Eli Lilly received a significant boost after the U.S. FDA granted Breakthrough Therapy Designation (BTD) to a novel oncology candidate, aiming to fast-track the development of the cancer treatment.
- The designation was based on promising Phase 1 data, which demonstrated an objective response rate between 45% and 50%.
- The move reinforces LLY's strategic ambition to diversify its portfolio beyond key drugs like Mounjaro and Zepbound.
- The company is now initiating the critical Phase 3 study for the candidate.