Shots: The approval is based on P-II Brigatinib-2001 (J-ALTA) assessing Alunbrig in 72 Japanese patients with ALK+ NSCLC and P-III AP26113-13-301 (ALTA-1L) study assessing Alunbrig (180mg, qd with seven-day lead-in at 90mg, qd) vs crizotinib (250mg, bid) in 275 patients with ALK+ advanced NSCLC prior not treated with an ALK inhibitor The therapy showed effectiveness […]Read More
Shots: The EC’s approval is based on P-III ALTA-1L study assessing Alunbrig (180mg, qd with seven-day lead-in at 90mg, qd) vs crizotinib (250mg, bid) in 275 patients with ALK+ LA/m-NSCLC prior not treated with an ALK inhibitor The P-III ALTA-1L study results: Alunbrig showed superiority in anti-tumor activity, @2+yrs. follow up, reduction in risk of […]Read More
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
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
Copyright ©2021 PharmaShots | Powered by Octavus Consulting
