Shots: The approval is based on P-III JAVELIN Bladder 100 study assessing Bavencio (10 mg/kg, IV infusion, q2w) + BSC vs BSC as monothx. in 700 patients with LA/ m-UC whose disease had not progressed after 1L platinum-based induction CT as per RECIST v1.1 Results: median OS (7.1 vs 21.4mos.); improvement in OS represents a […]Read More
Shots: The EMA has validated the type II variation application for Bavencio which is based on P-III JAVELIN Bladder 100 study assessing Bavencio +BSC vs BSC as monothx. in 700 patients whose disease had not progressed after platinum-based induction CT as per RECIST v1.1 Following the completion of the application, the EMA will now initiate […]Read More
Shots: The companies have completed the submission of sBLA to the US FDA as 1L maintenance therapy for patients with LA/m-UC and have received FDA’s BT designation for the same indication. The sBLA is being reviewed under the FDA’s RTOR pilot program The sBLA is based on P-III JAVELIN Bladder 100 study assessing Bavencio + […]Read More
Shots: The P-III JAVELIN Bladder 100 study involves assessing of Bavencio + best supportive care (BSC) vs BSC monothx in 700 patients with LA or mUC whose disease did not progress after completion of 1L Pt-chemotherapy The study resulted in improvement in OS with consistent safety results and will be shared with the US FDA […]Read More
Shots: The P-1b/2 KEYNOTE-146/Study 111 trial involves assessing of Lenvima (20 mg/day) + Keytruda (200 mg IV q3w) in patients with NSCLC, Advanced melanoma & urothelial cancer P1b/2 KEYNOTE-146/Study 111 results: NSCLC: ORR 33.3%, mPFS 5.9 mos., mDOR 10.9 mos.; Advanced melanoma: ORR 47.6%, mPFS 5.5 mos., mDOR (12.5 mos.); Metastatic Urothelial Carcinoma: ORR 25%, […]Read More
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