FDA grants accelerated approval to AstraZeneca’s Calquence for mantle cell lymphoma treatment

AstraZeneca has achieved a significant milestone with the early FDA approval of Calquence (acalabrutinib) for the treatment of adult patients with mantle cell lymphoma who have undergone at least one prior therapy. This announcement, made by the U.S. Food and Drug Administration on Tuesday, marks a crucial development in the treatment of this aggressive form of blood cancer, which accounts for 3-10% of all non-Hodgkin lymphoma cases in the United States according to the National Cancer Institute at the National Institutes of Health.

The Significance of Calquence’s Approval

Calquence has been developed as a selective inhibitor of Bruton tyrosine kinase (BTK), an enzyme that plays a key role in the multiplication and spread of cancer cells. The drug’s accelerated approval was granted under the FDA’s Accelerated Approval pathway, which allows for the early approval of drugs that treat serious conditions and fill an unmet medical need based on a surrogate endpoint.

Clinical Trial Success and Future Prospects

The approval of Calquence was based on its performance in the ACE-LY-004 phase 2 trial, which showed an overall response rate of 80% among 124 patients with mantle cell lymphoma who had previously undergone therapy. Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the FDA Center for Drug Evaluation and Research, noted the drug’s high response rates in initial studies, stating, “For patients who have not responded to treatment or have relapsed, Calquence provides a new treatment option.”

AstraZeneca’s Commitment to Hematology and Oncology

AstraZeneca’s CEO, Pascal Soriot, commented on the approval, highlighting it as a landmark moment for the company: “The accelerated approval of Calquence is a landmark moment for our company. It provides an exciting new treatment option for patients with mantle cell lymphoma and marks the first approval of a medicine that will be the cornerstone of our presence in hematology.”

Ongoing Research and Confirmatory Trials

AstraZeneca has stated that continued approval for Calquence in this indication may be contingent upon verification and description of clinical benefits in confirmatory trials. This underscores the importance of ongoing research to fully establish the drug’s efficacy and safety profile.

This FDA approval not only offers new hope to patients battling mantle cell lymphoma but also demonstrates AstraZeneca’s commitment to advancing scientific leadership in oncology. The development of Calquence as a BTK inhibitor underscores the importance of targeted therapy in the management of complex cancers.