Living with CLL Orlando, FL On January 14th, FLASCO held Living with CLL Patient Education Dinner Program in Orlando, FL with support from Pharmacyclics. This was an overwhelmingly successful event with wonderful reviews from all in attendance We would like to recognize the amazing speakers that donated their time and made this program a great success. Our sincerest gratitude…
FDA Expands Label For Pembrolizumab (Keytruda® Injection, Merck Sharp & Dohme Corp) Corporate Press Release Prescribing Information Medication Guide On December 18, 2015, the U. S. Food and Drug Administration (FDA) expanded the label to include the approval of pembrolizumab (Keytruda® Injection, Merck Sharp & Dohme Corp.) for the treatment of patients with unresectable or…
J Code for KEYTRUDA® (pembrolizumab) Available KEYTRUDA has been assigned a permanent HCPCS* code, effective January 1, 2016.1 HCPCS CODE DESCRIPTOR J9271 Injection, pembrolizumab, 1 mg For dates of service prior to January 1, 2016, use the appropriate unspecified HCPCS code to bill for KEYTRUDA. If you have questions about KEYTRUDA, please contact your…
The U.S. Food and Drug Administration today approved Vistogard (uridine triacetate) for the emergency treatment of adults and children who receive an overdose of the cancer treatment fluorouracil or capecitabine, or who develop certain severe or life-threatening toxicities within four days of receiving these cancer treatments. “Treating cancer requires not only selecting which drug may…
Click here to read corporate press release The U.S. Food and Drug Administration today approved Alecensa (alectinib) to treat people with advanced (metastatic) ALK-positive non-small cell lung cancer (NSCLC) whose disease has worsened after, or who could not tolerate treatment with, another therapy called Xalkori (crizotinib). Lung cancer is the leading cause of cancer death…
The U.S. Food and Drug Administration today approved Bridion (sugammadex) injection to reverse the effects of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide, which are used during certain types of surgery in adults. Rocuronium bromide and vecuronium bromide are neuromuscular blocking drugs that cause temporary paralysis by interfering with the transmission of nerve…
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) and Eagle Pharmaceuticals, Inc. (Nasdaq:EGRX) today announce that the U.S. Food and Drug Administration (FDA) has approved BENDEKA™, (bendamustine hydrochloride) injection, a liquid, low-volume (50 mL) and short-time 10-minute infusion formulation of bendamustine. BENDEKA is approved for the treatment of patients with chronic lymphocytic leukemia (CLL) and for the treatment…
The U.S. Food and Drug Administration approved Vonvendi, von Willebrand factor (Recombinant), for use in adults 18 years of age and older who have von Willebrand disease (VWD). Vonvendi is the first FDA-approved recombinant von Willebrand factor, and is approved for the on-demand (as needed) treatment and control of bleeding episodes in adults diagnosed with…
U.S. Food and Drug Administration cleared for marketing in the United States the first cooling cap to reduce hair loss (alopecia) in female breast cancer patients undergoing chemotherapy. Hair loss is a common side effect of certain types of chemotherapy, commonly associated with the treatment of breast cancer. Hair may fall out entirely, gradually, in…
Florida Cancer Affiliates is adding a new medical oncologist to its staff. Dr. Madhu K. Emani will be joining the practice November 2nd and will be caring for patients in FCA’s new Trinity treatment center. Experienced in the diagnosis and treatment of a variety of cancers, Dr. Emani has extensive expertise in both Medical Oncology…
Click here to read corporate press release U.S. Food and Drug Administration granted approval for Empliciti (elotuzumab) in combination with two other therapies to treat people with multiple myeloma who have received one to three prior medications. Multiple myeloma is a form of blood cancer that occurs in infection-fighting plasma cells (a type of white…
Click here for corporate release The U.S. Food and Drug Administration granted approval for Empliciti (elotuzumab) in combination with two other therapies to treat people with multiple myeloma who have received one to three prior medications. Multiple myeloma is a form of blood cancer that occurs in infection-fighting plasma cells (a type of white…
FDA approves Lilly’s Portrazza to treat advanced squamous non-small cell lung cancer The U.S. Food and Drug Administration today approved Portrazza (necitumumab) in combination with two forms of chemotherapy to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) who have not previously received medication specifically for treating their advanced lung cancer. Lung…
On November 23, 2015, the U. S. Food and Drug Administration approved nivolumab (Opdivo Injection, Bristol-Myers Squibb Company) 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 cancer who had received prior anti-angiogenic…
On November 20, 2015, the U.S. Food and Drug Administration approved ixazomib (NINLARO, Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited) in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. Ixazomib is the first approved oral proteasome inhibitor….
