Krazati Approved for KRASG12C-Mutated Locally Advanced or Metastatic NSCLC
Krazati is a highly selective and potent oral small molecule inhibitor of KRASG12C.
Krazati is a highly selective and potent oral small molecule inhibitor of KRASG12C.
The approval was based on data from a phase 2 study that included 49 patients with unresectable or metastatic ASPS.
In preclinical studies, WP1122 has shown to increase cellular uptake of 2-DG, increase drug half-life, and increase the ability to cross the blood brain barrier.
The decision to withdraw the indication was made based on findings from the subsequent confirmatory phase 3 IMvigor130 trial.
Olutasidenib is a small-molecule inhibitor of mutated IDH1.
According to the CRL, the application could not be approved in its present form as additional data, including a randomized controlled trial, would be required.
Epcoritamab is designed to bind to CD3 on T cells and CD20 on B cells, inducing T cell mediated killing of CD20+ cells.
The MWF dosing option was approved under the Real-Time Oncology Review program based on data from the intramuscular administration part of a phase 2/3 trial.
The decision to restrict the indication follows an FDA review of the double-blind, placebo-controlled phase 3 ENGOT-OV16/NOVA trial.
The approval was based on data from the SORAYA trial.