FLASCO / News

FDA approves new drug for treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis

FLASCO
October 8, 2018
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The US Food and Drug Administration (FDA) approved Tegsedi (inotersen), an antisense oligonucleotide (ASO) that inhibits the production of the transthyretin (TTR) protein (amyloid), for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR) in adults. This is the second FDA approved drug for hATTR. Onpattro (patisiran), was the first treatment approved for this…

FDA approves emicizumab-kxwh for hemophilia A with or without factor VIII inhibitors

FLASCO
October 5, 2018
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On October 4, 2018, the Food and Drug Administration approved emicizumab-kxwh injection (HEMLIBRA, Genentech, Inc.) for prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients (ages newborn and older) with hemophilia A (congenital factor VIII deficiency) with or without factor VIII (FVIII) inhibitors. Hemlibra was first approved in 2017 for…

FDA authorizes first next generation sequencing-based test to detect very low levels of remaining cancer cells in patients with acute lymphoblastic leukemia or multiple myeloma

FLASCO
October 1, 2018
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the U.S. Food and Drug Administration permitted marketing of ClonoSEQ assay, a next generation sequencing (NGS)-based test for minimal residual disease (MRD) in patients with acute lymphoblastic leukemia (ALL) or multiple myeloma. MRD is a measure of the amount of cancer cells remaining in a person’s bone marrow. “At the FDA, we’re continuing to maximize…

FDA APPROVES LIBTAYO® (CEMIPLIMAB-RWLC) AS FIRST AND ONLY TREATMENT FOR ADVANCED CUTANEOUS SQUAMOUS CELL CARCINOMA

FLASCO
October 1, 2018
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Libtayo is the third anti-PD-1 approved in the U.S. CSCC is the second most common skin cancer in the U.S. Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Libtayo® (cemiplimab-rwlc) for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for…

Thank you for all you do for the Oncology community, Dr. Santos!

Amanda Bridges
September 28, 2018
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FDA approves dacomitinib for metastatic non-small cell lung cancer

Amanda Bridges
September 28, 2018
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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…

New FDA Approval for the Expanded Use of IMBRUVICA® (ibrutinib)

Amanda Bridges
September 25, 2018
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AbbVie Announces IMBRUVICA® (ibrutinib) Plus Rituximab Approval by U.S. FDA as First Chemotherapy-Free Combination Treatment in Adults with Waldenström’s Macroglobulinemia, a Rare Type of Blood Cancer Milestone represents ninth FDA approval for IMBRUVICA in less than five years since its initial approval New approval of IMBRUVICA plus rituximab for Waldenström’s macroglobulinemia (WM) is supported by recent…

FDA granted regular approval to duvelisib (COPIKTRA, Verastem, Inc.) for adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)

FLASCO
September 25, 2018
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On Sept. 24, 2018, the Food and Drug Administration granted regular approval to duvelisib (COPIKTRA, Verastem, Inc.) for adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies. In addition, duvelisib received accelerated approval for adult patients with relapsed or refractory follicular lymphoma (FL)…

Verastem Oncology Receives FDA Approval of COPIKTRATM (duvelisib) capsules

Amanda Bridges
September 25, 2018
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BOSTON, MA – September 24, 2018 – Verastem, Inc. (Nasdaq:VSTM) (Verastem Oncology or the Company), focused on developing and commercializing medicines to improve the survival and quality of life of cancer patients, today announced that the U.S. Food and Drug Administration (FDA) has approved COPIKTRA™, an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first…

US FDA Approves New Treatment for Certain Hairy Cell Leukemia Patients

Amanda Bridges
September 18, 2018
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We are pleased to share that AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US Food and Drug Administration (FDA) has approved LUMOXITITM (moxetumomab pasudotox-tdfk), a first-in-class CD22-directed cytotoxin, for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who have received at least two…

FDA Grants Rare Pediatric Disease Designation to Cellectar Biosciences’ CLR 131 for the Treatment of Osteosarcoma