Novartis receives FDA regular approval for Tafinlar® + Mekinist® to treat aggressive form of melanoma based on long-term survival data The U. S. Food and Drug Administration granted accelerated approval to trametinib and dabrafenib for use in combination in the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K…
FDA Approves Gilead’s Single Tablet Regimen Genvoya® (Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide) for Treatment of HIV-1 Infection The U.S. Food and Drug Administration approved Genvoya (a fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of…
Brad Prechtl Named Florida Chair of CEOs Against Cancer Florida Cancer Specialists’ Chief Executive Leads the Cause in the Sunshine State Florida Cancer Specialists & Research Institute (FCS) is pleased to announce that CEO Brad Prechtl has been named Chair of the Florida Chapter of CEOs Against Cancer, a program of the American Cancer Society…
FDA Approves Genentech’s Cotellic™ (Cobimetinib) in Combination With Zelboraf® (Vemurafenib) in Advanced Melanoma Click here to read corporate press release The U.S. Food and Drug Administration approved Cotellic (cobimetinib) to be used in combination with vemurafenib to treat advanced melanoma that has spread to other parts of the body or can’t be removed by surgery,…
U.S. Food and Drug Administration expanded the approved use of Yervoy (ipilimumab) to include a new use as adjuvant therapy for patients with stage III melanoma, to lower the risk that the melanoma will return following surgery. Melanoma, the most aggressive type of skin cancer, is the leading cause of death from skin cancer. Melanoma…
The U.S. Food and Drug Administration today approved Imlygic (talimogene laherparepvec), the first FDA-approved oncolytic virus therapy, for the treatment of melanoma lesions in the skin and lymph nodes. “Melanoma is a serious disease that can advance and spread to other parts of the body, where it becomes difficult to treat,” said Karen Midthun, M.D.,…
Yondelis (trabectedin) Janssen The U.S. Food and Drug Administration today approved Yondelis (trabectedin), a chemotherapy, for the treatment of specific soft tissue sarcomas (STS) – liposarcoma and leiomyosarcoma – that cannot be removed by surgery (unresectable) or is advanced (metastatic). This treatment is approved for patients who previously received chemotherapy that contained anthracycline. According to…
The U.S. Food and Drug Administration today approved Onivyde (irinotecan liposome injection), in combination with fluorouracil and leucovorin, to treat patients with advanced (metastatic) pancreatic cancer who have been previously treated with gemcitabine-based chemotherapy. According to the National Cancer Institute, there will be 48,960 new cases of pancreatic cancer diagnosed in the U.S. in 2015,…
her-bca1 For your practice and your patients- Support for navigating the breast cancer journey Genentech provides an array of resources, tools, and in-office presentations designed specifically for patients with breast cancer and their healthcare teams For your patients 4HER PATIENT SUPPORT APP • A free app from Genentech that supports HER2+ breast cancer patients with information about breast cancer,…
Living with Myeloma Jacksonville, FL On October 15th, FLASCO held Living with Myeloma Patient Education Dinner Program in Jacksonville, FL with support from Takeda Oncology. This was an overwhelmingly successful event with over 50 patients and caregivers in attendance. We would like to recognize the amazing speakers that donated their time and added greatly to…
FLASCO appreciates our partnership with Moffitt Cancer Center. Congratulations on a Successful Conference!
