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FDA approves pembrolizumab for treatment of relapsed or refractory PMBCL

On June 13, 2018, the Food and Drug Administration granted accelerated approval to pembrolizumab (Keytruda, Merck) for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after two or more prior lines of therapy. Approval was based on data from 53 patients with relapsed or...

New indication for VENCLEXTA(R) (venetoclax tablets)

On June 8, 2018, VENCLEXTA® (venetoclax tablets) was approved by the US Food and Drug Administration (FDA) for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy. Genentech BioOncology® Access Solutions is your resource for access and...

UF Health

UF Health Cancer Center Navigator Referring Physician Resource

Connect with the UF Health Cancer Center Stay in the know. See what the UF Health Cancer Center is doing when you sign up to receive news and updates, information about current clinical trials, our magazine and our annual report. View full newsletter here. Subscribe to Cancer Center News here.

FDA approves bevacizumab for ovarian cancer and pembrolizumab for large B-cell lymphoma cancer

Bevacizumab for Ovarian Cancer On June 13, 2018, the Food and Drug Administration approved bevacizumab (Avastin®, Genentech, Inc.) for patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with carboplatin and paclitaxel, followed by single-agent bevacizumab, for stage III or IV disease after initial surgical resection. Approval was based on GOG-0218 (NCT00262847),...

FDA Approves New Treatment for Women with Advanced Ovarian Cancer After Initial Surgery

Today, the FDA granted approval to Avastin in combination with chemotherapy, followed by Avastin alone, for the treatment of women with advanced (stage III or IV) ovarian cancer after initial surgery. The Genentech press release including Important Safety Information is linked here. This approval marks an important milestone in ovarian cancer, as this is the...

FDA approves Fulphila (pegfilgrastim-jmdb) to help reduce the risk of infection during cancer treatment

The U.S. Food and Drug Administration today approved Fulphila (pegfilgrastim-jmdb) as the first biosimilar to Neulasta (pegfilgrastim) to decrease the chance of infection as suggested by febrile neutropenia (fever, often with other signs of infection, associated with an abnormally low number of infection-fighting white blood cells), in patients with non-myeloid (non-bone marrow) cancer who are...

Dr. Gerald Sokol Co-Authors Five Studies To Be Published / Presented at ASCO Annual Meeting

Hudson, FL – May 31, 2018 . . . Dr. Gerald Sokol, who practices at the Florida Cancer Specialists (FCS) location inHudson, FL is the co-author of five studies that will be published and/or presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting, which will be held in Chicago, IL, June 1 – 5, 2018. Expected to draw over...

FDA approves avatrombopag for thrombocytopenia in adults with chronic liver disease

On May 21, 2018, the Food and Drug Administration approved avatrombopag (Doptelet, AkaRx Inc.) for thrombocytopenia in adults with chronic liver disease scheduled to undergo a procedure. Approval was based on two international, identically designed, randomized, double-blind, placebo-controlled trials, ADAPT-1 and ADAPT-2. Patients (n=430) with chronic liver disease and thrombocytopenia received either avatrombopag (n=274) or...

taiho oncology

Taiho Oncology Announces Positive Topline Results from Pivotal Phase 3 Trial of LONSURF® (trifluridine/tipiracil) in Metastatic Gastric Cancer

PRINCETON, N.J., May 9, 2018 – Taiho Oncology, Inc. (U.S.), a subsidiary of Taiho Pharmaceutical Co., Ltd. (Japan), and Servier, announced today that the pivotal Phase 3 (TAGS) trial evaluating LONSURF ® (trifluridine and tipiracil) plus best supportive care (BSC) versus placebo plus BSC in patients with previously treated metastatic gastric cancer, met its primary...

Pfizer’s Biosimilar RETACRIT® (epoetin alfa-epbx) Approved by U.S. FDA

RETACRIT, the First U.S. Biosimilar Erythropoiesis-Stimulating Agent (ESA), Now Approved Across All Indications NEW YORK, N.Y., May 15 – Pfizer Inc. (NYSE:PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) approved RETACRIT® (epoetin alfa-epbx), a biosimilar to Epogen® and Procrit® (epoetin alfa)1, for all indications of the reference product. RETACRIT is now...

Florida Cancer Specialists & Research Institute Announces New Cancer Center in Ocala

Ocala, FL, May 17th, 2018… On May 16th, 2018, at 8:00 am, Florida Cancer Specialists (FCS) celebrated a new state-of-the-art cancer center that will be located on SW 48th Ave (off SR 200), Ocala, Florida 34474. With shovels in hand, FCS Executive Management, staff and Marion County physicians, Drs. Patrick Acevedo, Shilpa Oberoi, Vipul Patel, Craig Reynolds, Sachin Kamath and Mohammad Kamal, kicked off the transformation...

Florida Cancer Specialists Foundation Hosts Golf Classic

Fort Myers, FL – May 16th, 2018… The Florida Cancer Specialists (FCS) Foundation is proud to announce the inaugural 2018 Golf Classic, which will be held May 17th-18th, 2018, at the Heritage Palms Golf & Country Club located at 10420 Washingtonia Palm Way, Fort Myers, FL 33966. The event will be chaired by FCS Physician, Dr. Michael Raymond. The event will include...

