Zydus Lifesciences Secures Tentative FDA Nod for Generic Cancer Drug

Zydus Lifesciences Ltd announced a significant milestone on Thursday as it received tentative approval from the US Food and Drug Administration (USFDA) for the generic version of the cancer medication Ibrutinib tablets.

This approval covers Ibrutinib tablet strengths of 140 mg, 280 mg, and 420 mg, with production set to take place at the company's Special Economic Zone in Ahmedabad.

Intended to treat a variety of blood cancers, including chronic lymphocytic leukemia, small lymphocytic lymphoma, and Waldenstrom's macroglobulinemia, Ibrutinib tablets represent a lucrative market, with US sales reaching approximately USD 2.15 billion annually, as per IQVIA MAT data for May 2025.

(With inputs from agencies.)