The NDA submission is supported by data from the phase 2b trial evaluating futibatinib in adults with previously treated locally advanced or metastatic cholangiocarcinoma harboring FGFR2 gene rearrangements.
LUCENT-2 is a maintenance study evaluating the efficacy and safety of mirikizumab in patients who achieved clinical response in the 12-week LUCENT-1 induction study.
The application could not be approved in its present form due to manufacturing deficiencies.
Rivoceranib is an orally administered, small molecule inhibitor of vascular endothelial growth factor receptor 2 (VEGFR-2).
The designation is based on results from a phase 1 study that evaluated TT-00420 at different dose levels in 9 CCA patients.
The approval is supported by data from the phase 3 BEACON CRC trial in adults with BRAF V600E mutation-positive metastatic colorectal cancer with disease progression.
The application is supported by data from two phase 3 induction studies (ADVANCE and MOTIVATE) and one phase 3 maintenance study (FORTIFY).
The application is supported by data from the phase 3 RATIONALE 302 trial.
The approval was based on data from the double-blind, placebo-controlled ClarIDHy study.
In September 2017, the FDA granted accelerated approval to Keytruda for recurrent locally advanced or metastatic gastric or GEJ adenocarcinoma.