FLASCO
September 18, 2018
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Cellectar Biosciences, Inc. (Nasdaq: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, announces today that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) to CLR 131 for the treatment of osteosarcoma, a rare pediatric cancer. CLR 131 is…

FDA approves moxetumomab pasudotox-tdfk for hairy cell leukemia

FLASCO
September 13, 2018
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On Sept. 13, 2018, the Food and Drug Administration approved moxetumomab pasudotox-tdfk (LUMOXITI, AstraZeneca Pharmaceuticals LP), a CD22-directed cytotoxin indicated for adult patients with relapsed or refractory hairy cell leukemia (HCL) who received at least two prior systemic therapies, including treatment with a purine nucleoside analog (PNA). Approval was based on Study 1053 (NCT01829711) in…

FDA Approves New Treatment for the Maintenance Treatment of Opioid Dependence

FLASCO
September 10, 2018
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Today FDA approved Cassipa (buprenorphine and naloxone) sublingual film (applied under the tongue) for the maintenance treatment of opioid dependence. This action provides a new dosage strength (16 milligrams/4 milligrams) of buprenorphine and naloxone sublingual film, which is also approved in both brand name and generic versions and in various strengths. Cassipa was approved…

FDA Approves DELSTRIGO (Doravirine, Lamivudine, and Tenofovir Disoproxil Fumarate) for the Treatment of HIV-1 Infection in Adult Patients with no Antiretroviral Treatment History

FLASCO
September 6, 2018
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FDA Approves DELSTRIGO (Doravirine, Lamivudine, and Tenofovir Disoproxil Fumarate) for the Treatment of HIV-1 Infection in Adult Patients with no Antiretroviral Treatment History On August 30, 2018, the U.S. Food and Drug Administration (FDA) approved DELSTRIGO, a three-drug combination of doravirine, lamivudine, and tenofovir disoproxil fumarate (TDF), to be used as a complete regimen for…

Guardant Health Announces Medicare and Cigna Coverage for the Guardant360 Assay in Non-Small Cell Lung Cancer

Amanda Bridges
September 6, 2018
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The Guardant360® assay is now covered for all Medicare and Cigna beneficiaries with advanced NSCLC who meet certain clinical criteria. Guardant expects that these two coverage decisions will increase patient access to critical genomic information to better inform treatment. Medicare and Cigna both conducted rigorous reviews of the assay and evidence supporting its use. They evaluated dozens…

FDA Approves Ibrutinib Plus Rituximab for Waldenström’s Macroglobulinemia

FLASCO
August 29, 2018
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The U.S. Food and Drug Administration (FDA) has approved ibrutinib (Imbruvica) plus rituximab (Rituxan) for the treatment of adult patients with Waldenström’s macroglobulinemia (WM). With this approval, the ibrutinib prescribing information now includes combination use with rituximab, representing the first and only chemotherapy-free combination treatment specifically indicated for the disease. Ibrutinib— a first-in-class Bruton’s tyrosine kinase…

Roche receives FDA approval for cobas EGFR Mutation Test v2 as companion diagnostic with IRESSA (gefitinib) in first-line treatment of patients with non-small cell lung cancer (NSCLC)

FLASCO
August 24, 2018
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Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced approval from the U.S. Food and Drug Administration (FDA) for the cobas® EGFR Mutation Test v2 as a companion diagnostic test (CDx) with IRESSA®. A CDx test provides information that is essential for the safe and effective use of a corresponding therapeutic product. Clinical studies have demonstrated that…

Updates from a range of lung cancer studies

Amanda Bridges
August 21, 2018
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Prof Santos speaks to ecancer at BEST OF ASCO® 2018 MIAMI SYMPOSIUM about updates from key trials in lung cancer. He goes in to detail about the latest results of these studies across a range of therapies.

