FDA

ASCO looming, Loxo, Bayer line up a quick shot at FDA OK for their groundbreaking approach to cancer therapy

Just days away from learning more about Loxo Oncology’s $LOXO closely-watched cancer drug larotrectinib at ASCO, the company is setting the stage with the news that the FDA has come through with a fast-paced priority review plan to whisk the drug through an agency inspection process.

The shortened priority game plan gives Loxo and its partners at Bayer a marketing decision date of November 26 with analysts giving this one good odds of success based on the data we’ve seen.

CEO Josh Bilenker’s statement today highlighted the drug’s focus on tumor genetics rather than site of development, a twist that highlights a new sector in the field of cancer drug development.

Last year at ASCO Loxo cobbled together response data from three early-stage trials, and scored big.

Specifically there were 50 patients — 43 adults and 12 children children and adults with TRK fusion cancer — with 12% complete and 64% partial responders. That’s a high rate of success and it fits with their earlier statements on progress in the clinic. Small groups of patients like this are also not unusual for a cancer type shared by only a few thousand US patients.

A few months later Bayer bought in, handing over a $400 million upfront, $450 million in milestones for the development and first sale of larotrectinib, with another $200 million on the table for LOXO-195. There’s also $500 million on the books for commercial goals.


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Molecular Templates Austin, TX
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Molecular Templates Austin, TX
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Koneksa Health New York, NY

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