News

FDA approves ramucirumab plus erlotinib for first-line metastatic NSCLC

  • Amanda Bridges
  • June 5, 2020
  • Drugs
  • No Comments

On May 29, 2020, the Food and Drug Administration approved ramucirumab (CYRAMZA®, Eli Lilly and Company) in combination with erlotinib for first-line treatment of metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations. Efficacy was evaluated in RELAY (NCT02411448), a multinational, randomized, double-blind, placebo-controlled,…

Genentech

FDA approves atezolizumab plus bevacizumab for unresectable hepatocellular carcinoma

  • Amanda Bridges
  • June 5, 2020
  • Drugs
  • No Comments

On May 29, 2020, the Food and Drug Administration approved atezolizumab in combination with bevacizumab (TECENTRIQ® and AVASTIN®, Genentech Inc.) for patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy. Efficacy was investigated in IMbrave150 (NCT03434379), a multicenter, international, open-label, randomized trial in patients with locally advanced unresectable or metastatic hepatocellular…

GlaxoSmithKline

Complimentary Webinar Series on Multiple Myeloma – GSK

  • Amanda Bridges
  • June 5, 2020
  • News
  • No Comments

You are invited to a 1 hour webinar, Current and Emerging Trends in Multiple Myeloma, presented by Dr. David Vesole, Myeloma Division and Director, Myeloma Research at the John Theurer Cancer Center at Hackensack. Several different dates and time to choose from in June.

ASCO Virtual Direct™ Highlights Jacksonville | Total Health Conferencing

  • Amanda Bridges
  • June 5, 2020
  • News
  • No Comments

Due to COVID-19, the ASCO Direct™ Highlights meeting will be virtual. The 2020 ASCO Direct™ Highlights meeting will offer the same benefit that you have come to depend on. The abstracts chosen for presentation and discussion reflect the foremost research and strategies in oncology that directly impact patient care. Expert faculty will place abstract findings into clinical context and discuss how the results may change the current standard of care. Our conferencing platform allows for presentation, discussion, analysis, and attendee participation.

Incyte Corporation Supports FLASCO as a FLASCO Diamond Corporate Member for 2020

  • Katrina Williams
  • June 2, 2020
  • News
  • No Comments

The FLASCO leadership is pleased to acknowledge Incyte Corporation as a FLASCO Diamond Corporate Member for 2020.  Please welcome and THANK them for their support, when they call or e-mail you. Incyte is grounded in the rigorous pursuit of scientific excellence and driven to advance medical research to discover, develop and deliver novel medicines that…

2020 Conquer Cancer – FLASCO Young Investigator Award Recipient

  • FLASCO
  • May 29, 2020
  • Fellows
  • No Comments

FLASCO is proud to announce the recipient of the 2020 Conquer Cancer -FLASCO Young Investigator Award Zaid H. Abdel Rahman, MD Mayo Clinic, Florida for his work “Evaluating the Impact of Philadelphia‐like Genetic Signature on Transplant Outcomes in Adults with B‐Lymphoblastic Leukemia/Lymphoma and Identification of Novel Fusion Partners”   Dr. Zaid Abdel Rahman is an…

Florida Cancer Specialists Participation at ASCO® Demonstrates Progress Made Through Clinical Research

  • Amanda Bridges
  • May 29, 2020
  • News
  • No Comments

Virtual gathering delivers the latest cancer science to the global community Fort Myers, Fla., May 27, 2020 ——Florida Cancer Specialists & Research Institute (FCS) physicians are the co-authors of 20 research studies that will be presented at the American Society of Clinical Oncology (ASCO®) ASCO20 Virtual Scientific Program being held May 29 – 31, 2020. As the largest gathering…

FDA approves nivolumab plus ipilimumab and chemotherapy for first-line treatment of metastatic NSCLC

  • Amanda Bridges
  • May 29, 2020
  • Drugs
  • No Comments

On May 26, 2020, the Food and Drug Administration approved the combination of nivolumab (OPDIVO, Bristol-Myers Squibb Co.) plus ipilimumab (YERVOY, Bristol-Myers Squibb Co.) and 2 cycles of platinum-doublet chemotherapy as first-line treatment for patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase…

