Drugs in the Pipeline
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.
Drugs in the Pipeline
A PDUFA target date of November 24, 2022 has been set for the application.
Drugs in the Pipeline
Nereus Pharmaceuticals announced that it is conducting a randomized Phase 2 clinical trial evaluating the vascular disrupting agent (VDA) NPI-2358.
Drugs in the Pipeline
Synta announced results from its Phase 2 study of ganetespib (STA-9090) for the treatment of NSCLC.
Drugs in the Pipeline
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.
Drugs in the Pipeline
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.
Drugs in the Pipeline
Tragara announced the completion of patient enrollment to its APRiCOT-L study, a Phase 2 trial of its anti-cancer agent, Capoxigem (apricoxib, TG01), in non-small cell lung cancer (NSCLC).
Drugs in the Pipeline
ArQule and Daiichi Sankyo announced the presentation of data from a Phase 2 trial showing encouraging overall survival (OS) results with ARQ 197 in combination with erlotinib among patients with advanced, refractory non-small cell lung cancer (NSCLC).
Drugs in the Pipeline
ADVENTRX Pharmaceuticals announced that the FDA has accepted for filing the New Drug Application (NDA) submitted for Exelbine (vinorelbine injectable emulsion or ANX-530) for the treatment of non-small cell lung cancer (NSCLC).
Drugs in the Pipeline
Bristol-Myers Squibb announced positive results from its Phase 2 study evaluating ipilimumab in combination with standard chemotherapy in previously untreated patients with advanced non-small cell lung cancer (NSCLC).
