EMA
EMA's CHMP Recommends Approval for BMS' Opdivo Plus Yervoy for Certain Colorectal Cancer Patients
The committee recommended the combination for patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer.
CHMP Recommends Merck's Keytruda Plus Chemo for Certain Esophageal, Gastroesophageal Cancers
The EMA committee recommended approval for pembrolizumab plus chemo as first-line treatment for patients whose tumors express a PD-L1 CPS of 10 or more.
EMA's CHMP Issues Positive Opinion on Regeneron, Sanofi's Libtayo in NSCLC
The committee recommended approval for the anti-PD-1 drug in first-line NSCLC patients who have PD-L1 expression in at least 50 percent of tumor cells.
AstraZeneca's Tagrisso Recommended by EMA Committee in Adjuvant NSCLC
The CHMP evaluated data showing the drug reduced the risk of disease recurrence or death by 80 percent in EGFR-mutated, stage Ib to IIIa NSCLC patients.
CHMP Recommends Approval of GSK's Dostarlimab in Endometrial Cancer
The CHMP opinion is based on data from a Phase I/II study of dostarlimab in mismatch repair-deficient or microsatellite instability-high endometrial cancer.