FCS Welcomes Visjay Patel, MD Florida Cancer Specialists & Research Institute (FCS), the leading community oncology/hematology practice in the state, is pleased to announce that Vijay Patel, MD, has joined Florida Cancer Specialists and will be seeing patients at the FCS cancer center in Gainesville at 1147 NW 64th Terrace. Dr. Patel began practicing medical…
Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration (FDA) approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab), for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma. Read Corporate Press Release FDA Information: U. S. Food and Drug Administration granted accelerated approval to nivolumab (Opdivo Injection, Bristol-Myers Squibb Company) in…
AdvaMed CEO Ubl to lead PhRMA Source: Modern Healthcare By Adam Rubenfire September 25, 2015 Stephen Ubl, the lead lobbyist for the medical device industry, has been named president and CEO of the Pharmaceutical Research and Manufacturers of America. Ubl, 46, has led the Advanced Medical Technology Association, or AdvaMed, a medical device trade group,…
(BUSINESS WIRE)–Merck and Pfizer announced that the US Food and Drug Administration (FDA) has granted orphan drug designation for the investigational cancer immunotherapy avelumab* for the treatment of Merkel cell carcinoma (MCC), a rare and aggressive type of skin cancer.1,2 Each year, there are approximately 1,500 new cases of MCC diagnosed in the US.3 “We…
Welcome to ICD-10 CMS BLOG http://blog.cms.gov/2015/10/01/welcome-to-icd-10/ By Sean Cavanaugh, Deputy Administrator and Director, Center for Medicare Today, the U.S. health care system moves to the International Classification of Diseases, 10th Revision – ICD-10. We’ve tested and retested our systems in anticipation of this day, and we’re ready to accept properly coded ICD-10 claims. The change…
Bipartisan Lawmakers Send Letters to CMS Opposing Proposed Cuts to Radiation Therapy (Source: US Oncology) This week 228 bipartisan lawmakers in Congress sent three letters to the Centers for Medicare & Medicaid Services (CMS) asking the agency to reconsider proposed cuts to radiation oncology recommended in its 2016 Physician Fee Schedule (PFS) Proposed Rule. In…
Moffitt Cancer Center and Bristol-Myers Squibb Enter Into a Collaboration Agreement as Part of U.S. Immuno-Oncology Rare Population Malignancy Program NEW YORK & TAMPA, Fla., Sep 25, 2015 (BUSINESS WIRE) — Bristol-Myers Squibb Company and Moffitt Cancer Center today announced that they have entered into a collaboration agreement as part of Bristol-Myers Squibb’s Immuno-Oncology…
Courtesy Calls from First Coast Service Options First Coast has a new team (CERT Clinical Nurse Educators) making daily calls to providers across JN regarding CERT claims that have been audited by the CERT contractor and assessed with an error. Our goal in making one-to-one education calls is to provide outreach regarding specific education related…
CMS Proposes New Medicare Clinical Diagnostic Laboratory Tests Fee Schedule Proposed initiative would begin data collection process to set new payment rates WASHINGTON (September 25, 2015) – The Centers for Medicare & Medicaid Services (CMS) today announced its next step in implementing the Protecting Access to Medicare Act of 2014 (PAMA), requiring clinical laboratories…
FUTURE CONFERENCE DATES 2016 Winter Symposium & Recertification Review Buena Vista Palace Hotel & Spa Lake Buena Vista, FL February 10-14, 2016 2016 Summer Symposium Marriott Harbor Beach Resort Fort Lauderdale, FL August 3-7, 2016
Afatinib versus erlotinib as second-line treatment of patients with advanced squamous cell carcinoma of the lung (LUX-Lung 8): an open-label randomised controlled phase 3 trial The Lancet Oncology has recently published the overall survival (OS) data from a head-to-head Phase III clinical trial. The study evaluated a lung cancer treatment as a potential option for patients with…
FDA Approves New Oral Medication to Treat Patients with Advanced Colorectal Cancer The U.S. Food and Drug Administration today approved Taiho Oncology’s Lonsurf (a pill that combines two drugs, trifluridine and tipiracil) for patients with an advanced form of colorectal cancer who are no longer responding to other therapies. “The past decade has brought a new…
Health First Acquires Space Coast Cancer Centers A unit of Health First on Friday completed its acquisition of Space Coast Cancer Center, which had facilities in Titusville, Viera and Merritt Island. Former FLASCO President and Current FLASCO Board Member, Dr. Richard Levine, who founded and was president of the Space Coast Cancer Center, said the facilities…
ADCETRIS® (brentuximab vedotin) NEW INDICATION Dear Healthcare Professional: Seattle Genetics is pleased to announce FDA approval for use of ADCETRIS® (brentuximab vedotin) as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation treatment for patients with classical Hodgkin lymphoma (HL) at high risk of relapse or progression. The FDA decision was based on the positive results…
