The FDA on August 14, 2023, approved HEPZATO® KIT 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, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. HEPZATO® is a product of Delcath Systems, Inc.
Category: FDA Approvals
ELREXFIO® (Elranatamab-bcmm)
The FDA on August 14, 2023, granted accelerated approval to ELREXFIO®, a bispecific B-Cell Maturation Antigen (BCMA)-directed CD3 T-cell engager, for 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. ELREXFIO® is a product of Pfizer, Inc.
AKEEGA® (Niraparib and Abiraterone Acetate)
The FDA on August 11, 2023, approved the fixed dose combination of AKEEGA® with prednisone, for adult patients with deleterious or suspected deleterious BRCA-mutated Castration-Resistant Prostate Cancer (mCRPC), as determined by an FDA-approved test. AKEEGA® is a product of Janssen Biotech, Inc.
TALVEY® (Talquetamab-tgvs)
The FDA on August 9, 2023, granted accelerated approval to TALVEY® for 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. TALVEY® is a product of Janssen Biotech, Inc.
GAVRETO® (Pralsetinib)
The FDA on August 9, 2023, granted regular approval to GAVRETO® for adult patients with metastatic REarranged during Transfection (RET) fusion-positive Non-Small Cell Lung Cancer (NSCLC) as detected by an FDA-approved test. GAVRETO® is a product of Genentech, Inc.
LONSURF® (Trifluridine and Tipiracil ) with Bevacizumab
The FDA on August 2, 2023, approved LONSURF® 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. LONSURF® is a product of Taiho Oncology, Inc.
JEMPERLI® (Dostarlimab-gxly)
The FDA on July 31, 2023, approved JEMPERLI® with Carboplatin and Paclitaxel, followed by single-agent JEMPERLI®, for primary advanced or recurrent Endometrial Cancer (EC) that is MisMatch Repair deficient (dMMR), as determined by an FDA-approved test, or MicroSatellite Instability-High (MSI-H). JEMPERLI® is a product of GlaxoSmithKline.
VANFLYTA® (Quizartinib)
The FDA on July 20, 2023, approved VANFLYTA® (Quizartinib) 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-approved test. VANFLYTA® is a product of Daiichi Sankyo, Inc.
TALZENNA® (Talazoparib) with Enzalutamide
The FDA on June 20, 2023, approved TALZENNA® with Enzalutamide for Homologous Recombination Repair (HRR) gene-mutated metastatic Castration-Resistant Prostate Cancer (mCRPC). TALZENNA® is a product of Pfizer, Inc.
COLUMVI® (Glofitamab-gxbm)
The FDA on June 15, 2023, granted accelerated approval to COLUMVI® for Relapsed or Refractory Diffuse Large B-Cell Lymphoma, not otherwise specified (DLBCL, NOS) or Large B-Cell Lymphoma (LBCL) arising from Follicular Lymphoma, after two or more lines of systemic therapy. COLUMVI® is a product of Genentech, Inc.