FDA OKs Tesaro’s niraparib for ovarian cancer, handing the biotech a big win on the label
The FDA has wasted no time in giving Tesaro $TSRO a broad approval for the use of its PARP drug niraparib, which will now be marketed as Zejula as a maintenance therapy for recurrent ovarian cancer.
The OK and the label that came with it represents a setback for Myriad Genetics $MYGN, which had argued that its companion diagnostic would be needed to identify a specific group of ovarian cancer patients with a biomarker indicating that they would most likely benefit. But regulators blew past any diagnostic qualification in giving Tesaro the label that it was looking for, vindicating CEO Lonnie Moulder’s vow that he could get an OK aimed at a large segment of the market.
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