Articles related to DEVICE/DRUG APPROVALS

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.

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.