FDA grants regular approval for pembrolizumab in combination with chemotherapy for first-line treatment of metastatic nonsquamous NSCLC

FLASCO
August 21, 2018
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On August 20, 2018, the Food and Drug Administration approved pembrolizumab (KEYTRUDA®, Merck & Co., Inc.) in combination with pemetrexed and platinum as first-line treatment of patients with metastatic, non-squamous non-small cell lung cancer (NSqNSCLC), with no EGFR or ALK genomic tumor aberrations. Pembrolizumab was previously granted accelerated approval for this indication in May 2017…

Interested in Participating in a Feasibility Study?

FLASCO
August 17, 2018
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Sanofi Genzyme is currently looking for sites to participate in the feasibility for an upcoming Sanofi Genzyme study to assess a diagnostic protocol for individuals with unexplained splenomegaly and thrombocytopenia. This study will determine the prevalence of Gaucher Disease and Acid Sphingomyelinase Deficiency (Niemann-Pick A and B) among individuals with splenomegaly and thrombocytopenia who meet…

U.S. Food and Drug Administration Approves Opdivo® (nivolumab) as the First New Medication in Nearly 20 Years for Certain Patients with Previously Treated Small Cell Lung Cancer

FLASCO
August 17, 2018
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Opdivo is now the first Immuno-Oncology treatment approved for small cell lung cancer (SCLC) patients who received platinum-based chemotherapy and at least one other line of therapy Approval based on overall response rate and duration of response from the SCLC cohort of the Phase 1/2 CheckMate -032 trial 1 FRIDAY, AUGUST 17, 2018 6:59 AM EDT PRINCETON,…

FDA updates the prescribing information for Keytruda (pembrolizumab) and Tecentriq (atezolizumab) to require the use of an FDA-approved companion diagnostic test

FLASCO
August 17, 2018
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The FDA has updated the prescribing information for Keytruda (pembrolizumab) and Tecentriq (atezolizumab) to require the use of an FDA-approved companion diagnostic test to determine PD-L1 levels in tumor tissue from patients with locally advanced or metastatic urothelial cancer who are cisplatin-ineligible. Two different companion diagnostic tests were approved by the FDA, one for use…

FDA approves first generic version of EpiPen

FLASCO
August 16, 2018
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The U.S. Food and Drug Administration today approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions, including those that are life-threatening (anaphylaxis), in adults and pediatric patients who weigh more than 33 pounds. Teva Pharmaceuticals USA gained approval to market its generic epinephrine auto-injector in…

FDA approves lenvatinib for unresectable hepatocellular carcinoma

FLASCO
August 16, 2018
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On August 16, 2018, the Food and Drug Administration approved lenvatinib capsules (Lenvima, Eisai Inc.) for first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). Approval was based on an international, multicenter, randomized, open-label, non-inferiority trial (REFLECT; NCT01761266) conducted in 954 patients with previously untreated, metastatic or unresectable HCC. Patients were randomized (1:1) to receive…

Boehringer Ingelheim Patient Assistance Program

Amanda Bridges
August 14, 2018
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Boehringer Ingelheim is on a mission to improve lives around the world. We do this by developing innovative medicines and helping patients gain access to them – wherever they may be – and by supporting innovative programs that help ensure the health of individuals and communities in this and future generations.

FDA Approves Mogamulizumab-kpkc for Two Rare Types of Non-Hodgkin Lymphoma

FLASCO
August 9, 2018
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U.S. Food and Drug Administration approved mogamulizumab-kpkc (Poteligeo) injection for intravenous use for the treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy. This approval provides a new treatment option for patients with mycosis fungoides and is the first FDA approval of a drug specifically…

Florida Cancer Specialists & Research Institute Welcomes Dr. Simon Abi Aad

Amanda Bridges
August 7, 2018
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New Medical Oncologist Joins in Naples Naples, FL – August 6th, 2018. . . Florida Cancer Specialists & Research Institute (FCS), the largest community oncology/hematology practice in the state, is pleased to announce that medical oncologist Simon Abi Aad, MD, has joined the statewide practice and will be practicing at the Naples Napa Ridge office, located at 6360 Pine Ridge Road,…

