FDA approves Foundation Medicine’s diagnostic for Bayer’s tumor-agnostic med Vitrakvi

FDA approves Foundation Medicine’s diagnostic for Bayer’s tumor-agnostic med Vitrakvi

Foundation Medicine has nabbed a U.S. green light as the only companion diagnostic for Bayer’s Vitrakvi (larotrectinib).

The FoundationOne CDx genomic test is now available to seek out patients who express the NTRK1/2/3 gene fusions, a rare mutation but one that hits across many solid tumors.

This is good for Foundation, now part of Swiss Big Pharma Roche, and builds on a series of similar approvals across other companies and cancer meds—but this OK is probably bigger for Bayer.

In the summer, the German biopharma admitted that it’s been a struggle to find patients for Vitrakvi, both from the viewpoint of COVID-19 but also because of a lack of genomic testing.

Bayer board member Stefan Oelrich told analysts on a call in August that it may be “too sophisticated for physicians to diagnose patients appropriately” but that Bayer was working on the problem.

The new test from Foundation should go some way toward a solution, though issues over patient and doctor awareness on the need for such a test, and the specific gene fusions involved, all alongside a pandemic, will likely remain barriers for Vitrakvi’s marketability.

The test has been given under an accelerated review, but Foundation must prove more deeply its clinical worth if it is to hold on to a full approval.

“Vitrakvi has a demonstrated clinical profile and is the only approved treatment specifically developed for patients with TRK fusion cancer,” said Robert LaCaze, member of the executive committee of the pharmaceuticals division and head of the oncology strategic business unit at Bayer.

“The U.S. FDA approval of FoundationOne CDx for Vitrakvi allows patients who may benefit from this treatment to be identified in a more precise way. We look forward to continuing our global collaboration with Foundation Medicine by expanding access to testing and determining the right treatment options for patients with cancer.”

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