The date for the FDA decision is on 19 September 2022.
The sBLA is backed by results from a randomized, multicenter Phase 3 study.
The study investigated Libtayo along with a physician’s choice of platinum-doublet chemotherapy (Libtayo combination), as against platinum-doublet chemotherapy only.
Patients, who were enrolled for the trial, had locally advanced or metastatic NSCLC, irrespective of PD-L1 expression level or tumor histology, and with no ALK, EGFR or ROS1 aberrations.
The European Medicines Agency was also submitted with a regulatory filing recently.
The Phase 3 trial backing the sBLA was stopped early following demonstration by the Libtayo combination of a significant overall survival improvement as against chemotherapy only.
Among patients figuring in the Libtayo combination and chemotherapy alone groups, treatment discontinuations because of adverse events (AEs) occurred in 5% and 3% of patients, respectively.
In the Libtayo combination group, immune-mediated AEs occurred in 19% of patients.
Last year, Libtayo secured approval in the US and European Union as first-line monotherapy treatment for adult patients suffering with advanced NSCLC whose tumors have high PD-L1 expression, as determined by an FDA-approved test. Such patients must either have metastatic or locally advanced tumors that are otherwise not candidates for surgical resection or definitive chemoradiation, and their tumors must not have EGFR, ALK or ROS1 aberrations.
Invented using Regeneron’s proprietary VelocImmune technology, Libtayo is being jointly developed by Regeneron and Sanofi under a global collaboration agreement.
Regeneron stated that the use of Libtayo along with chemotherapy for advanced NSCLC is investigational, and its “safety and efficacy have not been fully evaluated by any regulatory authority”.