Kristi Rosa

Mirvetuximab soravtansine-gynx (Elahere) was first granted FDA accelerated approval in November 2022.

The drug, called Lumisight, is an optical imaging agent that detects cancerous tissue during initial lumpectomy to allow for a more complete resection. An NDA has been submitted to the FDA.

The FDA has accepted for review a biologics license application for the use of toripalimab in combination with gemcitabine and cisplatin in the frontline treatment of patients with advanced recurrent or metastatic nasopharyngeal carcinoma.

The FDA has approved the VENTANA PD-L1 assay to assist in identifying which adult patients with stage II to IIIA non–small cell lung cancer whose tumors have PD-L1 expression on 1% or more of tumor cells are eligible to receive adjuvant atezolizumab following surgery and platinum-based chemotherapy.

Updated outcomes from the ongoing phase 1/2 GO40554 trial show that mosunetuzumab monotherapy demonstrated promising efficacy and a tolerable safety for elderly/unfit patients with previously untreated first-line diffuse large B-cell lymphoma.