US FDA Shows Relaxed Approach On Personalized Medicine In Zejula Approval

Tesaro's ovarian cancer treatment performed better in patients with BRCA mutation, but FDA did not restrict indication, leaving decision to providers.

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The US FDA took another less prescriptive and more descriptive approach when writing the label for Tesaro Inc.'s ovarian cancer treatment Zejula (niraparib).

Even though patients with BRCA mutations performed better on the treatment – which is indicated as maintenance therapy in patients...

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