Articles related to DEVICE/DRUG APPROVALS

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.

The US Food and Drug Administration (FDA) approval – the first for mesothelioma in 16 years and the second FDA-approved systemic therapy for mesothelioma – was based on a randomized, open-label trial, of 605 patients. The endpoint was to determine if the nivolumab-ipilimumab combo improved overall survival compared to chemotherapy.

According to the FDA, Phesgo — the combination of pertuzumab, trastuzumab and hyaluronidase-zzxf – is initially used in combination with chemotherapy and then can be administered subcutaneously at home by a health care professional after completion of chemotherapy.

The FDA granted selinexor (Xpovio, Karyopharm Therapeutics), a nuclear transport inhibitor, accelerated approval for this indication based on the response rate seen in the SADAL trial, a phase 2, single-arm, open-label study of patients with DLBCL who had previously received two to five systemic regimens.

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 the data from the ATTRACTION-3 clinical trial, the FDA approved nivolumab (Opdivo; BMS) for the treatment of patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) who previously received fluoropyrimidine- and platinum-based chemotherapy.