The FDA on October 11, 2023, approved BRAFTOVI® with MEKTOVI® for adult patients with metastatic Non-Small Cell Lung Cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. Both BRAFTOVI® and MEKTOVI® are products of Array BioPharma Inc., a wholly owned subsidiary of Pfizer.
Author: RR
BOSULIF® (Bosutinib)
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.
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.