After 15 years of hospital-based heme/onc practice, Dr. Steve Fein started Heme Onc Call to service hospitals that have little or no heme/onc consultant availability. Dr. Fein has a deep-seated passion for helping patients with both nonmalignant blood disorders and blood cancers, and has come to realize that all hospitals need inpatient heme/onc specialty care….
Florida Cancer Specialists Expanding Cancer Care Treatment Services & Opening First of its KindDrug Development Unit with Sarah Cannon Research Institute in Central Florida FCS’s New Lake Mary Cancer Center & Sarah Cannon Research Institute Drug Development Unit to open this month Fort Myers, Fla., February 19, 2020 — Florida Cancer Specialists & Research Institute (FCS)…
On behalf of OncLive and Dr. Lonial of Winship Cancer Institute we would to invite you to participate in “Toxicity Management in Multiple Myeloma: An OncLive Scientific Interchange and Workshop”. This 3-hour meeting will be used to share your valuable insights, expert knowledge, and practical experience on management of toxicities associated with novel therapies in the treatment…
Personalized billing and payment platform will enable an improved financial experience for oncology patients across the growing FCS community-based provider network Fort Myers, Fla., February 10, 2020 — Florida Cancer Specialists & Research Institute (FCS) and Cedar, a patient engagement and payment technology platform, today announced that they are partnering to modernize the on-line payment experience…
On behalf of Taiho Oncology, Inc., we are pleased to inform you that a corporate press release, “Astex Pharmaceuticals announces U.S. Food and Drug Administration (FDA) acceptance for review of an NDA for the combination oral hypomethylating agent cedazuridine and decitabine (ASTX727 or oral C-DEC), for the treatment of MDS and CMML” has been issued…
IMPROVED FUNCTIONALITY & NAVIGATION! To Download your copy visit the ACCC site Today! Hot links on the “Table of Contents” allow you to go straight to the drug manufacturer’s patient assistance and reimbursement page OR click on a specific drug and go right to that drug’s patient assistance and reimbursement program. Plus, a “Table of…
Epizyme announces that U.S. Food and Drug Administration (FDA) has granted accelerated approval of TAZVERIK (tazemetostat) for the treatment of adults and pediatric patients age 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for resection, based on overall response rate and duration of response in a Phase 2 clinical trial. You…
Merck is pleased to announce that KEYTRUDA® (pembrolizumab) has been approved by the FDA for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. PD-L1 diagnostic testing is not…
Today, the U.S. Food and Drug Administration granted accelerated approval to Tazverik (tazemetostat) for the treatment of adults and pediatric patients aged 16 years and older with metastatic (when cancer cells spread to other parts of the body) or locally advanced (when cancer has grown outside the organ it started in, but has not yet…
https://www.janssencarepath.com/hcp/general-resources Access support to help navigate payer processes Know Your State Interactive Tool — Provides information on affordability options for your patients at the state level. Supporting Appropriate Payer Coverage Decisions Brochure — Helps you understand the information that payers may require for your patient’s coverage of medically necessary drug therapies. Prior Authorization Considerations Checklist — Presents general information…
Merck and FLASCO share the ASCO triple aim of matching the right patient to the right drug at the right time and believe this project can further that objective. Merck/AstraZeneca developed and shared a non-branded electronic resource that can be utilized by providers and patients, in both English and Spanish, that highlights why BRCA testing…
Today, the U.S. Food and Drug Administration approved Ayvakit (avapritinib) for the treatment of adults with unresectable (unable to be removed with surgery) or metastatic (when cancer cells spread to other parts of the body) gastrointestinal stromal tumor (GIST) – a type of tumor that occurs in the gastrointestinal tract, most commonly in the stomach…
Food and Drug Administration approved pembrolizumab (KEYTRUDA, Merck & Co. Inc.) for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. More Information. January 8, 2020 https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-bcg-unresponsive-high-risk-non-muscle-invasive-bladder-cancer Hematology/Oncology (Cancer)…
From the American Society of Clinical Oncology in cooperation with the Food and Drug Administration (FDA) and as a service to our members, ASCO will periodically distribute information about newly approved therapies for cancer patients. This helps FDA inform oncologists and professionals in oncology-related fields about recent approvals in a timely manner. Included in the…
Genentech is pleased to inform you that the Centers for Medicare & Medicaid Services (CMS) has assigned a permanent J-code for POLIVY™ (polatuzumab vedotin-piiq). POLIVY received FDA approval on June 10, 2019. Effective January 1, 2020, the J-code is J9309 (Injection, polatuzumab vedotin-piiq, 1 mg). The POLIVY J-code Announcement Flash Card, which details the new…
The PDF below contains sample coding information. Please see full Prescribing Information. Please feel free to contact the Genentech team with any questions or concerns about coding and billing. Contact a POLIVY Access Solutions Specialist at (888) 249-4918 Monday through Friday, 6 a.m. to 5 p.m. PT, or visit Genentech-Access.com/POLIVY. Correct coding is the responsibility of…
WHAT IS PADCEV? PADCEV (enfortumab vedotin-ejfv) is a prescription medicine used to treat adults with bladder cancer and cancers of the urinary tract (renal pelvis, ureter or urethra) that has spread or cannot be removed by surgery. PADCEV may be used if you have received an immunotherapy medicine and also received a chemotherapy-containing platinum medicine….
