FLASCO

FLASCO News

Guidelines for Lung Cancer Surveillance After Definitive Curative-Intent Therapy: ASCO Guideline

Edgardo S. Santos Castillero, M.D., FACP, Secretary of the Florida Society of Clinical Oncology (FLASCO), Founding Partner, Florida Precision Oncology R&C, FPO, a Division of 21st Century Oncology Thoracic and Head/Neck Cancer Programs, and Clinical Associate Professor at Charles E. Schmidt College of Medicine, Florida Atlantic University shared his appreciation of the opportunity provided by ASCO to him and his Co-Chairs...

New Standards/Guidelines to Dispense Oral Medications

Luis E. Raez, MD, FACP, FCCP, President of Florida Society of Clinical Oncology (FLASCO), Chief Scientific Officer & Medical Director of Memorial Cancer Institute, Memorial Health Care System and Clinical Professor of Medicine at the Herbert Wertheim College of Medicine, Florida International University participated in the Expert Panel created by the American Society of Clinical Oncology (ASCO) and the National Community Oncology Dispensing...

Info on accelerated approval for BRUKINSA

Please be aware NCCN has recently updated their Oncology Guidelines for Mantel Cell Leukemia (MCL) based on the accelerated approval for BRUKINSA. NCCN has provided BRUKINSA (zanubrutinib) in R/R MCL with a Level 2A Preferred evidence listing, comparable to other BTKi in the class. This is the link to the NCCN main website, https://www.nccn.org/professionals/physician_gls/default.aspx . 

Signatera Test to Assess Residual Disease

Signatera is a personalized, tumor informed circulating tumor DNA (ctDNA) test for molecular residual disease (MRD) assessment and surveillance monitoring. Signatera’s unique assay design is optimized to detect low levels of ctDNA with high sensitivity and specificity earlier than current colorectal cancer (CRC) standard of care. Signatera recently received Medicare draft coverage for certain forms...

Outcome of BRCA Survey Project

In July 2019, the FLASCO Board of Directors approved a Survey Initiative on BRCA testing with Merck, FLASCO Diamond Elite Member. All FLASCO Members who treat patients with breast/ovarian cancer, including APPs, were asked to complete the survey.  The goal of the project was to identify the needs in order to increase awareness and utilization...

Florida Health

January – 2020 – National Radon Action Month Webinar Series

The Florida Department of Health is a partner in conducting four free webinars during the month of January 2020.  The webinars are intended to raise awareness and knowledge of radon, the leading environmental cause of lung cancer in the United States.  You have the ability to affect change as it pertains to reducing radon-induced lung...

astrazeneca

CALQUENCE® (acalabrutinib) Receives US FDA Approval for New Indication

The US Food and Drug Administration (FDA) has approved CALQUENCE® (acalabrutinib) capsules for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). CALQUENCE for CLL was granted Breakthrough Therapy Designation by the FDA, and the approval was granted under the FDA’s Real Time Oncology Review (RTOR) and newly established...

FLASCO Advocating for Florida’s Cancer Patients Florida Blue Revises Tavalisse, Promacta, Nplate and Doptolet Coverage for Treatment of ITP

Prompted by a FLASCO Clinical Practice issue, Florida Blue has agreed to remove the requirement that the member has undergone splenectomy or has a contraindication to splenectomy from Florida Blue coverage policies for Tavalisse, Promacta, Nplate, and Doptelet.  The policy in question allowed coverage in the absence of splenectomy if the member has a contraindication...

BeiGene

Introducing BRUKINSA™ (zanubrutinib)—the new BTK inhibitor

FDA approves therapy to treat patients with relapsed and refractory mantle cell lymphoma supported by clinical trial results showing high response rate of tumor shrinkage For Immediate Release: November 14, 2019 Today, the U.S. Food and Drug Administration granted accelerated approval to Brukinsa (zanubrutinib) capsules for the treatment of adult patients with mantle cell lymphoma...

FDA Approved REBLOZYL® (luspatercept-aamt)

The US Food and Drug Administration has recently approved REBLOZYL® (luspatercept-aamt), the first and only erythroid maturation agent (EMA) indicated for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions. REBLOZYL is not indicated for use as a substitute for RBC transfusions in patients who require...

sandoz

NOW AVAILABLE: ZIEXTENZO (pegfilgrastim-bmez)

Sandoz Inc., a division of Novartis, is pleased to announce that Sandoz Inc. has received FDA approval for ZIEXTENZO (pegfilgrastim-bmez). As you may be aware, ZIEXTENZO, a biosimilar of Neulasta®, is a long-acting G-CSF indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs...

