Latecomer Libtayo Wins Coveted First-Line NSCLC Monotherapy Indication
Sanofi/Regeneron's PD-1 inhibitor Libtayo joins Keytruda and Tecentriq as the only PD-1/L1s approved by the US FDA as monotherapy for first-line non-small cell lung cancer.
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The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Data from CheckMate-9LA and -227 that will be presented at the ASCO virtual meeting support a low-dose chemo combo with the two drugs and the newly US FDA-approved chemo-free indication.
The Phase III NEPTUNE lung cancer trial found the combination of Imfinzi and tremelimumab was no better than chemotherapy at extending overall survival. After repeat setbacks, AstraZeneca is now running out of opportunities to show its dual checkpoint blockade is effective in NSCLC.