AstraZeneca's PARP inhibitor Lynparza becomes first US FDA-approved drug for pancreatic cancer based on progression-free survival endpoint, providing regulatory precedent for other sponsors to use that development approach; all other pancreatic cancer drugs had been approved based on an overall survival benefit.
The US Food and Drug Administration has opened the door for sponsors to use a progression-free survival (PFS) endpoint in developing pancreatic cancer drugs with the agency's 27 December 2019 supplemental approval of AstraZeneca PLC's Lynparza (olaparib) for the disease.
Lynparza, a PARP inhibitor, is now specifically labeled for the maintenance treatment of adult patients with deleterious or suspected deleterious...
<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>
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<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>
