News Related to Eli Lilly and Company

Related coverage linked through entity extraction aliases.

FDA Accepts Roche's Giredestrant Filing for ESR1-Mutated Breast Cancer

Feb 20, 2026

The FDA has accepted Roche's new drug application for oral SERD giredestrant in ESR1-mutated, ER-positive advanced breast cancer, with a decision expected by December 18, 2026. The filing is restricted to the ESR1-mutant population despite phase 3 trial benefits in broader patients.

FDA Grants Fast Track Designation for Pelareorep in Colorectal Cancer

Feb 17, 2026

Oncolytics Biotech received FDA Fast Track Designation for pelareorep in second-line KRAS-mutant microsatellite-stable metastatic colorectal cancer, based on clinical data showing a 33% response rate and median overall survival of 27 months versus 11.2 months with standard treatment.