Topic: mantle cell lymphoma
Brukinsa marked the first cancer drug discovered in China to get an FDA green light. The approval, largely based on tumor shrinkage results from a phase 2 trial in 86 Chinese patients, “provides validation” for using primarily China data to support U.S. drug approvals, SVB Leerink analyst Andrew Berens said.
Kite hopes to win approval for KTE-X19 in mantle cell lymphoma on the strength of midphase results linking it to a 67% complete response rate.
Lilly unveiled early clinical data on the BTK inhibitor it acquired with Loxo Oncology—and the numbers are strong enough to prompt some action.