Tafinlar-Mekinist Combo Wins Tumor-Agnostic Indication for BRAF V600E Solid Tumors
The accelerated approval was based on data from two phase 2 trials: the ROAR basket study and the NCI-MATCH Subprotocol H study.
The accelerated approval was based on data from two phase 2 trials: the ROAR basket study and the NCI-MATCH Subprotocol H study.
The addition of nivolumab to chemotherapy demonstrated continuing improved survival compared with chemotherapy alone after 24 months of follow-up.
The median PFS was 8.0 months with TARE and 7.2 months with chemotherapy alone.
Adding toripalimab to standard first-line chemotherapy significantly prolonged survival in patients with advanced esophageal squamous cell carcinoma.
The association was observed with colon cancer but not rectal cancer.
In September 2017, the FDA granted accelerated approval to Keytruda for recurrent locally advanced or metastatic gastric or GEJ adenocarcinoma.
The accelerated approval was based on data from the KEYNOTE-811 study.
Results presented at the European Society for Medical Oncology Virtual Congress 2020showed significant improvements in the primary endpoints for the pembrolizumab group.
The supplemental Biologics License Application includes data from the open-label, randomized phase 2 DESTINY-Gatric01 trial.
This slideshow shows drug information for Qinlock. Click here for the complete Qinlock monograph.