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Sintilimab is an investigational programmed death receptor-1 (PD-1) inhibitor.

The approval was based on data from the CHECKMATE-816 trial.

The application is supported by data from the registration-enabling cohort of the phase 2 KRYSTAL-1 study evaluating adagrasib in adults with NSCLC harboring the KRASG12C mutation following prior systemic therapy.

A PDUFA target date of November 24, 2022 has been set for the application.

The decision was made to withdraw the application after the Companies and the FDA were not able to align on certain postmarketing studies.

Patritumab deruxtecan consists of a fully human anti-HER3 IgG1 monoclonal antibody attached to a topoisomerase I inhibitor payload (an exatecan derivative, DXd) via a stable tetrapeptide-based cleavable linker.

Approval was based on data from the phase 3 KEYNOTE-716 trial, which enrolled 976 participants.

The approval was based on data from the phase 3 IMpower010 study.

Exkivity (mobocertinib) is approved to treat adults with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.

The sBLA is supported by data from the IMpower010 study that compared atezolizumab with best supportive care in 1005 adults with Stage IB-IIIA NSCLC after resection and adjuvant chemotherapy.