The U.S. Food and Drug Administration (FDA) has granted priority review to an application seeking the approval of Libtayo (cemiplimab) as a first-line therapy for advanced non-small cell lung cancer (NSCLC) and high PD-L1 levels, according to a press release. This priority status is expected to shorten Libtayo’s regulatory review to six months from the standard 10 months, and a decision is expected by Feb. 28, 2021. A similar application is also being reviewed by the European Medicines Agency, with a…
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