AstraZeneca gets FDA nod for Calquence

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AstraZeneca gets FDA nod for Calquence

By David Salazar - 11/02/2017

SILVER SPRING, Md. — The Food and Drug Administration has approved a new lymphoma treatment from AstraZeneca. The company announced this week that its Calquence (acalabrutinib) had been approved to treat patients with mantle cell lymphoma in patients who have received at least one prior therapy.

Mantle cell lymphoma makes up 3-in-10 new non-Hodgkin lymphoma diagnoses in the United States, according to the National Cancer Institute. The drug works by blocking an enzyme that cancer needs to multiply and spread, the FDA said. The regulatory agency approved the drug under its accelerated approval pathway based on its overall response rate, AstraZeneca said.

“The accelerated approval of Calquence is a landmark moment for our company,” AstraZeneca CEO Pascal Soriot said. “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. Furthermore, today's approval demonstrates our commitment to scientific leadership in Oncology and reinforces our progress towards returning to growth.”

Calquence is set to be dispensed by a limited group of specialty pharmacies, which include Diplomat Pharmacy and Avella Specialty Pharmacy

“Calquence is a needed alternative to treat a life-threatening blood cancer for patients who might not be responding to therapy or whose cancer has relapsed,” Diplomat president Joel Saban said.