The sBLA was accepted by the US FDA with an assigned PDUFA date of Oct 8, 2024. Earlier in Jan 2024, the EMA validated the type II variation application depicting submission completion & initiation of the review process
Both submissions were based on the P-III (CheckMate-77T) trial evaluating neoadjuvant Opdivo + CT followed by surgery & adjuvant Opdivo vs neoadjuvant CT + PBO followed by surgery & adjuvant PBO in patients (n=452) with resectable stage IIA to IIIB NSCLC. The 1EP was EFS & 2EPs were OS, pCR & MPR
The trial depicted improvements in EFS, benefits in pCR & MPR & safety profiles consistent with previous NSCLC studies & the assessment of OS is ongoing. The results were presented at ESMO 2023
Ref: BMS | Image: BMS
Related News:- BMS Reports 4-Year Follow-Up Data for Opdivo with Cabometyx in P-III Trial to Treat Advanced Renal Cell Carcinoma (RCC)
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