October 2023, Vol 14, No 5

Washington, DC—On September 6, 2023, the Association for Accessible Medicines (AAM), the leading trade association for generic and biosimilar manufacturers, released its 2023 U.S. Generic & Biosimilar Medicines Savings Report highlighting the value of generic and biosimilar medicines.

Crystal S. Denlinger, MD, FACP, has been named the new Chief Executive Officer (CEO) of the National Comprehensive Cancer Network.

Cancer clinical trials offer patients an opportunity to be treated with the most cutting-edge and promising therapies available, but the majority of patients who are offered these trials still are not signing up for them.

To better assist their oncology patients with getting into clinical trials, providers at the University of Florida Health Cancer Center, Gainesville, recently decided that they needed a new kind of navigator: an oncology clinical trial nurse navigator.

On August 14, 2023, the FDA approved melphalan hydrochloride for injection/Hepatic Delivery System (HDS; Hepzato Kit; Delcath Systems) as a liver-directed treatment for use in adults with uveal melanoma and unresectable hepatic metastases affecting <50% of the liver and no extrahepatic disease, or extrahepatic disease that is limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation.

On August 14, 2023, the FDA accelerated the approval of elranatamab-bcmm (Elrexfio; Pfizer), a bispecific B-cell maturation antigen–directed CD3 T-cell engager, for the treatment of adults with relapsed or refractory multiple myeloma who have received at least 4 previous lines of therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody.

On August 9, 2023, the FDA accelerated the approval of talquetamab-tgvs (Talvey; Janssen Biotech), a bispecific GPRC5D-directed CD3 T-cell engager, for the treatment of adults with relapsed or refractory multiple myeloma who have previously received at least 4 lines of therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody.

On August 11, 2023, the FDA accelerated the approval of the fixed-dose combination of niraparib and abiraterone acetate (Akeega; Janssen Biotech), with prednisone, for the treatment of adults with deleterious or suspected deleterious BRCA-mutated, castration-resistant prostate cancer, as determined by an FDA-approved test. The FDA granted this approval priority review.

On August 9, 2023, the FDA granted regular approval to pralsetinib (Gavreto; Genentech), a kinase inhibitor of wild-type RET and oncogenic RET fusions and mutations, for the treatment of adults with metastatic non–small cell lung cancer (NSCLC) and RET fusion–positive gene mutation, as detected by an FDA-approved test.

Improving clinical outcomes in the second line of treatment in patients with advanced biliary tract cancer remains an important goal, and researchers have been exploring various therapeutic targets, including HER2, an oncogene that creates a protein that encourages cell growth and accelerates the spread of cancers.