December 2023 Brief

The FDA has granted accelerated approval to pirtobrutinib for the treatment of patients with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma.

A phase 1 trial plans to be initiated in 2024 to investigate GTB-3650 for the treatment of patients with CD33-positive leukemia.

CT071, a chimeric antigen receptor T-cell therapy candidate, had an investigational new drug application cleared by the FDA for patients with relapsed/refractory multiple myeloma and primary plasma cell leukemia.

Summary: The FDA has accepted for priority review nivolumab and cisplatin-based chemotherapy as a first line of treatment in patients with inoperable or metastatic urothelial carcinoma.

The FDA has granted priority review to the supplemental biologics application of mirvetuximab soravtansin-gynx for the treatment of patients with platinum-resistant ovarian cancer.

TAR-200, a novel targeted therapy, has been granted breakthrough therapy designation by the FDA in high-risk non-muscle-invasive bladder cancer that is unresponsive to Bacillus Calmette-Guérin.

The FDA has granted 2 designations to cretostimogene grenadenorepvec, an oncolytic immunotherapy, for the treatment of a specific type of high-risk bladder cancer:

An investigational new drug application for VIPER-101, a chimeric antigen receptor T-cell therapy, has been cleared by the FDA in T-cell lymphoma.

The FDA has granted priority review approval to tarlatamab for advanced small cell lung cancer based on encouraging results in a phase 2 clinical trial.

The FDA has approved eflornithine to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma.

Belzutifan is now an FDA-approved treatment for adult patients with advanced renal cell carcinoma.

The FDA has granted approval to the combination of enfortumab vedotin-ejfv and pembrolizumab for the treatment of patients with locally advanced or metastatic urothelial cancer.

The FDA has issued a complete response letter which will delay the potential approval of cosibelimab for patients with cutaneous squamous cell carcinoma.

The FDA has granted clearance to a promising new agent, AVS100, for a phase 1 trial to target solid tumors.

A phase 1 study investigating padeliporfin vascular targeted photodynamic in patients with unresectable pancreatic adenocarcinoma will begin following the FDA clearance of an investigational new drug application.

The FDA is considering 2 applications for amivantamab plus lazertinib as a first-line treatment for EGFR-mutated non–small cell lung cancer, based on the phase 3 MARIPOSA study.