FDA

FDA approves brigatinib for ALK-positive metastatic NSCLC

  • Amanda Bridges
  • May 26, 2020
  • Drugs
  • No Comments

On May 22, 2020, the Food and Drug Administration approved brigatinib (ALUNBRIG®, ARIAD Pharmaceuticals Inc.) for adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. Today, the FDA also approved the Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular, Inc.) as a companion diagnostic…

FDA approves ripretinib for advanced gastrointestinal stromal tumor

  • Amanda Bridges
  • May 20, 2020
  • Drugs
  • No Comments

On May 15, 2020, the Food and Drug Administration approved ripretinib (QINLOCK™, Deciphera Pharmaceuticals, LLC.), for adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. Efficacy was evaluated in INVICTUS (NCT03353753), an international, multi-center, randomized (2:1), double-blind, placebo-controlled trial in 129 patients with…

FDA grants accelerated approval to rucaparib for BRCA-mutated metastatic castration-resistant prostate cancer

  • Amanda Bridges
  • May 20, 2020
  • Drugs
  • No Comments

On May 15, 2020, the Food and Drug Administration granted accelerated approval to rucaparib (RUBRACA®, Clovis Oncology, Inc.) for patients with deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. Efficacy was investigated in TRITON2 (NCT02952534), an ongoing, multi-center, single arm clinical trial…

FDA approves nivolumab plus ipilimumab for first-line mNSCLC (PD-L1 tumor expression ≥1%)

  • Amanda Bridges
  • May 20, 2020
  • Drugs
  • No Comments

On May 15, 2020, the Food and Drug Administration approved the combination of nivolumab (OPDIVO®, Bristol-Myers Squibb Co.) plus ipilimumab (YERVOY®, Bristol-Myers Squibb Co.) as first-line treatment for patients with metastatic non-small cell lung cancer whose tumors express PD-L1(≥1%), as determined by an FDA-approved test, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma…

FDA grants accelerated approval to pomalidomide for Kaposi sarcoma

  • Amanda Bridges
  • May 20, 2020
  • Drugs
  • No Comments

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…

FCS patients report high satisfaction with care during Covid-19 pandemic

  • Amanda Bridges
  • May 20, 2020
  • News
  • No Comments

Cancer Patients Report High Satisfaction with Care During COVID-19 Pandemic Florida Cancer Specialists & Research Institute establishes protocols to protect patients with minimal disruption Fort Myers, Fla., May 19, 2020 —— Despite the many challenges of the current health care crisis, patients of  Florida Cancer Specialists & Research Institute (FCS) report high satisfaction with the oncology provider’s response…

AstraZeneca

FDA approves olaparib for HRR gene-mutated metastatic castration-resistant prostate cancer

  • Amanda Bridges
  • May 20, 2020
  • Drugs
  • No Comments

On May 19, 2020, the Food and Drug Administration approved olaparib (LYNPARZA®, AstraZeneca Pharmaceuticals, LP) for adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC), who have progressed following prior treatment with enzalutamide or abiraterone. Today, the FDA also approved FoundationOne® CDx (Foundation Medicine, Inc.)…

Takeda

New name for Takeda Oncology patient support program

  • Amanda Bridges
  • May 20, 2020
  • News
  • No Comments

Takeda Oncology has changed the name of their patient support program from Takeda Oncology 1Point to Takeda Oncology Here2Assist™ effective May 18, 2020. Please note that only the name is changing. Patients and providers will continue to have the same high level of comprehensive, personalized support. Please review the attached information for important details.

