Keytruda Approved as Adjuvant Treatment for Stage IB, II, or IIIA NSCLC
The approval was based on data from the KEYNOTE-091 trial.
The approval was based on data from the KEYNOTE-091 trial.
Krazati is a highly selective and potent oral small molecule inhibitor of KRASG12C.
According to the CRL, the application could not be approved in its present form as additional data, including a randomized controlled trial, would be required.
The approval was based on data from a phase 3 POSEIDON study.
Findings showed that treatment with cemiplimab-rwlc plus platinum-based chemotherapy demonstrated a statistically significant improvement in overall survival.
The application is supported by data from the registration-enabling cohort of the phase 2 KRYSTAL-1 study evaluating adagrasib in adults with NSCLC harboring the KRASG12C mutation following prior systemic therapy.
A PDUFA target date of November 24, 2022 has been set for the application.
Sugemalimab improved progression-free survival whether patients received sequential or concurrent chemoradiotherapy.
There was no improvement in overall survival with bevacizumab.
There was an improvement in progression-free survival despite crossover.