Starting January 1,2020, the Lonsurf Copay Assistance Program will transition to a new copay administrator. It will require some administrative actions on the part of whomever processes the scripts, both refills of existing scripts and new scripts. Currently enrolled, commercially insured eligible patients will move to the new program: Member ID # will remain…
FDA approved enzalutamide (XTANDI, Astellas Pharma Inc.) for patients with metastatic castration-sensitive prostate cancer (mCSPC). More Information. December 16, 2019 https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-enzalutamide-metastatic-castration-sensitive-prostate-cancer Hematology/Oncology (Cancer) Approvals & Safety Notifications https://www.fda.gov/drugs/resources-information-approved-drugs/hematologyoncology-cancer-approvals-safety-notifications
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…
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…
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 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…
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…
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…
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…
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…
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…
Today, the U.S. Food and Drug Administration approved Adakveo (crizanlizumab-tmca), a treatment to reduce the frequency of vaso-occlusive crisis – a common and painful complication of sickle cell disease that occurs when blood circulation is obstructed by sickled red blood cells – for patients age 16 years and older. Common side effects for patients taking…
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 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…
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…
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)…
Board approves increase in annual grant amount Sarasota, Fla., Oct. 17, 2019 — Since its inception in 2011, the Florida Cancer Specialists (FCS) Foundation has provided over $5.5 million in grants to help cancer patients in need. The FCS Foundation has awarded $1.16 million in grants year-to-date in 2019, surpassing the prior year’s total. The FCS…
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, 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.
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…
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…
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…
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…
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…
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…
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….
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….
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)…
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….
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),…
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…
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,…
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,…
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…
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…
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…
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. …
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…
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…
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…
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…
The FDA granted accelerated approval to Polivy™, Genentech’s fifth blood cancer medicine. Polivy (polatuzumab vedotin-piiq) is a first-of-its-kind anti-CD79b antibody-drug conjugate used in combination with bendamustine plus Rituxan (rituximab) for people with diffuse large B-cell lymphoma (DLBCL) whose disease returned after or did not respond to multiple treatment regimens. The Genentech press release including Important…
This year’s ASCO Annual was another great inspiration on so many levels! Congratulations are in order to the American Society of Clinical Oncology Planning Committee on the overwhelming success of the 2019 ASCO Annual Meeting, almost 40,000 people strong! The ASCO Annual Meeting brings together oncology professionals from around the world to discuss state-of-the-art treatment modalities, new…
Don Champlain Memorial Fund In Loving Memory of Don Champlain In lieu of flowers, donations can be made to the Don Champlain Memorial Fund, benefiting the Florida Cancer Specialists Foundation. Don had an incredible outlook and contagious positivity. His passion for his job was compelling and he leaves behind a legacy of love, dedication and…
