Zymeworks bags 'Breakthrough' status for zanidatamab in biliary tract cancer

Canadian biotech Zymeworks (TSX: ZYME) today revealed that the US Food and Drug Administration has granted Breakthrough Therapy designation for zanidatamab (formerly known as ZW25) in patients with previously-treated HER2 gene-amplified biliary tract cancer (BTC), with the news pushing the firm’s shares up more than 5% to $52.31 in early trading.

The FDA grants Breakthrough Therapy designation to new medicines that are intended to treat a serious condition and where clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint. Zanidatamab, a novel Azymetric bispecific antibody, will now be eligible for Accelerated Approval, Priority Review and Rolling Review, as well as intensive FDA guidance on an efficient drug development program.

“This Breakthrough Therapy designation from the FDA, based on data generated in BTC patients treated in the initial Phase I trial, is recognition of the potential of zanidatamab to provide a new approach to cancer treatment,” said Dr Diana Hausman, chief medical officer at Zymeworks. “This milestone supports our strategy for accelerated approval and will help make zanidatamab available for patients as quickly as possible,” she noted.