FDA grants Breakthrough Therapy Designation to lymphoma drug

The designation will help expedite the development and regulatory review.
The designation will help expedite the development and regulatory review. | File photo

AstraZeneca and Acerta Pharma's treatment for patients with mantle cell lymphoma (MCL) who have received at least one prior therapy was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration.

“New treatments are urgently needed for people with mantle cell lymphoma who relapse or do not respond to therapy,” Sean Bohen, executive vice president of Global Medicines Development and chief medical officer at AstraZeneca, said in a statement. “Breakthrough Therapy Designation for acalabrutinib will help us bring this potential medicine to appropriate patients as quickly as possible.”

The designation will help expedite the development and regulatory review; it’s given by the FDA to new medicines designed to treat serious conditions and that have shown positive early results.

“This is an exciting regulatory milestone for our work in hematology,” Acerta Pharma CEO Dr. Flavia Borellini said. “Acalabrutinib is a potent, irreversible BTK inhibitor with a high degree of specificity for its target. If approved, it could be a clinically meaningful treatment option for patients with this devastating disease.”

This if the fifth Breakthrough Therapy Designation the FDA has given for oncology medicines to AstraZenaca since 2014.

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AstraZeneca Pharmaceuticals LP 1800 Concord Pike Wilmington, DE - 19803