Upcoming Changes to Genentech Patient Foundation Enrollment Forms

As part of Genentech’s ongoing commitment to patient access and ensuring that patients and practices have a positive experience with Genentech, we constantly assess our processes to ensure they remain in the best interest of our practices and patients. Starting October 21st 2019, we will be launching a faster, more intuitive Genentech Patient Foundation enrollment...

Alexion Receives FDA Approval For ULTOMIRIS® (Ravulizumab-Cwvz) For Atypical Hemolytic Uremic Syndrome (AHUS)

October 18, 2019 at 7:45 PM EDT PDF Version – At 26 weeks, 54% of adults and 71% of children treated with ULTOMIRIS demonstrated Complete Thrombotic Microangiopathy (TMA) Response – BOSTON–(BUSINESS WIRE)–Oct. 18, 2019– Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced that the U.S. Food and Drug Administration (FDA) approved ULTOMIRIS® (ravulizumab-cwvz) for the treatment of atypical hemolytic uremic syndrome (aHUS)...

Genentech Access Solutions – Medicare Beneficiary Identifier (MBI) Update

Genentech Access Solutions – Medicare Beneficiary Identifier (MBI) Update This PDF provides important information about The Centers for Medicare & Medicaid (CMS) transition from the use of the Health Insurance Claim Number (HICN) to a Medicare Beneficiary Identifier (MBI) number, and how Genentech Access Solutions is addressing this conversion. Beginning January 1, 2020, Genentech Access...

Radon Education

Radon, is the number one leading cause of lung cancer among non-smokers in the U.S. Radon is a colorless, odorless, and tasteless gas that you would have no way of knowing you were being exposed to.

Director of Nursing Diane Cope Authors Study on Pain Management Considerations in Older Cancer Patients

Fort Myers, FLA., September 5, 2019 — Florida Cancer Specialists & Research Institute (FCS) Director of Nursing, Diane G. Cope, PhD, APRN, BC, AOCNP, is the author of a study that focuses on the complex considerations for managing pain in older cancer patients.  Entitled “Cancer Pain Management Considerations in Older Adults,” the article was published in May 2019 in...

CMS coverage changes regarding CAR T Therapies

Recently, the Centers for Medicare and Medicaid Services (CMS) posted two announcements which impacts payment and coverage  for Chimeric Antigen Receptor T-Cell (CAR T) Therapies.  This email will provide a brief summary of the Fiscal Year (FY) 2020 Inpatient Prospective Payment System (IPPS) Final Rule, and the National Coverage Determination (NCD) for CAR T cell therapy...

Celegene

Approval of a new product for myelofibrosis

Celgene is pleased to inform you of the US Food and Drug Administration’s recent approval of INREBIC® (fedratinib) capsules, a product from Celgene indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF). Attached please find an announcement of this recent approval. http://cloud.info-celgene.com/inrebicpro INDICATION...

Announcing a New Genentech Therapy for ROS1+ mNSCLC and NTRK+ Solid Tumors

Dear Healthcare Professional:  Genentech is excited to share the news of a new FDA approval. ROZLYTREK™ (entrectinib) is now FDA approved for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive. ROZLYTREK is also FDA approved for the treatment of adult and pediatric patients 12 years of age...

FDA approves entrectinib for NTRK solid tumors and ROS-1 NSCLC

On August 15, 2019, the Food and Drug Administration granted accelerated approval to entrectinib (ROZLYTREK, Genentech Inc.) for adults and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK)gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to...

U.S. FDA Approves INREBIC® (Fedratinib) as First New Treatment in Nearly a Decade for Patients With Myelofibrosis

The U.S. Food and Drug Administration (FDA) has approved INREBIC® (fedratinib) for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis.1 “The approval of INREBIC is another important milestone for Celgene and underscores our commitment to people living with blood cancers,” said Jay Backstrom, M.D., M.P.H., Chief...

FDA Approves First Therapy for Rare Joint Tumor

The U.S. Food and Drug Administration granted approval to Turalio (pexidartinib) capsules for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not responsive to improvement with surgery.   “TGCT can cause debilitating symptoms for patients such as pain, stiffness and limitation of movement....

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