FDA Approves Iobenguane I-131 for Rare Adrenal Gland Tumors

FLASCO
August 2, 2018
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On July 30, the U.S. Food and Drug Administration (FDA) approved iobenguane I-131 (Azedra) injection for adult and pediatric patients (12 years and older) with iobenguane scan–positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma (PPGL) who require systemic anticancer therapy. “Many patients with these ultra-rare cancers can be treated with surgery or local therapies, but there…

Shionogi & Co Ltd’s treatment for low blood-platelet count or thrombocytopenia in patients with chronic liver disease approved by FDA

FLASCO
August 1, 2018
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On July 31, 2018, the Food and Drug Administration approved lusutrombopag (Mulpleta, Shionogi Inc.) for thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure. Approval was based on two randomized, double-blind, placebo-controlled trials (L-PLUS 1 and L-PLUS 2, NCT02389621) involving 312 patients with chronic liver disease and…

FDA Discontinues Iclusig® REMS Program

FLASCO
August 1, 2018
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FLASCO has been notified that Takeda Oncology was recently advised by the U.S. Food and Drug Administration (FDA) that the REMS (Risk Evaluation and Mitigation Strategy) communication plan for ICLUSIG® (ponatinib) is no longer required. After a comprehensive assessment, FDA determined the ICLUSIG REMS communication plan had met its goals. As a result, the REMS…

FDA approves magnetic device system for guiding sentinel lymph node biopsies in certain patients with breast cancer

FLASCO
July 25, 2018
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The U.S. Food and Drug Administration approved a magnetic device system for guiding lymph node biopsies in patients with breast cancer undergoing mastectomy. The Magtrace and Sentimag Magnetic Localization System (Sentimag System) uses magnetic detection during sentinel lymph node biopsy procedures to identify specific lymph nodes, known as sentinel lymph nodes, for surgical removal. “Sentinel…

FDA approves Nivestym (filgrastim-aafi) a biosimilar to Neupogen (filgrastim)

FLASCO
July 23, 2018
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The FDA approved Nivestym (filgrastim-aafi), a biosimilar to Neupogen (filgrastim). This is the second approved biosimilar to Neupogen approved in the U.S. Click to read the Pfizer Press Release >> Nivestym Press Release Nivestym is approved for the same indications as Neupogen, and can be prescribed by a health care professional for: • patients…

FDA Releases Biosimilars Action Plan

FLASCO
July 20, 2018
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FDA released the Biosimilars Action Plan (BAP) to provide information about the key actions the agency is taking to encourage innovation and competition among biologics and the development of biosimilars. The BAP is focused on four key areas: improving the efficiency of the biosimilar and interchangeable product development and approval process; maximizing scientific and…

FDA approves first targeted treatment for patients with relapsed or refractory acute myeloid leukemia who have a certain genetic mutation

FLASCO
July 20, 2018
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The U.S. Food and Drug Administration today approved Tibsovo (ivosidenib) tablets for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. This is the first drug in its class (IDH1 inhibitors) and is approved for use with an FDA-approved companion diagnostic used to detect specific…

Cancer Groups Object to Medicare Proposals to Cut Part B

FLASCO
July 20, 2018
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Cancer Groups Object to Medicare Proposals to Cut Part B Source: Medscape – Kerry Dooley Young – July 19, 2018 Oncology groups are opposed to some of the proposals currently under consideration in the United States that are aimed at reducing the high cost of drugs. In recent years, a flood of new cancer drugs has…

XTANDI Significantly Extended Metastasis-Free Survival in Patients with Nonmetastatic CRPC

Amanda Bridges
July 18, 2018
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Astellas Pharma US, Inc. and Pfizer Inc. are pleased to announce that XTANDI is now indicated for the treatment of patients with CRPC.1 PROSPER was a multinational, randomized, double-blind, placebo-controlled phase 3 study of XTANDI + LHRH therapy† in patients with nonmetastatic CRPC who had progressed on LHRH therapy.†1,2 In PROSPER, 1401 patients with nonmetastatic…

