FDA Approves First All-Oral, Fixed-Duration First-Line CLL/SLL Regimen: Calquence Plus Venetoclax

Overview

• The authorization covers previously untreated adults with chronic lymphocytic leukaemia or small lymphocytic lymphoma, marking the first BTK inhibitor–based finite course in the U.S.
• AMPLIFY showed 77% of patients on the combination were progression-free at three years versus 67% with chemoimmunotherapy, with median PFS not reached versus 47.6 months and a 35% lower risk of progression or death (HR 0.65; p=0.0038).
• The regimen is a 14-cycle, approximately 14-month, all-oral course, with venetoclax beginning in cycle three after a five-week ramp-up.
• Investigators reported safety consistent with known profiles with no new signals, and common adverse events included neutropenia, headache and diarrhea.
• The trial excluded patients with del(17p) or TP53 mutation, and the combination already holds approvals in the EU, UK and Canada with additional reviews under way in other countries.