FDA to Review AstraZeneca NDA Seeking Approval for Acalabrutinib to Treat Mantle Cell Lymphoma

FDA to Review AstraZeneca NDA Seeking Approval for Acalabrutinib to Treat Mantle Cell Lymphoma

The U.S. Food and Drug Administration has accepted for review AstraZeneca‘s request to use acalabrutinib — a highly selective BTK inhibitor — to treat relapsed or refractory mantle cell lymphoma (MCL) patients.

The new drug application received priority review, a designation meant to expedite the approval and marketing of potential therapies. It reduces the FDA’s review time from ten to six months. A decision is likely by March 2018.

This follows acalabrutinib’s recent Breakthrough Therapy Designation, given earlier this month by the FDA, for mantle cell lymphoma patients who received at least one prior therapy.

“FDA’s acceptance of the acalabrutinib application and priority review illustrates the impact it could have on patients with relapsed or refractory MCL as we work to bring this potential medicine to those in need as quickly as possible,” Dr. Sean Bohen, executive vice- president of AstraZeneca’s global medicines development unit, said in a press release.

The new drug application relies on data from the Phase 2 ACE-LY-004 trial (NCT02213926), which assessed the safety and efficacy of acalabrutinib in patients with relapsed/refractory MCL who had received at least one prior therapy. The trial is expected to enroll 120 patients, and researchers plan to present results from this trial at an upcoming medical meeting.

Currently, acalabrutinib is being tested as both a stand-alone therapy and in combination with standard-of-care treatments for multiple B-cell cancers. The development plan also includes the Phase 3 ACE-LY-308 clinical study (NCT02972840) testing acalabrutinib as a first-line therapy for patients with MCL. 

Acalabrutinib, also known as ACP-196 ,has been developed as an oral monotherapy or combination therapy for diverse cancers, including chronic lymphocytic leukemia, Waldenström macroglobulinemia, follicular lymphoma, diffuse large B-cell lymphoma and multiple myeloma. The drug is a highly selective and potent inhibitor of Bruton tyrosine kinase, a B-cell protein whose activity is aberrantly increased in certain types of non-Hodgkin’s lymphoma.

In September 2015, the FDA granted Orphan Drug status to acalabrutinib for the treatment of MCL. The European Commission gave the drug that same designation in March 2016 to treat  was given by the European Commission in March 2016 to treat MCL as well as chronic lymphocytic leukemia and Waldenström macroglobulinemia.

“We believe acalabrutinib has the potential to be a very important treatment option for patients with this life-threatening blood cancer,” said Flavia Borellini, CEO of Acerta Pharma, AstraZeneca’s hematology research and development unit. “The FDA’s NDA acceptance exemplifies our progress in the acalabrutinib development program and continues our momentum as we seek to transform care for people with hematologic malignancies.”

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