Florida Cancer Affiliates Expands Patient Access to Cutting-Edge Care with the Addition of Ferdy Santiago, MD Florida Cancer Affiliates (FCA), a community-based radiation oncology, medical oncology, and hematology practice announces that Ferdy Santiago, MD, has joined its practice and has begun seeing patients at its two centers at 8570 Granite Court, Fort Myers, Florida 33908…
Hematology and Oncology Consultants, PA Joins Florida Cancer Specialists & Research Institute Florida Cancer Specialists and Research Institute is pleased to announce that Hematology and Oncology Consultants, PA (HOC) is joining the practice, effective September 1, 2015. The alliance with HOC will add two clinical sites to the Florida Cancer Specialists’ network, extending services in…
FDA Approves Varubi (rolapitant) Treatment for Nausea and Vomiting from Chemotherapy The U.S. Food and Drug Administration approved Varubi (rolapitant) to prevent delayed phase chemotherapy-induced nausea and vomiting (emesis). Varubi is approved in adults in combination with other drugs (antiemetic agents) that prevent nausea and vomiting associated with initial and repeat courses of vomit-inducing (emetogenic…
Join the Effort to Stop Medicare Cuts to Radiation Oncology Contact Your Members of Congress Today! In its 2016 Physician Fee Schedule Proposed Rule, CMS is proposing overall Medicare cuts of three percent to radiation oncology services, and an even deeper six percent Medicare cut to freestanding radiation therapy centers. The proposed rule most…
Moffitt Cancer Center Researchers Develop Genetic Test that Predicts which Pancreatic Cancer Patients will Benefit from Surgery Pancreatic cancer, a highly lethal malignancy, is the fourth most common cause of cancer-related mortality in the United States. Approximately 25 percent of patients with early cancers undergo potential curative treatment with surgery and chemotherapy. Unfortunately, only about…
NCCN Publishes New Patient Education Resources for Kidney Cancer NCCN has published the NCCN Guidelines for Patients® and NCCN Quick Guide™ for Kidney Cancer, the newest addition to the library of NCCN Guidelines for Patients. Kidney Cancer is among the 10 most diagnosed cancers in both men and women in the United States, and it…
FDA approves Promacta (eltrombopag) to Treat Low Blood Platelet Count in Pediatric Patients The U.S. Food and Drug Administration today approved Promacta (eltrombopag) to treat low blood platelet count in pediatric patients – ages one year and older – with a rare blood disorder called chronic immune thrombocytopenic purpura (ITP). Promacta can be used in…
FLASCO Wants To Hear Your Step Therapy Story FLASCO is working with other health care organizations to encourage Florida lawmakers to address the negative impact of Step Therapy policies. We are currently looking for stories about barriers and challenges to navigating Step Therapy and fail-first policies to share with the media. If you have any…
Home Health Physician Certification Letter 05 06 2015 CMDs (Source: Contractor Medical Directors, Home Health/Hospice Medicare Contractors) Medicare has changed the physician documentation requirements for certification of home health care for dates of service effective January 1, 2015. While clinicians still need to certify benefit eligibility and a face to face encounter is still required,…
Myriad’s myPlan® Lung Cancer Myriad’s myPlan® Lung Cancer is a new RNA 46-gene expression signature based on cell cycle progression (CCP) genes —the genes that regulate cell division. myPlan Lung Cancer measures the expression levels of specific genes in combination with pathological stage to predict the 5-year risk of lung cancer death in patients with…
The Florida Department of Health is hosting a Cancer Research Symposium for the general public, designed to highlight and explain research funded through the Bankhead-Coley Cancer Research Program and the James and Esther King Biomedical Research Program. When: Friday, September 18, 2015 Where: University of Central Florida – College of Medicine, Orlando, Florida Click here to…
AKYNZEO® (netupitant/palonosetron) Florida Society of Clinical Oncology (FLASCO) News Flash In 2014, Eisai launched AKYNZEO (netupitant/palonosetron), a dual-action, single-dose oral antiemetic for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. AKYNZEO is an oral fixed combination of…
Dr. Rakesh Rohatgi Merges His Practice With Florida Cancer Specialists & Research Institute Tri-County Hematology & Oncology Joins FCS Fort Myers, FL – August 3, 2015 . . .Florida Cancer Specialists & Research Institute , is pleased to announce that Rakesh Rohatgi, MD, is merging his practice (Tri-County Hematology & Oncology) with Florida Cancer Specialists…
Dr. Shilpa Oberoi Joins Florida Cancer Specialists & Research Institute in Ocala Cancer Center Florida Cancer Specialists & Research Institute, is pleased to announce that Shilpa Oberoi, MD, has joined Florida Cancer Specialists and will be seeing patients at the FCS cancer center in Ocala, located at 1630 SE 18th Street, Suite 602, Ocala, FL 34471.Dr….
