Regeneron Receives CHMP's Positive Opinion Recommending the Approval of Libtayo (cemiplimab) for NSCLC and BCC
Shots:
- The CHMP recommended the approval of Libtayo as a 1L treatment for adults with NSCLC expressing PD-L1 in ≥50% of tumor cells with no EGFR- ALK or ROS1 aberrations- based on the P-III EMPOWER-Lung 1 study
- The positive opinion of Libtayo in LA and mBCC is based on P-II EMPOWER-BCC 1 study in patients who either progressed on HHI therapy- had not had an objective response after 9mos. on HHI therapy- or were intolerant of prior HHI therapy
- The EC is expected to decide on both indications in the coming months
Ref: Regeneron | Image: Investros Business Daily
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