AstraZeneca’s Calquence Gains FDA Approval as First-Line Treatment for Mantle Cell Lymphoma

FDA Approval:
AstraZeneca's Calquence (acalabrutinib) has been approved by the FDA as the first BTK inhibitor for first-line treatment of mantle cell lymphoma (MCL) in adult patients25.

Efficacy:
The approval is based on the ECHO Phase III trial, which demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to standard-of-care chemoimmunotherapy3.

Combination Therapy:
Calquence is used in combination with bendamustine and rituximab, showing a favorable trend in overall survival (OS) in previously untreated adult patients with MCL3.

Safety Profile:
The safety and tolerability of Calquence were consistent with its known safety profile, with no new safety signals identified3.

Market Impact:
This approval positions Calquence as a new standard of care for first-line MCL treatment, offering a robust efficacy and strong safety profile35.

Clinical Development:
AstraZeneca is evaluating Calquence alone and in combination for the treatment of multiple B-cell blood cancers, including chronic lymphocytic leukemia (CLL) and diffuse large B-cell lymphoma3.

Sources:

2. https://www.stocktitan.net/news/AZN/calquence-acalabrutinib-plus-chemoimmunotherapy-approved-in-the-us-7ju5dl48kyy3.html

3. https://www.astrazeneca.com/media-centre/press-releases/2024/calquence-combination-improved-pfs-in-1l-mcl.html

5. https://pharmaphorum.com/news/azs-calquence-gets-first-line-ok-mantle-cell-lymphoma