August 2023, Vol 14, No 4

On August 2, 2023, the FDA approved a new indication for trifluridine and tipiracil (Lonsurf; Taiho Oncology), in combination with bevacizumab (Avastin), for metastatic colorectal cancer previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy; an anti–vascular endothelial growth factor biologic therapy; and if RAS wild-type, an anti–epidermal growth factor receptor therapy.

On July 31, 2023, the FDA approved a new indication for dostarlimab-gxly (Jemperli; GlaxoSmithKline), a PD-1 inhibitor, in combination with carboplatin and paclitaxel, followed by single-agent dostarlimab, for primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR), as determined by an FDA-approved test, or microsatellite instability-high (MSI-H).

On July 20, 2023, the FDA approved quizartinib (Vanflyta; Daiichi Sankyo) with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy after consolidation chemotherapy, for the treatment of adults with newly diagnosed acute myeloid leukemia (AML) that is FLT3-internal tandem duplication (ITD)–positive, as detected by an FDA-approved test.

On June 20, 2023, the FDA approved a new indication for talazoparib (Talzenna; Pfizer), a poly (ADP-ribose) polymerase inhibitor, in combination with enzalutamide (Xtandi; Astellas) for homologous recombination repair (HRR) gene mutation–positive, metastatic castration-resistant prostate cancer. The FDA granted this application priority review.

Generic medicines are the backbone of the US prescription drug market, supplying more than 9 out of every 10 prescriptions. And the production of generic medicines overall has been remarkably stable—even during challenges such as the COVID-19 pandemic.

At the 10th Annual Cholangiocarcinoma Foundation Conference, Rachna Shroff, MD, MS, Chief, Gastrointestinal Medical Oncology, and Director, Clinical Trials Office, University of Arizona Cancer Center, Tucson, and Madhulika Eluri, MD, Hematology/Oncology Fellow, The University of Texas MD Anderson Cancer Center, Houston, debated whether chemotherapy remains the backbone for cholangiocarcinoma (CCA) treatment or if it is time to move away from this therapeutic strategy.