Tags : Monotherapy

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

Astellas’ Xospata (gilteritinib) Receives EC’s Approval as Monotherapy for Relapsed

Shots: The approval is based on P-III ADMIRAL study assessing Gilteritinib as monothx. vs salvage CT In patients with relapsed or refractory FLT3mut+ AML. The approval follows EMA’s accelerated assessment and ODD which reduced the timeframe for approval The P-III ADMIRAL study resulted in longer OS i.e, mOS (9.3 vs 5.6mos.); rates of one-year survival […]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

Regulatory

Merck’s Keytruda (pembrolizumab) Receives FDA’s Accelerated Approval as a Monotherapy

Shots: The approval is based on KEYNOTE-158 & KEYNOTE-028 studies result assessing Keytruda (200mg, IV) in patients with SCLC with disease progression on/after platinum-based CT, prior treated with 1L+ therapy Collective results: ORR (19%); CRR (2%); PRR (17%); DOR @6mos. (94%); DOR @12mos. (63%); DOR @18mos. (56%) Keytruda is an anti-PD-1 therapy, blocking the interaction […]Read More