'Breakthrough' status for Calquence for chronic lymphocytic leukemia

The US Food and Drug Administration has granted Breakthrough Therapy designation (BTD) for Calquence (acalabrutinib) as a monotherapy treatment for adult patients with chronic lymphocytic leukemia (CLL), one of the most common types of leukemia in adults. the drug’s developer, AstraZeneca (LSE: AZN), announced this morning.

José Baselga, executive vice president, Oncology R&D, at the Anglo-Swedish pharma major, said: “This is an important regulatory milestone for our work in hematology and for patients living with chronic lymphocytic leukemia, a life-threatening disease. The Breakthrough Therapy Designation acknowledges the growing body of evidence that supports Calquenceas a highly-selective Bruton tyrosine kinase inhibitor with the potential to offer patients a new, differentiated, chemotherapy-free treatment option with a favorable safety profile.”

The designation also paves the way for speedy approval of an important added indication for the drug, which has already been approved by the FDA and other regulatory agencies for the treatment of adults with relapsed or refractory mantle cell lymphoma (MCL).

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