Genentech

FDA approves atezolizumab for first-line treatment of metastatic NSCLC with high PD-L1 expression

  • Amanda Bridges
  • May 19, 2020
  • Drugs
  • No Comments

On May 18, 2020, the Food and Drug Administration approved atezolizumab (TECENTRIQ®, Genentech Inc.) for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of…

FDA approves nivolumab plus ipilimumab for first-line mNSCLC (PD-L1 tumor expression ≥1%)

  • Amanda Bridges
  • May 15, 2020
  • Drugs
  • No Comments

On May 15, 2020, the Food and Drug Administration approved the combination of nivolumab (OPDIVO®, Bristol-Myers Squibb Co.) plus ipilimumab (YERVOY®, Bristol-Myers Squibb Co.) as first-line treatment for patients with metastatic non-small cell lung cancer whose tumors express PD-L1(≥1%), as determined by an FDA-approved test, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma…

Genentech Response to Patient Access Needs During COVID-19

  • Katrina Williams
  • May 15, 2020
  • News
  • No Comments

Hello, At Genentech, we recognize that the COVID-19 national public health emergency is causing personal and financial challenges for many patients and their families. Getting their prescribed Genentech medicines shouldn’t be one of those challenges.  Our highest priority is the health and safety of patients, and we believe it is critical for them to continue…

Eli Lilly and Company

FDA approves selpercatinib for lung and thyroid cancers with RET gene mutations or fusions

  • Katrina Williams
  • May 11, 2020
  • Drugs
  • No Comments

On May 8, 2020, the Food and Drug Administration granted accelerated approval to selpercatinib (RETEVMOTM, Eli Lilly and Company) for the following indications: Adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC); Adult and pediatric patients ≥12 years of age with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy;…

astrazeneca

FDA expanded the indication of olaparib to include its combination with bevacizumab

  • Katrina Williams
  • May 11, 2020
  • Drugs
  • No Comments

Food and Drug Administration expanded the indication of olaparib (LYNPARZA®, AstraZeneca Pharmaceuticals, LP) to include its combination with bevacizumab for first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination…

Florida Precision Oncology have opened their practice to offer Telehealth support

  • Amanda Bridges
  • May 11, 2020
  • News
  • No Comments

Drs. Mudad, Santos, Blanc and Jahanzeb of Florida Precision Oncology have opened their practice to Telehealth second opinions for your patients to avoid travel and receive expert advice from the comfort of their home while staying under your competent care. Contact 1-833-376-6265 (1-833-fponcol) for additional information.   If your practice is offering services you would…

Announcing the launch of the COVID-19 Emergency Food Assistance Program

  • Amanda Bridges
  • May 11, 2020
  • News
  • No Comments

Good afternoon Bristol Myers Squibb Foundation Friends, Partners and Colleagues: We are excited to be sharing with you the launch of the COVID-19 Emergency Food Assistance Program, designed to keep immunocompromised patients safe during the COVID-19 Pandemic. This comprehensive program brings together the unique offerings of Team Rubicon, a nonprofit organization that serves communities by mobilizing veterans…

Foundation Medicine

FDA grants accelerated approval to capmatinib for metastatic non-small cell lung cancer

  • Amanda Bridges
  • May 7, 2020
  • Drugs
  • No Comments

On May 6, 2020, the Food and Drug Administration granted accelerated approval to capmatinib (TABRECTATM, Novartis) for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test. Today, FDA also approved the FoundationOne CDx assay (Foundation…

Bayer

Bayer and NeoGenomics Launch the Test4TRKTM Program to Provide Genomic Cancer Testing at No Cost for People Living with Advanced Thyroid and Colorectal Cancers

  • Amanda Bridges
  • May 7, 2020
  • Drugs
  • No Comments

Bayer today announced the launch of Test4TRKTM program in collaboration with NeoGenomics, Inc. to offer genomic cancer testing for NTRK gene fusions at no cost for patients with RAI-refractory (RAI-R) differentiated thyroid carcinoma (DTC) and metastatic colorectal cancer (mCRC) with high microsatellite instability (MSI-H). NTRK gene fusions, which have been shown to drive tumor growth, are more commonly found in patients with MSI-H mCRC and RAI-R DTC and may play a role in disease management.

