RSS FLASCO

  • FDA approves atezolizumab for BRAF V600 unresectable or metastatic melanoma July 31, 2020
    On July 30, 2020, the Food and Drug Administration approved atezolizumab (Tecentriq, Genentech, Inc.) in combination with cobimetinib and vemurafenib for patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. Efficacy in combination with cobimetinib and vemurafenib was evaluated in a double-blind, randomized (1:1), placebo-controlled, multicenter trial (IMspire150, NCT02908672) in 514 patients. After a 28-day...
  • FDA Approves First Cell-Based Gene Therapy For Adult Patients with Relapsed or Refractory MCL July 30, 2020
    Today, the U.S. Food and Drug Administration approved Tecartus (brexucabtagene autoleucel), a cell-based gene therapy for treatment of adult patients diagnosed with mantle cell lymphoma (MCL) who have not responded to or who have relapsed following other kinds of treatment. Tecartus, a chimeric antigen receptor (CAR) T cell therapy, is the first cell-based gene therapy...
  • FDA Approves First Cell-Based Gene Therapy For Adult Patients with Relapsed or Refractory MCL July 27, 2020
    On July 24, 2020, the U.S. Food and Drug Administration approved Tecartus (brexucabtagene autoleucel), a cell-based gene therapy for treatment of adult patients diagnosed with mantle cell lymphoma (MCL) who have not responded to or who have relapsed following other kinds of treatment. Tecartus, a chimeric antigen receptor (CAR) T cell therapy, is the first...
  • Astex Pharmaceuticals, Taiho Oncology, and Otsuka Pharmaceutical announce FDA and Health Canada approval of INQOVI® (decitabine and cedazuridine) tablets, oral hypomethylating agent (HMA) therapy for intermediate and high-risk MDS and CMML July 20, 2020
    INQOVI is the first orally administered hypomethylating agent approved by the FDA and Health Canada INQOVI is a fixed-dose combination of the hypomethylating agent decitabine and the cytidine deaminase inhibitor cedazuridine, which prevents degradation of decitabine in the gastrointestinal tract and liver and enables its absorption via oral dosing Approval is based on the ASCERTAIN...
  • Announcing a New Genentech Therapy July 16, 2020
    Genentech is excited to share the news of the Food and Drug Administration (FDA) approval of PHESGO™ (pertuzumab, trastuzumab, and hyaluronidase-zzxf) injection, for subcutaneous use. PHESGO is a fixed-dose combination of pertuzumab and trastuzumab, HER2/neu receptor antagonists, and hyaluronidase, an endoglycosidase. Indications Early Breast Cancer PHESGO™ (pertuzumab, trastuzumab, and hyaluronidase-zzxf) is indicated for use in combination with...
  • FDA Approves New Therapy for Myelodysplastic Syndromes (MDS) That Can Be Taken at Home – Drug Information Update July 8, 2020
    Today, the U.S. Food and Drug Administration approved Inqovi (decitabine and cedazuridine) tablets for treatment of adult patients with myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML). This represents an important advance in treatment options for patients with MDS, a type of blood cancer, who previously needed to visit a health care facility to receive...
  • In Memory of Dr. Robert Cassell July 3, 2020
    With heavy hearts, FLASCO is saddened to announce the passing of longtime FLASCO member, Robert ‘Bob’ Cassell, MD, PhD.  Dr. Cassell passed away Tuesday, June 30th in Winter Haven, Florida, after battling COVID.  Dr. Cassell was a longtime member of FLASCO, serving on the Board of Directors for many years, and as FLASCO President from...
  • FDA approved avelumab 6/30/2020 July 2, 2020
    Food and Drug Administration approved avelumab (BAVENCIO, EMD Serono, Inc.) for maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. More Information. June 30, 2020 https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-avelumab-urothelial-carcinoma-maintenance-treatment Hematology/Oncology (Cancer) Approvals & Safety Notifications https://www.fda.gov/drugs/resources-information-approved-drugs/hematologyoncology-cancer-approvals-safety-notifications
  • FDA approves combination of pertuzumab, trastuzumab, and hyaluronidase-zzxf for HER2-positive breast cancer July 2, 2020
    On June 29, 2020, the Food and Drug Administration approved a new fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase–zzxf (PHESGO®, Genentech, Inc.) for subcutaneous injection for the following indications: Use in combination with chemotherapy as: • neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm...
  • FDA Approves First-Line Immunotherapy for Patients with MSI-H/dMMR Metastatic Colorectal Cancer – Drug Information Update June 30, 2020
    The U.S. Food and Drug Administration approved Keytruda (pembrolizumab) for intravenous injection for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. This marks the first immunotherapy approved for this patient population as a first-line treatment and which is administered to patients without also giving...