Dr. Gail Wright Co-Authors Study on Combination Therapy for Patients with Advanced HER2-Negative Breast Cancer

New Port Richey, FL – May 14, 2018…… Dr. Gail Wright, who practices at Florida Cancer Specialists (FCS) locations in Hudson and New Port Richey was a co-author of a study manuscript recently published online in Breast Cancer Research and Treatment. The study investigated the use of ruxolitinib (an oral targeted therapy drug) or placebo in combination with capecitabine (a chemotherapy drug...

Florida Cancer Specialists & Research Institute Hosts Ribbon Cutting & Open House in Sun City

Sun City, FL, May 14th, 2018… Florida Cancer Specialists & Research Institute (FCS) physicians and staff welcomed patients, volunteers and local community leaders to a ribbon cutting ceremony and open house on April 25th, 2018, from4 – 6 p.m. to unveil the newly renovated of the new Sun City location. With nearly 100 attendees, the event celebrated the new and...

Florida Cancer Specialists’ Senior Physician Liaison Rhonda Webster Nominated for Leukemia & Lymphoma Society’s Woman of the Year

Nation’s Largest Independent Hematology and Oncology Practice Lends Support Orlando, FL – May 7, 2018. . . Florida Cancer Specialists & Research Institute (FCS) is pleased to announce that Central Florida Senior Physician Liaison, Rhonda Webster, has been nominated by the North and Central Florida chapter of the Leukemia & Lymphoma Society (LLS) as a candidate for the 2018 Woman...

Kymriah® (tisagenlecleucel), First-In-Class CAR-T Therapy From Novartis, Receives Second FDA Approval To Treat Appropriate R/R Patients With Large B-cell Lymphoma

(Novartis) May 1, 2018 – Novartis today announced the US Food and Drug Administration (FDA) has approved Kymriah® (tisagenlecleucel) suspension for intravenous infusion for its second indication – the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL),...

Florida Cancer Specialists & Research Institute Continues to Offer Trial Navigator for Local Clinical Research Trials in Hernando County

Brooksville, FL – April 26, 2018. . . Florida Cancer Specialists & Research Institute (FCS), the leading community oncology and hematology practice in the state, is pleased to announce the continued availability of a local Clinical Trial Navigator for its three Hernando County locations: Brooksville (7154 Medical Center Drive, Spring Hill, FL), County Line Road (11063 County Line Road, Spring Hill, FL)...

Florida Hospital Selects Regional Cancer Services Medical Director

Florida, April 23, 2018… Dr. Victor Melgen has been selected to serve as Regional Medical Director of the cancer services for the Florida Hospitals in Volusia and Flagler counties. In this role, Melgen will help guide the strategic vision and direction for the entire spectrum of oncology services for Florida Hospital DeLand in DeLand, Florida Hospital Fish Memorial in...

CMS Proposes Changes to Empower Patients and Reduce Administrative Burden

Changes in IPPS and LTCH PPS would advance price transparency and interoperability On April 24, CMS proposed changes to empower patients through better access to hospital price information, improve patients’ access to their electronic health records, and make it easier for providers to spend time with their patients. The proposed rule proposes updates to Medicare...

RITUXAN HYCELA: THE SAME ANTIBODY AS RITUXAN® (rituximab), DELIVERED SUBCUTANEOUSLY WITH HYALURONIDASE HUMAN IN 5-7 MINUTES

All patients must first receive at least one full dose of RITUXAN (rituximab) without experiencing severe adverse reactions before starting treatment with RITUXAN HYCELA due to the higher risk of hypersensitivity and other acute reactions during the first infusion Beginning therapy with RITUXAN allows management of hypersensitivity and other administration reactions by slowing or stopping...

FLASCO Prior Authorization Webinar

On April 17th, FLASCO’s Administrator Network hosted a webinar to discuss the challenges faced by practices when dealing with Prior Authorizations. We were joined by Risë Cleland, who presented Practical Strategies: The Challenge of Prior Authorization Burdens . Following Risë’s presentation, a panel representing different types of oncology practices in Florida, provided further insight on the topic. ...

Blue Cross Blue Shield Recognizes Florida Cancer Specialists & Research Institute for Quality in Value-Based Cancer Care

Brought to you by a 100% FLASCO Membership Partner Fort Myers, Florida, April 19th, 2018… Florida Cancer Specialists & Research Institute (FCS) has been recognized by Blue Cross Blue Shield as a Blue Distinction® Center for Cancer Care. FCS is the only community hematology and oncology practice in the state of Florida to be awarded this recognition. By...

astrazeneca

US FDA approves Tagrisso as 1st-line treatment for EGFR-mutated non-small cell lung cancer

1st-line use of Tagrisso offers potential new standard of care Tagrisso delivered unprecedented median progression-free survival of 18.9 months versus 10.2 months compared with current standard of care   AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Tagrisso (osimertinib) for the 1st-line treatment of patients with metastatic non-small cell lung cancer (NSCLC)...

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