Shattering an old record, FDA quickly OKs pioneering, site-agnostic cancer drug larotrectinib from Loxo and Bayer
The FDA has hustled up a quick OK for larotrectinib, offering their stamp of approval for a site-agnostic cancer drug from Loxo Oncology and their partners at Bayer, a prime example of a new wave of oncology drugs hitting the field.
The label for their drug, now called Vitrakvi, was the first thing to hit Twitter after the market closed, which you can see here.
Stamford, CT-based Loxo $LOXO — run by CEO Josh Bilenker — is one of the trailblazers in personalized cancer therapies where patients are grouped not by the site of tumor development but by genetics — an approach that calls for broader sequencing to ID the genetic mutations underpinning each patients’ cancer. That requires lots of work to identify patients. But they have data from a small pivotal study to back up their breakthrough.
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