Tags : Advanced Non-Small Cell Lung Cancer

Biotech

Roche Reports the US FDA Acceptance of sBLA and Granted

Shots: The sBLA submission is based on P-III IMpower110 study assessing Tecentriq as monothx. vs CT in 572 PD-L1-selected (TC3/IC3-WT), CT-naïve patients with advanced sq. or non-sq. NSCLC without ALK or EGFR mutations The P-III Impower110 study results: improvement in OS by 7.1mos. (20.2 vs 13.1mos.), the safety profile is consistent with its known safety […]Read More

Regulatory

Merck’s Keytruda Receives NMPA’s Approval as Monotherapy for 1L Treatment

Shots: The NMPA approval is based on the P-III KEYNOTE-042 study assessing Keytruda as monothx. vs CT in patients with stage III NSCLC who were not candidates for surgical resection/definitive chemoradiation/mNSCLC with PD-L1 expression & no prior systemic treatment for mNSCLC including data from the extension of KEYNOTE-042 in Chinese patients The extension study results […]Read More