Acalabrutinib FDA approval : AstraZeneca has secured an early approval for its blood cancer drug Calquence (acalabrutinib) for the treatment of mantle cell lymphoma in adult patients who were subjected to a minimum of one prior therapy for the rare type of blood cancer.
According to the National Cancer Institute at the National Institutes of Health, mantle cell lymphoma accounts for 3-10% of all non-Hodgkin lymphoma cases in the United States.
On Tuesday, the US Food and Drug Administration announced the accelerated approval for the AstraZeneca blood cancer drug for mantle cell lymphoma treatment.
Commenting on acalabrutinib FDA approval for mantle cell lymphoma treatment, Richard Pazdur, who is the FDA Oncology Center of Excellence director and FDA Center for Drug Evaluation and Research acting director, said: “Mantle cell lymphoma is a particularly aggressive cancer.
“For patients who have not responded to treatment or have relapsed, Calquence provides a new treatment option that has shown high rates of response for some patients in initial studies.”
Calquence has been developed to be a selective Bruton tyrosine kinase (BTK) inhibitor. The BTK enzyme has been known for aiding the multiplication and spreading of cancer.
The AstraZeneca blood cancer drug Calquence was approved by the FDA under the drug regulator’s Accelerated Approval pathway. Under this, FDA can grant earlier approval for drugs that treat serious conditions, and that fill an unmet medical need based on a surrogate endpoint.
In Calquence’s case, the surrogate endpoint is the overall response which was registered as 80% in its ACE-LY-004 phase 2 trial carried out in 124 mantle cell lymphoma patients who previously had at least one therapy.
Continued approval for Calquence for mantle cell lymphoma in such patients may be subject to verification and description of clinical benefit in confirmatory trials, stated AstraZeneca.
AstraZeneca CEO Pascal Soriot on acalabrutinib FDA approval for mantle cell lymphoma treatment commented: “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 haematology.
“Furthermore, today’s approval demonstrates our commitment to scientific leadership in Oncology and reinforces our progress towards returning to growth.”