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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....

FDA approves pembrolizumab for advanced esophageal squamous cell cancer

On July 30, 2019, the Food and Drug Administration approved pembrolizumab (KEYTRUDA, Merck) for patients with recurrent, locally advanced or metastatic, squamous cell carcinoma of the esophagus (ESCC) whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10), as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy....

bayer health

FDA approves darolutamide for non-metastatic castration-resistant prostate cancer

On July 30, 2019, the Food and Drug Administration approved darolutamide (NUBEQA, Bayer HealthCare Pharmaceuticals Inc.) for non-metastatic castration-resistant prostate cancer. Approval was based on ARAMIS (NCT02200614), a multicenter, double-blind, placebo-controlled clinical trial in 1,509 patients with non-metastatic castration resistant prostate cancer. Patients were randomized (2:1) to receive either 600 mg darolutamide orally twice daily (n=955)...

Sylvester Comprehensive Cancer Center Earns Prestigious NCI Designation

The NCI designation recognizes Sylvester as among the top cancer centers in the United States. Sylvester joins a highly select group as one of only two NCI-designated cancer centers in the state of Florida, and one of just 71 across the nation. Julio Frenk, M.D., M.P.H., Ph.D., president of the University of Miami, and Stephen D....

New Study Reveals Many Common Medications Increase Risk of Skin Cancer

Florida Cancer Specialists Oncologists Gerald Sokol, MD, MSc, FCP, Jorge Ayub, MD, Gail Wright, MD, FACP, FCCP and David Wenk, MD Co-Author New Research Study on Drug-Induced Photosensitivity Fort Myers, FL – July 19, 2019… Many common medications, including antibiotics, drugs used for high blood pressure and to lower cholesterol, even over-the-counter nonsteroidal anti-inflammatory drugs (NSAIDs),...

pfizer

FDA approves Ruxience (rituximab-pvvr), biosimilar to Rituxan (rituximab)

The U.S Food and Drug Administration (FDA) today approved Ruxience (rituximab-pvvr), a biosimilar to U.S.-licensed Rituxan (rituximab) for the treatment of adult patients with CD20-positive B-cell non-Hodgkin’s lymphoma (NHL) to be used as a single agent or in combination with chemotherapy, and CD20-positive Chronic Lymphocytic Leukemia (CLL) in combination with chemotherapy. Ruxience is also the...

FDA grants accelerated approval to selinexor for multiple myeloma

On July 3, 2019, the Food and Drug Administration granted accelerated approval to selinexor (XPOVIO, Karyopharm Therapeutics) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents,...

FDA approves selinexor for multiple myeloma

On July 3, 2019, the Food and Drug Administration granted accelerated approval to selinexor (XPOVIO, Karyopharm Therapeutics) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents,...

Change to the Herceptin HYLECTA™ (trastuzumab and hyaluronidase-oysk) J-code

Centers for Medicare & Medicaid Services (CMS) has made a change to the Herceptin HYLECTA™ (trastuzumab and hyaluronidase-oysk) J-code and has assigned a permanent J-code.  Effective July 1, 2019 the permanent J-code for Herceptin HYLECTA is J9356. If you have any questions, please reach out to me directly. You may also call Genentech Access Solutions at...

KEYTRUDA(R) (pembrolizumab): Additional Indication

Merck is pleased to announce that KEYTRUDA has been approved by the FDA for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and...

pfizer

FDA approves Zirabev (bevacizumab-bvzr), a biosimilar to Avastin (bevacizumab)

FDA approves Zirabev (bevacizumab-bvzr), a biosimilar to U.S.-licensed Avastin (bevacizumab).   A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an already-FDA approved biological product, known as a reference product. The biosimilar also must be shown to have no clinically meaningful differences in terms...

FLASCO Clinical Practice Committee – Making Strides for Patients

Recently, the FLASCO Clinical Practice Committee Chairman and Co-Chairmen, sent a letter to FL Blue expressing FLASCO’s  support for Gilotrif coverage. Last week Florida Blue provided the following response to FLASCO and we wanted to share this info with all members. “First of all thanks for reaching out to us and sharing feedback from FLASCO. ...

Recent update to the TECENTRIQ (atezolizumab) Prescribing Information

There was a recent update to the TECENTRIQ (atezolizumab) Prescribing Information that impacted the dosing regimens for certain indications. This change would allow for either the 840 mg or 1200 mg vials to be used for those indications. Please see below for the NDC information. Updated Prescribing Information Urothelial Carcinoma o   Administer TECENTRIQ as: 840...

FDA approves daratumumab for multiple myeloma ineligible for autologous stem cell transplant

On June 27, 2019, the Food and Drug Administration approved daratumumab (DARZALEX®, Janssen Biotech, Inc.) in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. Approval was based on MAIA (NCT02252172), an open-label, randomized (1:1), active-controlled phase 3 study, comparing dartumumab (16 mg/kg) in...

FDA Approves Amgen And Allergan’s KANJINTI™ (trastuzumab-anns),

Amgen (NASDAQ:AMGN) and Allergan plc (NYSE:AGN) announced that the U.S. Food and Drug Administration (FDA) has approved KANJINTI™ (trastuzumab-anns) for all approved indications of the reference product, Herceptin® (trastuzumab):  for the treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. “The FDA approval of KANJINTI is an important milestone for our biosimilars portfolio, providing an additional treatment...

FDA approves pembrolizumab for metastatic small cell lung cancer

On June 17, 2019, the Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA, Merck) for patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. Efficacy was investigated in 83 patients with SCLC who had disease progression on...

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