Merck's Keytruda nabs FDA's 'priority' tag in microsatellite instability-high cancer

Merck's Keytruda has grabbed the FDA's priority review distinction as a therapy for previously treated patients with advanced microsatellite instability-high cancer.

Merck’s Keytruda isn’t letting rival Opdivo from Bristol-Myers Squibb soak up all the November regulatory attention. The immuno-oncology med has taken the spotlight back with a priority review tag from the FDA.

The agency doled out the distinction to Keytruda for the treatment of previously treated patients with advanced microsatellite instability-high cancer, the New Jersey pharma giant said on Monday, and it should speed the med’s path down the regulatory pathway.

If Keytruda ultimately snags an approval, Merck will add it to the list of indications its budding star already boasts in melanoma, non-small cell lung cancer and head-and-neck cancer. Microsatellite instability-high cancer is an area where Merck’s competitors haven’t yet hit the market, meaning it’s an opportunity to build a lead.


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Keytruda and Opdivo have been racing to rack up indications since both meds hit the scene as melanoma treatments in late 2014. Opdivo shot out to an early lead last year with an all-important lung cancer nod, but as the drugmakers have scrambled to move their meds into earlier—and more lucrative—lines of therapy, Keytruda has emerged victorious: After Bristol-Myers revealed that Opdivo had flunked a first-line monotherapy trial, Merck followed up last month with an FDA first-line green light.

BMS did, however, nab a European go-ahead last week for Opdivo in classical Hodgkin lymphoma patients whose disease has returned after autologous stem cell transplant and treatment with Seattle Genetics’ Adcetris. And earlier in the month, it became the first med in its class to post positive phase 3 results in a gastric cancer study and evened the score with Keytruda in head-and-neck cancer by grabbing its own FDA approval in the space.

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