Florida Cancer Affiliates Acquires Radiation Oncology Facility in Panama City Panama City, Fla. (August 4, 2015) – Florida Cancer Affiliates (FCA), a practice in The US Oncology Network, acquired a radiation oncology facility in Panama City. The acquisition allows the medical oncologists of FCA to offer a full range of both medical oncology and…
Astellas Pharmaceuticals Start XTANDI at disease progression to metastatic CRPC for your patients on GnRH therapy*1. Click here to create your signature program.
Univita Termination with All Statewide Medicaid Managed Care Plans The Statewide Medicaid Managed Care (SMMC) plans will no longer contract with Univita for home health, durable medical equipment (DME) or intravenous therapy for their Medicaid members. Providers should continue providing services to enrollees during the transition period for any services that were previously authorized or…
FLASCO Member, Dr. Napoleon Santos joins Florida Cancer Specialists Florida Cancer Specialists & Research Institute and FLASCO are pleased to announce that Napoleon Santos, DO, has joined Florida Cancer Specialists and will be seeing patients at the FCS cancer center in West Palm Beach, located at 1309 N. Flagler Drive, West Palm Beach, FL 33401….
POMALYST (POMALIDOMIDE) LABEL UPDATE NOW AVAILABLE Celgene Corporation releases new phase 3 clinical trail information for Pomalyst. POMALYST (pomalidomide) + low-dose dexamethasone(dex) delivered significantly longer progression-free survival (PFS) vs high-dose dex in a phase 3 clinical trial. Pomalyst is a thalidomide analogue indicated, in combination with dexamethasone, for patients with multiple myeloma who have received…
AMGEN DISTRIBUTES IMPORTANT SAFETY UPDATES ON PROLIA® The FDA has required Amgen to distribute a safety update on Prolia® (denosumab) to professional societies as part of its REMS (Risk Evaluation and Mitigation Strategy) program. Prolia® is a RANK ligand (RANKL) inhibitor used to treat osteoporosis in postmenopausal women who have high risk of bone fracture….
NEW TEST: GENESTRAT (BIODESIX) Biodesix is pleased to announce the launch of GeneStrat, a liquid biopsy mutation test for genotyping tumors of NSCLC patients, is an exciting milestone for Biodesix. The combined diagnostic power of GeneStrat and VeriStrat will continue to help assist physicians in treating their patients by offering more information in a timely…
HCPCS C-CODE FOR BLINCYTO™ Onyx Pharmaceuticals, an Amgen subsidiary, announced the assignment of HCPCS C-code for BLINCYTO™ (blinatumomab) for Injection for intravenous use1. The Centers for Medicare and Medicaid Services (CMS) assigned a unique C-code for BLINCYTO which became effective on April 1, 2015. HCPCS Code BLINCYTO Long Descriptor Strength Effective Date C9449 Injection, blinatumomab,…
GAZYVA® – NCCN GUIDELINES® CATEGORY 1 DESIGNATION Obinutuzumab (GAZYVA®) + chlorambucil is included in the NCCN Guidelines® with a category 1 designation for first-line therapy in the following CLL patients without del(17p)*: – Age ≥70 years – Younger patients (age <70 years) with significant comorbidities – Frail patients with significant comorbidities Note: Category 1…
ROCHE RECEIVES FDA APPROVAL FOR COBAS® KRAS MUTATION TEST Roche announced that the U.S. Food and Drug Administration (FDA) has approved the cobas KRAS Mutation Test for diagnostic use. The real-time polymerase chain reaction (PCR) test is designed to identify KRAS mutations in tumor samples from patients with metastatic colorectal cancer and aid clinicians in…
FLUOROURACIL INJECTION USP (ADRUCIL) 5 G/100 ML (50 MG/ML) Teva Parenteral Medicines has issued a voluntary recall of eight lots of fluorouracil injection USP (Adrucil) 5 g/100 mL (50 mg/mL). The reason cited is the potential presence of particulate matter, namely, aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals. Individual 5…
OPDIVO NCCN GUIDELINES UPDATE Five days after the approval of OPDIVO for the treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, the National Comprehensive Cancer Network® (NCCN®) and their expert panel have made an interim update to the NCCN Guidelines® to include nivolumab (OPDIVO) as…
CMS Issued Guidance on Biosimilars Please review CMS Coverage of Biosimilars for more information. See new codes below: HCPCS Code Short Description Long Description Action Coverage Pricing Effective Date Q5101 Inj filgrastim g-csf biosim Injection, Filgrastim (G-CSF), Biosimilar, 1 microgram Add D 51 7/1/2015 Q9976 Inj Ferric Pyrophosphate Cit Injection, Ferric Pyrophosphate Citrate Solution,…
