FDA Approves AstraZeneca's Calquence for Previously Treated Mantle Cell Lymphoma

The US Food and Drug Administration (FDA) has granted accelerated approval for AstraZeneca's Calquence (acalabrutinib). The drug is indicated for adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. MCL is an aggressive blood cancer with a high relapse rate.

The accelerated approval was based on the drug's overall response rate, a pathway designed for earlier access to treatments for serious conditions that address unmet medical needs. Continued approval for this indication is contingent upon verification of clinical benefit in confirmatory trials.

Calquence is a selective Bruton tyrosine kinase (BTK) inhibitor. Preclinical studies indicated that acalabrutinib covalently binds to BTK, inhibiting its activity with minimal interactions with other immune cells. In B cells, BTK signaling is critical for proliferation, trafficking, and adhesion.

Data from the ACE-LY-004 trial, involving 124 patients with relapsed or refractory MCL, showed an 80% overall response rate, with 40% achieving a complete response. The most common adverse reactions included anemia, thrombocytopenia, headache, neutropenia, diarrhea, fatigue, and pain.

This approval signifies AstraZeneca's entry into the field of blood cancer treatment and provides a new therapeutic option for MCL patients. The company is further investigating acalabrutinib for other blood cancers and solid tumors, as well as in combination therapies.