Author | Silas Inman


LOXO-292 Granted Breakthrough Therapy Designation for Lung and Thyroid Cancer

September 05, 2018

The FDA has granted LOXO-292 a breakthrough therapy designation for the treatment of patients with RET fusion–positive non–small cell lung cancer (NSCLC) or RET-mutant medullary thyroid cancer (MTC). This designation will expedite the development and review of the drug.

FDA Updates Immunotherapy Labels for Bladder Cancer Treatment

June 21, 2018

The FDA has incorporated PD-L1 status into the labels for Keytruda (pembrolizumab) and Tecentriq (atezolizumab) for existing frontline approvals for platinum-ineligible patients with urothelial carcinoma, based on lower overall survival (OS) rates with the PD-1/PD-L1 inhibitors compared with platinum-based chemotherapy for patients with PD-L1–low expressing platinum-eligible urothelial carcinoma.

x