancer screening that was approved on April 13, 2016 for clinical use by the U.S. Food and Drug Administration (FDA). Epi proColon® is the first FDA-approved DNA based blood test for colorectal cancer. The…

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Aetna Issues Positive Coverage Decision for NanoString’s Prosigna Breast Cancer Test

  • FLASCO
  • May 9, 2016
  • Drugs
  • No Comments

NanoString Technologies announced today that health insurer Aetna has added the Prosigna breast cancer test to its Tumor Markers Clinical Policy Bulletin, opening the door for test coverage. Prosigna is an in vitro diagnostic test that uses the PAM50 gene expression signature to assess prognosis and risk of disease recurrence for patients with specific types…

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pharmacyclics

U.S. FDA Expands IMBRUVICA (Ibrutinib) Label To Include Overall Survival Data In Previously Untreated CLL And New Indication For SLL Patients

  • FLASCO
  • May 9, 2016
  • Drugs
  • No Comments

U.S. FDA Expands IMBRUVICA (Ibrutinib) Label To Include Overall Survival Data In Previously Untreated Chronic Lymphocytic Leukemia (CLL) And New Indication For Small Lymphocytic Lymphoma (SLL) Patients U.S. Food and Drug Administration (FDA) updated the IMBRUVICA® (ibrutinib) Prescribing Information (PI) to include new data from two Phase 3 trials supporting its expanded use in patients with…

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foundation medicine

Foundation Medicine Announces Commercial Launch of Liquid Biopsy Assay, FoundationACT™

  • FLASCO
  • May 5, 2016
  • Drugs
  • No Comments

Foundation Medicine, Inc. announced the launch of FoundationACT (Assay for Circulating Tumor DNA), an analytically validated and accurate blood-based circulating tumor DNA (ctDNA) assay that provides patients and oncologists with a new option for comprehensive genomic profiling when a tissue biopsy is not feasible or when tissue is not available. By analyzing circulating tumor DNA isolated…

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CMS Proposes New Medicare Physician Payment System (Source: US Oncology)

On April 27, the Centers for Medicare and Medicaid Services released much-anticipated proposed regulations that will govern implementation of the new Medicare physician payment system that replaces the sustainable growth rate (SGR) formula repealed by Congress last year. The new system offers physicians two pathways for Medicare payment beginning in 2019: the Merit-Based Incentive Payment…

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CMS requests doc input on MACRA

  • FLASCO
  • May 5, 2016
  • News
  • No Comments

Source : Modern Healthcare CMS Acting Administrator Andy Slavitt struck a strongly conciliatory tone Wednesday at the second meeting of the committee created to evaluate payment models to be used in Medicare’s new reimbursement for physicians. Physician input is critical for the success of the Medicare Access and CHIP Reauthorization Act and the CMS wants…

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Exelixis Announces FDA Approval of CABOMETYX™ (Cabozantinib) Tablets for Patients with Advanced Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy

  • FLASCO
  • April 28, 2016
  • Drugs
  • No Comments

On April 25, 2016, the U. S. Food and Drug Administration approved cabozantinib (CABOMETYX, Exelixis, Inc.) for the treatment of advanced renal cell carcinoma in patients who have received prior anti-angiogenic therapy. The approval was based on a randomized study in which patients with advanced renal cell carcinoma who had received prior anti-angiogenic therapy received…

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ASCO Issues Clinical Guidelines On Adjuvant Chemotherapy For Early Breast Cancer.

Medscape reported that the American Society of Clinical Oncology (ASCO) “issued comprehensive clinical guidelines on adjuvant chemotherapy for early breast cancer and targeted adjuvant therapy for HER2-positive breast cancer.” The “guidelines are largely adapted from the 2015 Cancer Care Ontario (CCO) clinical practice guidelines, with some additional guidance from ASCO.” The recommendations were published online in…

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DISTINGUISHED SERVICE AWARD PRESENTED TO SARAH CEVALLOS: A TRUE CHAMPION AND ADVOCATE FOR PATIENT ACCESS TO CARE IN FLORIDA. 

  • FLASCO
  • April 18, 2016
  • News
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At the FLASCO Business of Oncology Summit on April 8th, on behalf of FLASCO, Thomas Marsland, MD presented an Distinguished Service Award to Sarah Cevallos, Chief Revenue Cycle Officer at Florida Cancer Specialists. Sarah was recognized for all of the time and talent she has dedicated to FLASCO’s Clinical Practice Commitee. She provides invaluable rapid updates…

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spectrum

FDA Grants Spectrum Pharmaceuticals Approval of EVOMELA™ (melphalan) for Injection

  • FLASCO
  • March 17, 2016
  • Drugs
  • No Comments

FDA Grants Spectrum Pharmaceuticals Approval of EVOMELA™ (melphalan) for Injection EVOMELA Received FDA Approval for Two Indications: High-Dose Conditioning Treatment for Multiple Myeloma (MM) Patients Undergoing Autologous Stem Cell Transplantation (ASCT) Palliative Treatment of Patients with MM Who Cannot Take Oral Therapy EVOMELA Admixture Solution is Stable for 4 Hours at Room Temperature in Addition…

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FDA Approves New Indication for Merck’s EMEND for Injection

  • FLASCO
  • February 18, 2016
  • Drugs
  • No Comments

FDA Approves New Indication for Merck’s EMEND for Injection Announcement Letter Press Release Prescribing Information Patient Product Information Merck  announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for single-dose EMEND® (fosaprepitant dimeglumine) for injection, Merck’s substance P/neurokinin-1 (NK1) receptor antagonist, in combination with other antiemetic medicines,…

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Puerto Rico Business of Oncology

  • FLASCO
  • February 15, 2016
  • Events
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A special thanks is extended to Dr. Gerardo Colon-Otero for all of his efforts in planning and implementing a very successful Business of Oncology Summit on February 6th in San Juan, Puerto Rico.   Thanks to all who attended and participated in this event. We would like to express our sincerest gratitude to our meeting sponsors: Level 1…

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Governor Rick Scott Declares February as Metastatic Breast Cancer Awareness Month

  • FLASCO
  • February 1, 2016
  • News
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  Governor Rick Scott Declares February as Metastatic Breast Cancer Awareness Month  TALLAHASSEE, Fla. – Metastatic breast cancer is the second leading cancer killer of women, and today Governor Rick Scott focuses attention on the complex disease by declaring February as Metastatic Breast Cancer Awareness Month in Florida. The Governor’s proclamation supports work by the Florida…

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FDA Approves First Drug to Show Survival Benefit in Liposarcoma

  • FLASCO
  • January 28, 2016
  • Drugs
  • No Comments

The U.S. Food and Drug Administration today approved Eisai’s Halaven (eribulin mesylate), a type of chemotherapy, for the treatment of liposarcoma (a specific type of soft tissue sarcoma) that cannot be removed by surgery (unresectable) or is advanced (metastatic). This treatment is approved for patients who received prior chemotherapy that contained an anthracycline drug. “Halaven is…

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Dako, an Agilent Technologies Company, Announces Expanded FDA Approval of Complementary Diagnostic Test to Include Melanoma

  • FLASCO
  • January 28, 2016
  • Drugs
  • No Comments

Dako, an Agilent Technologies Company, Announces Expanded FDA Approval of Complementary Diagnostic Test to Include Melanoma Dako, an Agilent Technologies company and a worldwide provider of cancer diagnostics, today announced that the U.S. Food and Drug Administration (FDA) has approved the expansion of the intended use of Dako PD-L1 IHC 28-8 pharmDx to include patients…

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