FLASCO News

FDA

FDA approves new and updated indications for temozolomide under Project Renewal

On September 14, 2023, the Food and Drug Administration (FDA) approved updated labeling for temozolomide (Temodar, Merck) under Project Renewal, an Oncology Center of Excellence (OCE) initiative aimed at updating labeling information for older oncology drugs to ensure information is clinically meaningful and scientifically up-to-date. This is the second drug to receive a labeling update...

FDA

FDA approves melphalan as a liver-directed treatment for uveal melanoma

On August 14, 2023, the Food and Drug Administration approved HEPZATO KIT (melphalan for Injection/Hepatic Delivery System) containing melphalan (HEPZATO, Delcath Systems, Inc.) as a liver-directed treatment for adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone,...

FDA

FDA approves niraparib and abiraterone acetate plus prednisone for BRCA-mutated metastatic castration-resistant prostate cancer

On August 11, 2023, the Food and Drug Administration approved the fixed dose combination of niraparib and abiraterone acetate (Akeega, Janssen Biotech, Inc.), with prednisone, for adult patients with deleterious or suspected deleterious BRCA-mutated castration-resistant prostate cancer (mCRPC), as determined by an FDA-approved test. View full prescribing information for Akeega. Efficacy was evaluated in Cohort 1...

FDA

FDA grants accelerated approval to talquetamab-tgvs for relapsed or refractory multiple myeloma

On August 9, 2023, the Food and Drug Administration granted accelerated approval to talquetamab-tgvs (Talvey, Janssen Biotech, Inc.) adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. View full prescribing information for Talvey. Efficacy was...

FDA

FDA approves pralsetinib for non-small cell lung cancer with RET gene fusions

On August 9, 2023, the Food and Drug Administration granted regular approval to pralsetinib (Gavreto, Genentech, Inc.) for adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. Pralsetinib was previously granted accelerated approval for the NSCLC indication on Sept. 4, 2020, based on initial...

FDA

FDA approves trifluridine and tipiracil with bevacizumab for previously treated metastatic colorectal cancer

On August 2, 2023, the Food and Drug Administration approved trifluridine and tipiracil (LONSURF, Taiho Oncology, Inc.) with bevacizumab, for metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. FDA had previously approved single-agent LONSURF for this indication in September 2015....

FDA

FDA approves quizartinib for newly diagnosed acute myeloid leukemia

On July 20, 2023, the Food and Drug Administration approved quizartinib (Vanflyta, Daiichi Sankyo, Inc.) with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive, as detected by an...

FDA

FDA approves talazoparib with enzalutamide for HRR gene-mutated metastatic castration-resistant prostate cancer

On June 20, 2023, the Food and Drug Administration approved talazoparib (Talzenna, Pfizer, Inc.) with enzalutamide for homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). View full prescribing information for Talzenna Efficacy was evaluated in TALAPRO-2 (NCT03395197), a randomized, double-blind, placebo-controlled, multi-cohort trial enrolling 399 patients with HRR gene-mutated mCRPC. Patients were randomized...

© 2021 FLASCO | Premium Website Design by The HDG

FLASCO