Florida Cancer Specialists & Research Institute Provides Hypofractionation Radiation Therapy – Advanced Treatment Option Offers Faster, More Efficient Radiation Therapy for Several Types of Cancers

  • Amanda Bridges
  • May 7, 2020
  • News
  • No Comments

Fort Myers, Fla., May 6, 2020  — Florida Cancer Specialists & Research Institute (FCS) offers an advanced radiation therapy option for several types of cancers, which can lead to faster and shorter rounds of radiation therapy for patients. Hypofractionated radiation is a treatment technique where the total dose of radiation is delivered in fewer treatment sessions and results…

Janssen | Johnson & Johnson

FDA approves daratumumab and hyaluronidase-fihj for multiple myeloma

  • Amanda Bridges
  • May 7, 2020
  • Drugs
  • No Comments

On May 1, 2020, the Food and Drug Administration approved daratumumab and hyaluronidase-fihj (DARZALEX FASPROTM, Janssen Biotech, Inc.) for adult patients with newly diagnosed or relapsed/refractory multiple myeloma. This new product allows for subcutaneous dosing of daratumumab. Daratumumab and hyaluronidase-fihj is approved for the following indications that intravenous daratumumab had previously received: in combination with…

Janssen | Johnson & Johnson

U.S. Food and Drug Administration Approves DARZALEX FASPROTM (daratumumab and hyaluronidase-fihj), a New Subcutaneous Formulation of Daratumumab in the Treatment of Patients with Multiple Myeloma

  • Amanda Bridges
  • May 5, 2020
  • Drugs
  • No Comments

Janssen, a Johnson and Johnson pharmaceutical company, is happy to share some exciting news – The FDA just approved DARZALEX FASPRO, a new subcutaneous formulation approved in four regimens across five indications, including newly diagnosed, transplant-ineligible and relapsed or refractory multiple myeloma. As you may know, today’s news is based on results from the COLUMBA…

RxVantage Virtual Meetings news update

  • Amanda Bridges
  • May 5, 2020
  • News
  • No Comments

In response to COVID-19, RxVantage adds Virtual Meetings to connect healthcare providers to life science experts   RxVantage, the digital education platform that makes it easy for practices to engage with life science companies, today announced the launch of RxVantage Virtual Meetings, a hassle-free digital solution designed to help providers reconnect with life science experts…

Guardant360

Updates regarding patient care during the COVID-19 Pandemic

  • Amanda Bridges
  • May 4, 2020
  • News
  • No Comments

The NCCN recently published the “Short-Term Recommendations for Non-Small Cell Lung Cancer Management During the COVID-19 Pandemic” and a recent piece was published in JNCCN.  These updates recommend the use of circulating tumor DNA (ctDNA) testing, like Guardant360, for patients progressing on oral therapy rather than having a patient in the hospital for a tissue biopsy. …

GlaxoSmithKline

FDA approves niraparib for first-line maintenance of advanced ovarian cancer

  • Amanda Bridges
  • May 1, 2020
  • Drugs
  • No Comments

On April 29, 2020, the Food and Drug Administration approved niraparib (ZEJULA, GlaxoSmithKline) for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy. Efficacy was investigated in PRIMA (NCT02655016), a double-blind, placebo-controlled trial that randomized 733…

Merck

FDA approves new dosing regimen for pembrolizumab

  • Amanda Bridges
  • April 30, 2020
  • Drugs
  • No Comments

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…

Janssen | Johnson & Johnson

COVID-19 Telehealth Policy Updates

  • Amanda Bridges
  • April 28, 2020
  • News
  • No Comments

In response to the COVID-19 pandemic, our healthcare system has had multiple policy changes, offering some flexibility to meet the needs of new patients and for those needing continuity in care.  One of these changes includes access and coverage of telehealth during the current public health emergency. The attached resource from the Center for Connected Health Policy https://www.cchpca.org may…

LLS Podcast Series for Professionals

Blood cancers are complex and multifaceted diseases, requiring knowledge by healthcare professionals on the array of diagnostic tests, treatment therapies, and survivorship issues. The LLS Podcast Series for Professionals provides up to date and accurate information on diagnosis, treatment and survivorship to educate HCPs treating patients with blood cancer. Listen in as we speak with experts…

