Novel Factor XI Inhibitor Fast Tracked for Thrombosis Associated With Cancer
Abelacimab is a highly selective, fully human monoclonal antibody designed to inhibit both factor XI and its activated form, factor XIa.
Gastrointestinal Cancer
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.
Long-Term Follow-up Confirms Efficacy, Safety of Nivolumab Plus Chemotherapy in Gastrointestinal Cancers
The addition of nivolumab to chemotherapy demonstrated continuing improved survival compared with chemotherapy alone after 24 months of follow-up.
TARE Prolongs PFS, Not OS, in Colorectal Cancer With Liver Metastases
The median PFS was 8.0 months with TARE and 7.2 months with chemotherapy alone.
Toripalimab Plus Chemotherapy as First-Line Treatment For Metastatic Esophageal Squamous Cell Carcinoma
Adding toripalimab to standard first-line chemotherapy significantly prolonged survival in patients with advanced esophageal squamous cell carcinoma.
Antibiotic Use May Increase the Risk of Early-Onset Colon Cancer
The association was observed with colon cancer but not rectal cancer.
Keytruda Indication for Advanced Gastric Cancer Withdrawn
In September 2017, the FDA granted accelerated approval to Keytruda for recurrent locally advanced or metastatic gastric or GEJ adenocarcinoma.
Keytruda Combo Approved for First-Line Treatment of HER2-Positive Gastric Cancer
The accelerated approval was based on data from the KEYNOTE-811 study.
FDA Accepts and Grants Priority Review to New sBLA for Keytruda
Results presented at the European Society for Medical Oncology Virtual Congress 2020showed significant improvements in the primary endpoints for the pembrolizumab group.
HER2-Directed Treatment Gets Priority Review for Gastric Cancer
The supplemental Biologics License Application includes data from the open-label, randomized phase 2 DESTINY-Gatric01 trial.
