The accelerated approval was based on data from from the single-arm trial LY-004 (n=124) that evaluated the overall response rate (ORR) among adults with mantle cell lymphoma who received ≥1 prior therapy; median follow-up was 15.2 months. The data showed an ORR of 81% (95% CI: 73, 87) with 40% of patients having complete response and 41% having partial response. The median time to best response was 1.9 months.
Calquence, a small-molecule inhibitor of BTK, works by forming a covalent bond with the cysteine residue in the BTK active site, leading to BTK enzymatic activity inhibition. In non-clinical studies, Calquence inhibited BTK-mediated activation of downstream signaling proteins CD86 and CD69 and inhibited malignant B-cell proliferation and survival.
Headache, diarrhea, bruising, fatigue, myalgia, anemia, thrombocytopenia, and neutropenia were reported as common adverse effects of Calquence. Serious adverse effects included hemorrhage, infections, and atrial fibrillation; second primary malignancies have also occurred in some patients.
Calquence was previously granted Priority Review, Breakthrough Therapy, and Orphan Drug designation by the FDA. It will be available as 100mg strength capsules in 60-count bottles.
For more information call (800) 236-9933 or visit AstraZeneca.com.