Read Merck Press Release Here On June 10, 2019, the Food and Drug Administration approved pembrolizumab (KEYTRUDA, Merck) for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC). Pembrolizumab was approved for use in combination with platinum and fluorouracil (FU) for all patients and as a…
On June 10, 2019, the Food and Drug Administration granted accelerated approval to polatuzumab vedotin-piiq (POLIVY, Genentech, Inc.), a CD79b-directed antibody-drug conjugate indicated in combination with bendamustine and a rituximab product for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, after at least two prior therapies. Approval was based…
The Centers for Medicare and Medicaid Services (“CMS”) announced a final rule permitting Medicare Part B plans, including those administered through Medicare Advantage, to impose step therapy on new starts of Part B drugs. CMS noted that this utilization management tool will “ensure that Medicare beneficiaries pay less overall … for Part B drugs.” CMS…
On May 15, 2019, VENCLEXTA® (venetoclax tablets) was approved by the US Food and Drug Administration (FDA) for the first-line treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). VENCLEXTA is also approved in combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly-diagnosed acute myeloid leukemia…
New Medical Oncologist Joins in Palm Beach County Fort Myers, FL – June 4, 2019 . . . Florida Cancer Specialists & Research Institute (FCS) is pleased to announce that Medical Oncologist and Hematologist, Barry S. Berman, MD has joined joined the statewide practice and will be seeing patients in two offices, including West Palm Beach (1309…
The U.S. Food and Drug Administration today approved a new indication for the previously FDA-approved drug, Zerbaxa (ceftolozane and tazobactam) for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients 18 years and older. The FDA initially approved Zerbaxa in 2014to treat complicated intra-abdominal infections and for complicated urinary tract infections. “A…
To help foster a better understanding of biosimilars, Teva has created a resource center to house the latest information from their experts. Vist TevaBiosimilars.com to learn more
On May 16, 2019, the Food and Drug Administration approved dalteparin sodium (FRAGMIN®, Pfizer, Inc.) to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients 1 month of age and older. This is the first FDA-approved therapy to treat VTE in pediatric patients. Approval was based on evidence from two prospective, single-arm, multi-center…
On May 29, 2019, the Food and Drug Administration approved the addition of overall survival data in labeling for gilteritinib (XOSPATA, Astellas Pharma US, Inc.), indicated for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. Approval was based on the ADMIRAL trial…
EMD Serono is pleased to announce that on May 14, 2019 the U.S. Food and Drug Administration (FDA) approved BAVENCIO® (avelumab) Injection 20 mg/mL for a new indication, which is in combination with axitinib. BAVENCIO is co-developed and co-commercialized by EMD Serono and Pfizer Inc, and axitinib is commercialized by Pfizer Inc. The following information…
On May 28, 2019, the Food and Drug Administration approved lenalidomide (REVLIMID®, Celgene Corp.) in combination with a rituximab product for previously treated follicular lymphoma (FL) and previously treated marginal zone lymphoma (MZL). Approval was based on two clinical trials: AUGMENT (NCT01938001) and MAGNIFY (NCT01996865). In AUGMENT, 358 patients with relapsed or refractory FL or…
On May 24, 2019, the Food and Drug Administration approved ruxolitinib (JAKAFI®, Incyte Corporation) for steroid-refractory acute graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older. Approval was based on Study INCB 18424-271 (NCT02953678), an open-label, single-arm, multicenter study of ruxolitinib that enrolled 49 patients with steroid-refractory acute GVHD Grades 2 to…
On May 24, 2019, the Food and Drug Administration approved alpelisib (PIQRAY, Novartis Pharmaceuticals Corporation) in combination with fulvestrant for postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen….
The American Journal of Managed Care joined us at the 2019 FLASCO Spring Session and Business of Oncology Summit. Use the following link to check out the articles and videos featuring FLASCO’s educational sessions and interviews from FLASCO Members. https://www.ajmc.com/conferences/flasco-2019
On May 14, 2019, the Food and Drug Administration approved avelumab (BAVENCIO®, EMD Serono, Inc.) in combination with axitinib for first-line treatment of patients with advanced renal cell carcinoma (RCC). Approval was based on JAVELIN Renal 101 (NCT02684006), a randomized, multicenter, open-label trial of avelumab plus axitinib in 886 patients with untreated advanced RCC regardless…
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