RSS FLASCO

  • FDA grants accelerated approval to pembrolizumab for HER2-positive gastric cancer May 6, 2021
    On May 5, 2021, the Food and Drug Administration granted accelerated approval to pembrolizumab (Keytruda, Merck & Co.) in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. Approval was based on the prespecified interim analysis of...
  • ASCO-ACCC Initiative to Increase Racial and Ethnic Diversity in Clinical Trials May 3, 2021
    The American Society of Clinical Oncology (ASCO) and the Association for Community Cancer Centers (ACCC) joined forces to ensure that cancer treatment trials better reflect the diversity of cancer populations. The collaboration is led by a Steering Group co-chaired by ASCO President, Lori J. Pierce, MD, FASTRO, FASCO, and ACCC Immediate Past President Randall A....
  • FDA Approves Immunotherapy for Endometrial Cancer with Specific Biomarker April 29, 2021
    Today, the U.S. Food and Drug Administration granted accelerated approval to Jemperli (dostarlimab) for treating patients with recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing chemotherapy and whose cancers have a specific genetic feature known as dMMR (which contain abnormalities that affect the proper repair of DNA...
  • COVID-19 Vaccination and Cancer: Frequently Asked Questions (English & Spanish) April 29, 2021
  • FDA grants accelerated approval to dostarlimab-gxly for dMMR endometrial cancer April 26, 2021
    On April 22, 2021, the Food and Drug Administration granted accelerated approval to dostarlimab-gxly (Jemperli, GlaxoSmithKline LLC) for adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following a prior  platinum-containing regimen. Efficacy was evaluated based on cohort (A1) in GARNET...
  • FDA grants accelerated approval to loncastuximab tesirine-lpyl for large B-cell lymphoma April 26, 2021
    On April 23, 2021, the Food and Drug Administration granted accelerated approval to loncastuximab tesirine-lpyl (Zynlonta, ADC Therapeutics SA), a CD19-directed antibody and alkylating agent conjugate, for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising...
  • FDA approves nivolumab in combination with chemotherapy for metastatic gastric cancer and esophageal adenocarcinoma April 16, 2021
    On April 16, 2021, the Food and Drug Administration approved nivolumab (Opdivo, Bristol-Myers Squibb Company) in combination with fluoropyrimidine- and platinum-containing chemotherapy for advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. Efficacy was evaluated in CHECKMATE-649 (NCT02872116), a randomized, multicenter, open-label trial that enrolled 1,581 patients with previously untreated advanced or metastatic...
  • FDA grants accelerated approval to sacituzumab govitecan for advanced urothelial cancer April 13, 2021
    On April 13, 2021, the Food and Drug Administration granted accelerated approval to sacituzumab govitecan (Trodelvy, Immunomedics Inc.) for patients with locally advanced or metastatic urothelial cancer (mUC) who previously received a platinum-containing chemotherapy and either a programmed death receptor-1 (PD-1) or a programmed death-ligand 1 (PD-L1) inhibitor. Efficacy and safety were evaluated in TROPHY...
  • FDA grants regular approval to sacituzumab govitecan for triple-negative breast cancer April 7, 2021
    On April 7, 2021, the Food and Drug Administration granted regular approval to sacituzumab govitecan (Trodelvy, Immunomedics Inc.) for patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. In April 2020, sacituzumab govitecan received accelerated approval...
  • FDA approves new dosing regimen for cetuximab April 7, 2021
    On April 6, 2021, the Food and Drug Administration approved a new dosage regimen of 500 mg/m2 as a 120-minute intravenous infusion every two weeks (Q2W) for cetuximab (Erbitux, ImClone LLC) for patients with K-Ras wild-type, EGFR-expressing colorectal cancer (mCRC) or squamous cell carcinoma of the head and neck (SCCHN). This approval provides for a biweekly...