Skyrizi Approved for Moderately to Severely Active Crohn Disease
The approval was based on data from two phase 3 induction studies, and one phase 3 maintenance study.
Colorectal And Other GI Cancers
Oral STAT3 Inhibitor Granted Orphan Drug Status for Hepatocellular Carcinoma
Direct inhibition of STAT3 signaling by TTI-101 is expected to lead to reduced tumor growth.
Futibatinib Gets Priority Review for Locally Advanced or Metastatic Cholangiocarcinoma
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.
Maintenance of Clinical Remission Observed With Mirikizumab in UC Trial
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.
FDA Rejects Pedmark NDA Again Citing Manufacturing Deficiencies
The application could not be approved in its present form due to manufacturing deficiencies.
Rivoceranib Designated Orphan Drug for Hepatocellular Carcinoma
Rivoceranib is an orally administered, small molecule inhibitor of vascular endothelial growth factor receptor 2 (VEGFR-2).
Novel Multikinase Inhibitor Gets Fast Track Status for Cholangiocarcinoma
The designation is based on results from a phase 1 study that evaluated TT-00420 at different dose levels in 9 CCA patients.
Erbitux Plus Encorafenib Approved for BRAF V600E Mutation-Positive Metastatic Colorectal Cancer
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.
AbbVie Seeks Approval of Risankizumab for Crohn Disease
The application is supported by data from two phase 3 induction studies (ADVANCE and MOTIVATE) and one phase 3 maintenance study (FORTIFY).
Tislelizumab Under Review for Esophageal Squamous Cell Carcinoma
The application is supported by data from the phase 3 RATIONALE 302 trial.
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