FDA expands ribociclib indication in HR-positive, HER2-negative advanced or metastatic breast cancer

FLASCO
July 18, 2018
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On July 18, 2018, the Food and Drug Administration expanded the indication for ribociclib (Kisqali, Novartis Pharmaceuticals Corporation) in combination with an aromatase inhibitor for pre/perimenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy. FDA also approved ribociclib in combination with fulvestrant for postmenopausal women with HR-positive, HER2-negative advanced or…

FLASCO Donates $20,000 to Provide Scholarships for University of Puerto Rico School of Medicine First Year Students for a Summer Research Fellowship in Cancer Research at Mayo Clinic Cancer Center Jacksonville, Fl in Summer 2018.

FLASCO
July 17, 2018
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FLASCO donated $20,000 to provide 4 scholarships for University of Puerto Rico School of Medicine First Year Students a Summer Research Fellowship in Cancer Research at Mayo Clinic Cancer Center Jacksonville, Fl in Summer 2018. This program, originally funded by the NIH CCATS grant, consists of a week long course on research given by faculty…

FDA Approves enzalutamide for castration-resistant prostate cancer

FLASCO
July 16, 2018
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On July 13, 2018, the Food and Drug Administration approved enzalutamide (XTANDI, Astellas Pharma US, Inc.), for patients with castration-resistant prostate cancer (CRPC). This approval broadens the indicated patient population to include patients with both non-metastatic CRPC (NM-CRPC) and metastatic CRPC. Enzalutamide was previously approved for the treatment of patients with metastatic CRPC. Approval in…

FDA grants accelerated approval to ipilimumab for MSI-H or dMMR metastatic colorectal cancer

FLASCO
July 12, 2018
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On July 10, 2018, the Food and Drug Administration granted accelerated approval to ipilimumab (YERVOY®, Bristol-Myers Squibb Company Inc.) for use in combination with nivolumab for the treatment of patients 12 years of age and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with…

FDA limits the use of Tecentriq and Keytruda for some urothelial cancer patients

FLASCO
July 3, 2018
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FDA has limited the use of Tecentriq and Keytruda for patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing therapy. The Agency took this action on June 19, 2018, due to decreased survival associated with the use of Keytruda (pembrolizumab) or Tecentriq (atezolizumab) as single therapy (monotherapy) compared to platinum-based…

FDA Approves ZEMDRI (plazomicin) for the Treatment of Patients with Complicated Urinary Tract Infections Including Pyelonephritis

FLASCO
July 2, 2018
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On June 25, 2018, the U.S. Food and Drug Administration (FDA) approved ZEMDRI (plazomicin) for the treatment of patients 18 years of age or older with complicated urinary tract infections (cUTI) including pyelonephritis. As only limited clinical safety and efficacy data are available, reserve ZEMDRI for use in patients who have limited or no alternative…

FDA approves encorafenib and binimetinib in combination for unresectable or metastatic melanoma with BRAF mutations

FLASCO
June 27, 2018
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On June 27, 2018, the Food and Drug Administration approved encorafenib and binimetinib (BRAFTOVI and MEKTOVI, Array BioPharma Inc.) in combination for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. Approval was based on a randomized, active-controlled, open-label, multicenter trial (COLUMBUS; NCT01909453) in 577…

FLASCO Member Selected to be a Part of the ASCO 2018-2019 Leadership Development Program

Amanda Bridges
June 27, 2018
News
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Congratulations are in order for FLASCO member, Dr. Nathalie McKenzie, for being selected to be a part of the ASCO 2018-2019 Leadership Development Program. We are proud to have Dr. McKenzie represent FLASCO and the great state of Florida! Nathalie Dauphin McKenzie, MD, MSPH Florida Hospital Cancer Institute Nathalie Dauphin Mckenzie, MD, MSPH, serves as Director of…