Ramucirumab mCRC On April 24, 2015, the U. S. Food and Drug Administration approved ramucirumab (CYRAMZA®, Eli Lilly and Company) for use in combination with FOLFIRI for the treatment of patients with metastatic colorectal cancer (mCRC) whose disease has progressed on a first line bevacizumab-, oxaliplatin- and fluoropyrimidine-containing regimen. Ramucirumab is a recombinant human monoclonal…
April 10th and 11th FLASCO held its Annual Meeting and Spring Session in Orlando at the Marriott World Center. We would like to express a special thanks to the FLASCO Program Committee for all of their hard work in planning the Spring General Session. There were great speakers with informative and captivating presentations. Thank you to…
A special thanks is extended to Dr. Thomas Marsland for all of his efforts in planning and implementing a very successful Business of Oncology Conference on April 10th. We had 240 attendees at this great conference. Thanks to all who attended and participated in this event. Additionally, a special thanks is extended to Denise Pierce,…
VeriStrat® Lung Cancer Journal: VeriStrat Proteomic Test Improves Overall Survival and Decreases Medical Costs for Patients with Advanced NSCLC BOULDER, Colo.—March 24, 2015— Biodesix, Inc. today announced the publication in the journal Lung Cancer of a pivotal paper demonstrating the economic implications to the US healthcare system of using VeriStrat® in guiding treatment of…
FDA Approved Dinutuximab On March 10, 2015, the U. S. Food and Drug Administration approved dinutuximab (Unituxin, United Therapeutics Corporation), in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy. Dinutuximab…
FDA Approves New Antifungal Drug Cresemba The FDA has approved Cresemba (isavuconazonium sulfate), a new antifungal drug product used to treat adults with invasive aspergillosis and invasive mucormycosis, rare but serious infections. Cresemba is marketed by Astellas Pharma US, Inc., based in Northbrook, Illinois. Aspergillosis is a fungal infection caused by Aspergillus species, and mucormycosis…
Zarxio (filgrastim-sndz) The FDA approved filgrastim-sndz (ZARXIO Injection, Sandoz Inc.), as a biosimilar to US-licensed Neupogen for the five indications for which US-licensed Neupogen is approved. The formulation of ZARXIO differs from that of US-licensed Neupogen in one inactive component. Sandoz, a subsidiary of Novartis, is the first company to get approval for a biosimilar,…
Mayo Clinic Hem/Onc Reviews 2015 Mayo Clinic would like to invite Fellows to submit a research abstract for the 16th Annual Mayo Clinic Hematology/Oncology Fellows’ Research Symposium as part of the 25th Annual Mayo Clinic Hematology/Oncology Reviews scheduled for July 29 – August 1, 2015 at The Ritz Carlton in Amelia Island, FL. Fellows are invited to submit…
Opdivo (nivolumab) The U.S. Food and Drug Administration today expanded the approved use of Opdivo (nivolumab) to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Lung cancer is the leading cause of cancer death in the United States, with an estimated 224,210 new diagnoses and…
ERWINAZE® (asparaginase Erwinia chrysanthemi) ERWINAZE® (asparaginase Erwinia chrysanthemi) is now FDA-approved to be administered intravenously (IV) in addition to the originally approved intramuscular (IM) route of administration. ERWINAZE for intramuscular injection (IM) or intravenous infusion (IV), 10,000 International Units/vial is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with…
Panobinostat (FARYDAK) Full prescribing information is available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205353s000lbl.pdf FARYDAK® (panobinostat) capsules On February 23, 2015, the U.S. Food and Drug Administration (FDA) granted accelerated approval to panobinostat (FARYDAK capsules, Novartis Pharmaceuticals) in combination with bortezomib and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior…
Revlimid The U.S. Food and Drug Administration has expanded the authorized use of Celgene Corp’s cancer drug Revlimid to include newly diagnosed patients with multiple myeloma. Previously the drug was only approved for patients who had received at least one previous therapy. Physicians in the United States have long been prescribing Revlimid for new patients…
Lenvima (lenvatinib) The U.S. Food and Drug Administration granted approval to Lenvima (lenvatinib) to treat patients with progressive, differentiated thyroid cancer (DTC) whose disease progressed despite receiving radioactive iodine therapy (radioactive iodine refractory disease). Please see full Prescribing Information.
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