Tags : atezolizumab

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

Roche Reports Submission of sBLA to the US FDA for

Shots: The sBLA is based on P-III IMbrave150 study involve assessing of Tecentriq (1200mg, IV) + Avastin (IV, 15 mg/kg) vs Sorafenib (PO, 400mg, bid) in 501 patients in a ratio 2:1 with unresectable HCC prior not treated with systemic therapies The P-III IMbrave150 study results: 42% reduction in risk of death; 41% reduction in […]Read More