FDA approves pembrolizumab for treatment of relapsed or refractory PMBCL

FLASCO
June 18, 2018
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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)

Amanda Bridges
June 15, 2018
Drugs
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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 Cancer Center Navigator Referring Physician Resource

Amanda Bridges
June 14, 2018
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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

Amanda Bridges
June 14, 2018
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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

Amanda Bridges
June 14, 2018
Drugs
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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

FLASCO
June 5, 2018
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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

Amanda Bridges
June 1, 2018
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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

FLASCO
May 24, 2018
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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 Announces Positive Topline Results from Pivotal Phase 3 Trial of LONSURF® (trifluridine/tipiracil) in Metastatic Gastric Cancer

Amanda Bridges
May 22, 2018
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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

Amanda Bridges
May 22, 2018
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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

Amanda Bridges
May 17, 2018
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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

Amanda Bridges
May 17, 2018
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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

Amanda Bridges
May 15, 2018
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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

Amanda Bridges
May 15, 2018
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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

Amanda Bridges
May 14, 2018
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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…

Genentech Access Solutions Medicare Beneficiary Identifier (MBI) Update

Amanda Bridges
May 7, 2018
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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

Amanda Bridges
May 2, 2018
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(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

Amanda Bridges
April 26, 2018
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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

Amanda Bridges
April 26, 2018
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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

Amanda Bridges
April 25, 2018
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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

Amanda Bridges
April 25, 2018
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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…

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

Amanda Bridges
April 19, 2018
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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…

FDA approves osimertinib for first-line treatment of metastatic NSCLC with most common EGFR mutations

FLASCO
April 19, 2018
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On April 18, 2018, the Food and Drug Administration approved osimertinib (Tagrisso, AstraZeneca Pharmaceuticals LP) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. Approval was based on a…

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

FLASCO
April 19, 2018
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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)…

FDA approves fostamatinib tablets for ITP

FLASCO
April 19, 2018
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On April 17, 2018, the Food and Drug Administration approved fostamatinib disodium hexahydrate tablets (TAVALISSE, Rigel Pharmaceuticals, Inc.) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. Approval was based on two identical, double-blind, placebo-controlled trials, FIT-1 (NCT02076399) and FIT-2 (NCT02076412)…

U.S. Food and Drug Administration Approves Opdivo® (nivolumab) + Yervoy® (ipilimumab) Combination as First-Line Treatment for Patients with Intermediate- and Poor-Risk Advanced Renal Cell Carcinoma

Amanda Bridges
April 17, 2018
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The Opdivo + low-dose Yervoy combination is the first and only treatment to show significantly superior overall survival versus sunitinib in intermediate- and poor-risk advanced renal cell carcinoma, including a survival benefit regardless of PD-L1 expression 1,2 Treatment with Opdivo + Yervoy delivered higher objective response rates, including more complete responses, than sunitinib 1,2 In the CheckMate -214 trial, which used dosing optimized for advanced renal…

FDA approves nivolumab plus ipilimumab combination for intermediate or poor-risk advanced renal cell carcinoma

FLASCO
April 16, 2018
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On April 16, 2018, the Food and Drug Administration granted approvals to nivolumab and ipilimumab (Opdivo and Yervoy, Bristol-Myers Squibb Co.) in combination for the treatment of intermediate or poor risk, previously untreated advanced renal cell carcinoma. The approvals were based on CheckMate 214 (NCT02231749), a randomized open-label trial. Patients with previously untreated advanced RCC…

FCS Foundation Honors Founding Chair Brad Prechtl and Announces New Board Leadership

Amanda Bridges
April 12, 2018
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Sarasota, FL – April 11th, 2018… The Florida Cancer Specialists (FCS) Foundation Board is pleased to announce new Board Co-Chairs, Dr. Michael Diaz, and FCS Board Member Jeffrey Phipps, Sr., as well as welcome new board member, FCS Physician Dr. Maen Hussein. Founding Chair, Brad Prechtl, was honored for his remarkable service to the Board and his contributions to the FCS…