Incyte

FDA grants accelerated approval to pemigatinib for cholangiocarcinoma with an FGFR2 rearrangement or fusion

  • Amanda Bridges
  • April 24, 2020
  • Drugs
  • No Comments

On April 17, 2020, the Food and Drug Administration granted accelerated approval to pemigatinib (PEMAZYRE™, Incyte Corporation) for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. The FDA also approved the FoundationOne® CDX…

Merck

Merck Sharp & Dohme Corp. (“Merck”), a subsidiary of Merck & Co., Inc., is pleased to announce that ONTRUZANT® (trastuzumab-dttb) for injection

  • Amanda Bridges
  • April 24, 2020
  • Drugs
  • No Comments

Merck Sharp & Dohme Corp. (“Merck”), a subsidiary of Merck & Co., Inc., is pleased to announce that ONTRUZANT® (trastuzumab-dttb) for injection, for intravenous use 21 mg/mL, a biosimilar* to Herceptin® (trastuzumab), is available through specialty distributors and wholesalers. Please contact your specialty distributor or wholesaler to confirm product availability. * Biosimilar means that the biological product is approved…

FDA

FDA grants accelerated approval to sacituzumab govitecan-hziy for metastatic triple negative breast cancer

  • Amanda Bridges
  • April 24, 2020
  • Drugs
  • No Comments

On April 22, 2020, the Food and Drug Administration granted accelerated approval to sacituzumab govitecan-hziy (TRODELVYTM, Immunomedics, Inc.) for adult patients with metastatic triple-negative breast cancer who received at least two prior therapies for metastatic disease. Efficacy was demonstrated in IMMU-132-01(NCT 01631552), a multicenter, single-arm, trial enrolling 108 patients with metastatic triple negative breast cancer…

Pharmacylics

FDA approves ibrutinib plus rituximab for chronic lymphocytic leukemia

  • Amanda Bridges
  • April 24, 2020
  • Drugs
  • No Comments

 On April 21, 2020, the Food and Drug Administration expanded the indication of ibrutinib (IMBRUVICA®, Pharmacyclics LLC) to include its combination with rituximab for the initial treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence….

OncLive

WEBCAST – Joseph Mikhael, MD and Kenneth Shain, MD, PhD on relapsed and refractory multiple myeloma

  • Katrina Williams
  • April 23, 2020
  • News
  • No Comments

Register for a Live Webcast scheduled for Thursday, April 30, 2020 (several times available)! Featuring key insights from Joseph Mikhael, MD and Kenneth Shain, MD, PhD on relapsed and refractory multiple myeloma, OncLive®’s new broadcast will provide you with updates regarding management with SARCLISA. CLICK HERE Shared by Sanofi Genzyme.

Seagen

Seagen: Introducing a New Treatment Regimen

  • Amanda Bridges
  • April 22, 2020
  • Drugs
  • No Comments

We are excited to announce the approval of TUKYSA by the U.S. Food and Drug Administration (FDA). TUKYSA is indicated in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the…

Janssen | Johnson & Johnson

Key Takeaways from J&J- The CARES Act and CMS Response to the COVID-19 Public Health Emergency Interim Final Rule

  • Amanda Bridges
  • April 21, 2020
  • News
  • No Comments

On March 27, 2020, Congress enacted the Coronavirus Aid, Relief, and Economic Security (CARES) Act, which makes a number of changes to support the ability of the health care system to respond to the COVID-19 crisis. The CARES Act also includes additional appropriations for the U.S. Department of Health and Human Services (HHS), much of which will be distributed to providers.

