Articles related to FDA

Another win for Merck and Keytruda, as the FDA granted accelerated approval to pembrolizumab in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 based on PFS. The FDA also approved a companion diagnostic, PD-L1 IHC 22C3 pharmDx.

In this editorial from The New England Journal of Medicine, the authors criticize the country’s leadership on its response to the COVID-19 pandemic, presenting several pieces of evidence to reinforce their claims. From politicizing the Food and Drug Administration (FDA) to undercutting trust in science and government, the leaders of our nation are “causing damage that will certainly outlast them.”

The approval of capmatinib and its companion diagnostic is the first of its kind for this specific diagnosis, using next-generation sequencing to perform comprehensive genomic profiling of solid tumors. It now has FDA approval for 21 different agents.

Based on monotherapy data from an open-label, multi-center, single-arm study of 105 adults with platinum-sensitive and platinum-resistant SCLC that progressed after platinum-based chemotherapy, the FDA granted accelerated approval to lurbinectedin (Zepzelca; Jazz Pharmaceuticals and PharmaMar).

Already approved to treat ovarian cancer, Rubraca (rucaparib) has been granted accelerated approval as the first PARP inhibitor to treat certain patients with prostate cancer, offering a completely new approach for physicians.

Based on the results of an open-label trial, selpercatinib (Retevmo) becomes the first targeted therapy to be granted accelerated approval by the FDA for use in patients with cancer who have certain tumors that have an alteration (mutation or fusion) in the RET gene.