Zydus Taps Into Blockbuster Cancer Drug Market with Tentative USFDA Green Light

Zydus Lifesciences Ltd has received tentative approval from the U.S. Food and Drug Administration (USFDA) to market Ibrutinib Tablets in strengths of 140 mg, 280 mg, and 420 mg. The drug is a kinase inhibitor used in the treatment of several types of blood cancers, including chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), mantle cell lymphoma, and Waldenström’s macroglobulinemia.

 

The approval allows Zydus to enter the U.S. market with a generic version of Imbruvica, a blockbuster cancer therapy originally developed by Pharmacyclics and Janssen. The tablets will be manufactured at Zydus’ formulation facility in SEZ, Ahmedabad.

 

Market Impact

Zydus now boasts over 428 USFDA approvals, having filed 492 Abbreviated New Drug Applications (ANDAs) since FY 2003–04.

 

About Ibrutinib

Ibrutinib works by blocking Bruton’s tyrosine kinase (BTK), a protein that helps cancer cells survive and multiply. It’s a first-in-class therapy that revolutionized treatment for certain B-cell malignancies and is often prescribed as a long-term oral regimen.

 

Sources: MarketScreener, Rediff Money, National Cancer Institute: Ibrutinib Drug Profile