Janssen | Johnson & Johnson

Johnson & Johnson: The Road to a Vaccine

  • Amanda Bridges
  • April 17, 2020
  • News
  • No Comments

  At Johnson & Johnson we are uniting our resources and resolve to make headway against the COVID-19 pandemic.  We’re excited to share this story through The Road to a Vaccine, an educational LIVE video series that profiles the global scientific collaborative work underway to develop a potential vaccine. The new series launches this upcoming…

NCCN released recommendations for the use of hematopoietic growth factors during the COVID-19 pandemic

  • Katrina Williams
  • April 16, 2020
  • Drugs
  • No Comments

In response to the COVID-19 pandemic, National Comprehensive Cancer Network® (NCCN®) has released recommendations for the use of hematopoietic growth factors during this time. The recommendations have been posted on NCCN’s website, along with other COVID-19 Resources: Hematopoietic Growth Factors Recommendations NCCN COVID-19 Resources NCCN noted that for acute myeloid leukemia (AML) and myelodysplastic syndromes…

FDA

FDA approved mitomycin (JELMYTO™, UroGen Pharma) for adult patients with low-grade upper tract urothelial cancer (LG-UTUC)

  • Katrina Williams
  • April 16, 2020
  • Drugs
  • No Comments

Food and Drug Administration approved mitomycin (JELMYTO™, UroGen Pharma) for adult patients with low-grade upper tract urothelial cancer (LG-UTUC). More Information. April 15, 2020 https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mitomycin-low-grade-upper-tract-urothelial-cancer  Hematology/Oncology (Cancer) Approvals & Safety Notifications    https://www.fda.gov/drugs/resources-information-approved-drugs/hematologyoncology-cancer-approvals-safety-notifications

FDA approved selumetinib (KOSELUGO®, AstraZeneca) for pediatric patients

  • Katrina Williams
  • April 13, 2020
  • Drugs
  • No Comments

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…

FDA

Hematology/Oncology (Cancer) Approvals & Safety Notifications

  • Amanda Bridges
  • April 9, 2020
  • Drugs
  • No Comments

FDA does not issue approval announcements for every approval or drug label update that occurs in oncology and hematology. Please refer to Drugs@FDA for the latest approvals and prescribing information for specific products. 2020 Food and Drug Administration approved encorafenib (BRAFTOVI, Array BioPharma Inc.) in combination with cetuximab for the treatment of adult patients with metastatic colorectal cancer…

FDA

FDA approves encorafenib in combination with cetuximab for metastatic colorectal cancer with a BRAF V600E mutation

  • Amanda Bridges
  • April 9, 2020
  • Drugs
  • No Comments

On April 8, 2020, the Food and Drug Administration approved encorafenib (BRAFTOVI, Array BioPharma Inc.) in combination with cetuximab for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, detected by an FDA-approved test, after prior therapy. Efficacy was evaluated in a randomized, active-controlled, open-label, multicenter trial (BEACON CRC;…

U.S. Food and Drug Administration (FDA) Approves Reblozyl® (luspatercept-aamt), the First and Only Erythroid Maturation Agent, to Treat Anemia in Adults with Lower-Risk Myelodysplastic Syndromes (MDS)

  • Amanda Bridges
  • April 9, 2020
  • News
  • No Comments

The FDA approval marks the second indication for Reblozyl and the first new treatment option in over a decade for patients with MDS who require red blood cell (RBC) transfusions and have failed an erythropoiesis stimulating agent Reblozyl regulates late-stage RBC maturation to relieve patients from the burden of regular RBC transfusions PRINCETON, N.J. &…

Bristol Myer Squibb – what patient support programs are available for patients during this time?

  • Amanda Bridges
  • April 9, 2020
  • News
  • No Comments

We are committed to providing support to patients who need our medicines. The COVID-19 pandemic has created unprecedented financial challenges for patients and families. As more patients face difficult decisions in their daily lives, it is important to continue their treatments. We are proud to offer relief through our existing Bristol Myers Squibb patient support…

Bristol Myers Squibb Expands Patient Support Programs to Help Newly Uninsured Patients in the U.S. – Immediate Relief Available

  • Amanda Bridges
  • April 7, 2020
  • News
  • No Comments

PRINCETON, N.J. – April 7, 2020 – Bristol Myers Squibb (NYSE: BMY) today announced an expansion of its existing patient support programs to help eligible unemployed patients in the U.S. who have lost their health insurance due to the COVID-19 pandemic. The expanded program offers access to any branded Bristol Myers Squibb medicine for free,…

