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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US FDA approval of Rubraca's all-comers maintenance therapy for platinum-sensitive ovarian cancer continues model that Zejula and Lynparza used for a broad maintenance indication, with data broken out for germline BRCA mutation-positive patients in the clinical trials section of labeling.
Takeda's recent deals include a license in Asian for Tesaro's PARP inhibitor Zejula. Meanwhile, Japanese rival Mitsubishi Tanabe is paying roughly $1bn to acquire Israel's NeuroDerm.
US FDA Continues Shift From Companion To Complementary PD-L1 Diagnostics With AstraZeneca Imfinzi Approval
AstraZeneca's Imfinzi (durvalumab) is the third PD-1/L1 inhibitor approved for second-line bladder cancer with labeling that describes better response rates in patients with higher PD-L1 expression, but without a requirement for diagnostic testing.