The FDA on September 26, 2023, approved BOSULIF® for pediatric patients 1 year of age and older with Chronic Phase (CP) Ph+ Chronic Myelogenous Leukemia (CML) that is newly diagnosed or resistant or intolerant to prior therapy. The FDA also approved a new capsule dosage form available in strengths of 50 mg and 100 mg. BOSULIF® is a product of Pfizer.
Category: FDA Approvals
TEMODAR® (Temozolomide)
The FDA on September 14, 2023, approved updated labeling for TEMODAR® 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 under this pilot program. The first drug that received approval under Project Renewal was XELODA® (Capecitabine). TEMODAR® is a product of Merck & Co., Inc..
HEPZATO® KIT (Melphalan for Injection/Hepatic Delivery System)
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.
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.