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.
Findings showed that treatment with cemiplimab-rwlc plus platinum-based chemotherapy demonstrated a statistically significant improvement in overall survival.
First-line cemiplimab can improve long-term survival outcomes, compared with chemotherapy, in advanced non-small cell lung cancer.
Many patients with advanced non-small cell lung cancer do not survive long enough to receive second-line therapy, a real-world study suggests.
Advanced disease at diagnosis is more likely among younger patients with non-small cell lung cancer, according to a new study.
Combining either oleclumab or monalizumab with durvalumab provided a progression-free survival benefit over durvalumab alone.
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.