The U.S. Food and Drug Administration (FDA) will review Ariad‘s new drug application (NDA) for brigatinib, an investigational therapy for patients with non-small cell lung cancer (NSCLC) who have progressed following treatment with Xalkori (crizotinib).
The FDA granted Priority Review status to brigatinib, which accelerates the review time from 10 months to six months from the time the agency accepts the application. The FDA action date is set for April 29, 2017, under the Prescription Drug User Fee Act.
Brigatinib is an oral anaplastic lymphoma kinase (ALK) inhibitor.
“The FDA acceptance of our application is an important milestone in our ongoing efforts to discover, develop and deliver highly innovative treatments for patients with rare cancers,” Paris Panayiotopoulos, president and CEO of Ariad, said in a press release. “We are pleased that our significant R&D investments in brigatinib and our work with the FDA are bringing us closer to potentially offering a treatment option for patients with ALK+ NSCLC who are refractory to crizotinib.”
“We look forward to continuing to work closely with the FDA during the brigatinib NDA review and remain committed to developing critical therapies for unserved and underserved small patient populations suffering from rare cancers,” Panayiotopoulos said.
NSCLC is the most common form of lung cancer, accounting for 85 percent of the nearly 230,000 new cases of lung cancer diagnosed in the U.S. each year, according to the American Cancer Society. Nearly 8 percent of these patients have a rearrangement in the ALK gene, a chromosomal rearrangement that is thought to lead to the development of lung cancer.
Two ALK inhibitors are currently approved in the clinic to treat ALK-positive NSCLC: Xalkori and Zykadia (ceritinib). Researchers have been testing brigatinib, a new ALK inhibitor, for patients who progressed following treatment with Xalkori.
Clinical data from the brigatinib Phase 1/2 trial (NCT01449461) and the pivotal Phase 2 ALTA clinical trial (NCT02094573) show promising results in NSCLC patients, supported Ariad’s NDA submission.
The FDA had already granted Breakthrough Therapy Designation to brigatinib for the treatment of ALK-positive NSCLC patients who progressed on or after Xalkori therapy. Brigatinib also received Orphan Drug Designation by the FDA to treat ALK-positive, ROS1-positive, and EGFR-positive NSCLC.
Ariad is now conducting a randomized, open-label Phase 3 ALTA-1L trial (NCT02737501), evaluating the safety and effectiveness of brigatinib versus Xalkori in patients with advanced NSCLC. The study is currently recruiting participants who have ALK-positive NSCLC who have not been treated with any prior ALK inhibitor.
Ariad is also planning to submit a Marketing Authorization Application, the European NDA equivalent, of brigatinib to the European Medicines Agency in early 2017.
