Regulatory, Setbacks

That’s gotta hurt. FDA turns thumbs down on Spectrum’s ‘breakthrough’ pitch for cancer drug poziotinib and shares tumble

Everybody loves a breakthrough therapy drug designation from the FDA. But woe betide the public biotech company that comes away from the BTD quest empty-handed in this fractious market.

Take Spectrum Pharmaceuticals as an example.

Joe Turgeon

The biotech $SPPI submitted their BTD pitch for poziotinib as a new therapy for metastatic non-small cell lung cancer using mid-stage data, but the agency said nyett, driving their stock down a painful 35% — wiping out hundreds of millions of dollars in market cap.

“Our enthusiasm for poziotinib, our commitment to the program, and our overall development plan remain unchanged,” said Joe Turgeon, the CEO of Spectrum Pharmaceuticals. “We will continue to work with the FDA to achieve the fastest route to approval of poziotinib based on our ZENITH20 study.”

That and $2.70 will get you a cup of coffee.

Planning a BTD, searching for the fast lane to an approval? It’s not all about the upside.


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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
Marketing Associate - Demand Generation
Catalytic Data Science Charleston, SC
Associate Principal, Life Sciences Partnerships
Flatiron Health New York City or San Francisco

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