FLASCO Fellow: Making a Difference in Patient’s Lives

Amanda Bridges
April 12, 2018
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As a senior fellow, one is blessed to have a light call schedule compared with that of our younger peers. Having paid our dues during residency and fellowship, we get the privilege of picking our call schedules and are required to cover just 4 weekends for the whole year. With 3 call weekends left on…

FDA approves everolimus for tuberous sclerosis complex-associated partial-onset seizures

FLASCO
April 11, 2018
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On April 10, 2018, the Food and Drug Administration approved everolimus tablets for oral suspension (Afinitor Disperz, Novartis Pharmaceuticals Corp.) for the adjunctive treatment of adult and pediatric patients aged 2 years and older with tuberous sclerosis complex (TSC)-associated partial-onset seizures. Everolimus is also approved for two other manifestations of TSC: TSC-associated subependymal giant cell…

FDA approves Clovis Oncology’s rucaparib for maintenance treatment of recurrent ovarian, fallopian tube, or primary peritoneal cancer

FLASCO
April 9, 2018
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On April 6, 2018, the Food and Drug Administration approved rucaparib (Rubraca®, Clovis Oncology Inc.), a poly ADP-ribose polymerase (PARP) inhibitor, for the maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Approval was based on ARIEL3 (NCT01968213), a randomized, double-blind,…

Charles Williams Jr., MD

FLASCO
March 30, 2018
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It is with saddened hearts that we share with you the passing of FLASCO member and beloved and respected oncologist, Charles Williams Jr., MD. Dr. Williams has been a part of Moffitt Cancer Center since it opened its doors back in 1986. Dr. Williams was a committed physician who exemplified their mission and touched the…

FDA granted accelerated approval to blinatumomab (Blincyto, Amgen Inc.) for the treatment of adult and pediatric patients with B-cell precursor acute lymphoblastic leukemia

FLASCO
March 30, 2018
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On March 29, 2018, the Food and Drug Administration granted accelerated approval to blinatumomab (Blincyto, Amgen Inc.) for the treatment of adult and pediatric patients with B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. Approval was based on the open…

FLORIDA CANCER SPECIALISTS FOUNDATION HOSTS RECORD-BREAKING POLO BRUNCH

Amanda Bridges
March 26, 2018
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Wellington, FL – March 26th, 2018… The Florida Cancer Specialists (FCS) Foundation is proud to announce the second annual Polo Brunch event, which was held on March 4th, 2018 at the International Polo Club Palm Beach, set an event record, raising $135,000, with all proceeds going to theFCS Foundation. This year, the event was chaired by Linda and Jeffrey…

Nilotinib Approved to Treat Pediatric Patients with Leukemia

FLASCO
March 26, 2018
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The FDA approved an expanded indication for nilotinib (Tasigna) as a first- and second-line treatment for pediatric patients 1 year and older with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP), according to a press release. Nilotinib is currently indicated to treat both adults and pediatric patients with newly-diagnosed Ph+ CML-CP. It is…

Dr. Janice Eakle Co-Authors Study on Triple Negative Breast Cancer

Amanda Bridges
March 22, 2018
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Lakewood Ranch, FL – March 22, 2018…… Dr. Janice Eakle, who practices at Florida Cancer Specialists (FCS) locations in Sarasota andLakewood Ranch, was a co-author of an article about a Phase II study that investigated the use of the drug enzalutamide in treating triple negative breast cancer (TNBC). Published in the Journal of Clinical Oncology in January 2018, the study examined the anti-tumor…

MSI Service Evaluation

FLASCO
March 22, 2018
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The Medicare Administrative Contractor (MAC) Satisfaction Indicator is the best way to share your opinion on their service directly to the Centers for Medicare & Medicaid Services. This survey should only take about 10 minutes of your time and helps them understand how they can better serve you. To take this survey, please CLICK HERE>>