Genentech's Alecensa granted Breakthrough Therapy Designation

Genentech's anaplastic lymphoma kinase (ALK) inhibitor Alecensa has been granted Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration.

Alecensa was granted BTD to treat advanced ALK-positive non-small cell lung cancer in adult patients who have previously received treatment involving an ALK inhibitor.

“The J-ALEX study that supports the second Breakthrough Designation for Alecensa showed superior efficacy versus the standard of care, crizotinib, in Japanese people with advanced ALK-positive disease,” Genentech Chief Medical Officer and Head of Global Product Development Dr. Sandra Horning said. “The decision by the FDA to grant a second Breakthrough Therapy Designation is recognition of the clinically meaningful improvement in efficacy and safety that Alecensa brings to the care of people with advanced ALK-positive lung cancer who have not received prior treatment with an ALK inhibitor.”

When a company receives BTD from the FDA, it allows it to expedite the specified medicine's development and review so a drug can be used to treat patients with serious and life-threatening illnesses and ensure they have access to the medications intended to help treat them as quickly as possible.