Tags : 1L

GSK Reports the Acceptance of EMA’s MAA for Zejula (niraparib)

Shots: The EMA has accepted Type II Variation (T2V) for Zejula as maintenance therapy in a 1L setting for women with advanced platinum-responsive advanced OC, regardless of biomarker status. The validation indicates the acceptance of MAA and the initiation of CHMP’s formal review process The submission is based on P-III PRIMA study assessing Zejula vs […]Read More

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