FDA approved luspatercept-aamt (REBLOZYL, Celgene Corporation) for the treatment of anemia

  • Katrina Williams
  • April 6, 2020
  • Drugs
  • No Comments

Food and Drug Administration approved luspatercept-aamt (REBLOZYL, Celgene Corporation) for the treatment of anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell (RBC) units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis…

Food and Drug Administration approved durvalumab (IMFINZI®, AstraZeneca) in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC)

  • Katrina Williams
  • March 30, 2020
  • Drugs
  • No Comments

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…

Sandoz Webinar

Webinar with Professor from Italy

  • Katrina Williams
  • March 24, 2020
  • News
  • No Comments

Sandoz will be hosting a webinar March 25th at 11am ET with a Professor/Hospital Director from Italy to facilitate sharing of knowledge and clinical experience regarding the COVID-19 pandemic. Details are listed below. . 

Please take three minutes of your time to answer these important questions:

  • Katrina Williams
  • March 24, 2020
  • News
  • No Comments

Dear Colleagues: Please take three minutes of your time to answer these important questions: https://www.surveymonkey.com/r/C8ZDYNW about the impact of the current COVID-19 pandemic on our practices, needs, and available resources. This survey has been prepared by the multi-state and international cardio-oncology collaborative network from the American College of Cardiology (ACC), American Society of Clinical Oncology (ASCO) and…

FDA approval for Neratinib to Treat HER2-Positive Metastatic Breast Cancer

  • Katrina Williams
  • March 23, 2020
  • Drugs
  • No Comments

Great news!  Puma Biotechnology received U.S. FDA approval for Neratinib to Treat HER2-Positive Metastatic Breast Cancer.  The sNDA approval was based on results of the Phase III NALA trial, a randomized controlled trial of neratinib plus capecitabine in patients with HER2-positive metastatic breast cancer who have received two or more prior anti-HER2-based regimens. Adam M….

Novartis Oncology

Novartis announces broad range of initiatives to respond to COVID-19 Pandemic; Creates USD 20 million global fund to support impacted communities

  • Amanda Bridges
  • March 20, 2020
  • News
  • No Comments

Novartis today announced a broad set of measures to support the global response to the COVID-19 pandemic. These measures include the creation of a global fund to support communities around the world impacted by the COVID-19 pandemic as well as the company’s decision to join two key cross-industry R&D initiatives. For more information click here.

Rx Vantage offers help during the COVID-19 pandemic

  • Katrina Williams
  • March 19, 2020
  • News
  • No Comments

RxVantage As the COVID-19 pandemic continues to evolve, we have fielded thousands of inquiries from our medical office community about updating and communicating protocols for industry reps and vendors. What we thought was a nice-to-have feature of our free service has become mission-critical for practice communication overnight. Given the volume of inquiries we are receiving,…

Heme Onc Call an option for off site consult for blood disorders

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….

FCS Expanding Cancer Care

  • Katrina Williams
  • February 21, 2020
  • News
  • No Comments

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)…

Additional Learning Opportunity During the Miami Winter Heme Meeting

  • Katrina Williams
  • February 21, 2020
  • News
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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…

Florida Cancer Specialists partners with Cedar to improve the patient financial experience

  • Katrina Williams
  • February 17, 2020
  • News
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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…

Taiho Oncology

Taiho Oncology Announcement

  • Katrina Williams
  • February 12, 2020
  • Drugs
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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…

ACCC Patient Assistance and Reimbursement

  • Amanda Bridges
  • January 30, 2020
  • News
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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…

FDA grants approval for TAZVERIK

  • Katrina Williams
  • January 29, 2020
  • Drugs
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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…

FDA approves Keytruda for treatment of patients with BCG

  • Katrina Williams
  • January 29, 2020
  • Drugs
  • No Comments

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…

FDA approves first treatment option specifically for patients with epithelioid sarcoma, a rare soft tissue cancer

  • Katrina Williams
  • January 24, 2020
  • Drugs
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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…

Janssen CarePathGeneral Resources

  • Katrina Williams
  • January 13, 2020
  • Advocacy
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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…

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