Ariad finishes rolling NDA for lung cancer; wants sped-up review

Ariad Pharmaceuticals ($ARIA) has finished sending its latest data for brigatinib to the FDA and is now looking to the U.S. regulator for a speedy review.

The Cambridge, MA-based company is seeking a license for brigatinib, its investigational anaplastic lymphoma kinase (ALK) inhibitor, to be used when patients cannot take or are resistant to Pfizer’s ($PFE) marketed ALK non-small cell lung cancer drug Xalkori (crizotinib).

Ariad said in a statement that it is now seeking accelerated approval for brigatinib from the FDA after asking for its coveted priority review, which means it could be on the market around 3 to 4 months earlier than with a normal review. The U.S. regulator has already given the med its “Breakthrough” tag and allowed the rolling status.

“Many patients with ALK-positive non-small cell lung cancer eventually develop disease progression,” said Dr. Corey Langer, director of thoracic oncology in the Abramson Cancer Center of the University of Pennsylvania and a professor of hematology-oncology in Penn’s Perelman School of Medicine.

“We are excited that the brigatinib NDA submission is now complete and are hopeful that brigatinib’s data, including the observation of complete responses and activity in the central nervous system, will provide patients and their oncologists with a new treatment option.”

The NDA submission includes data from its Phase I/II and pivotal Phase II ALTA trials of brigatinib. In the ALTA trial, patients who suffered from disease progression on Xalkori were randomized to one of two brigatinib regimens.  

With a median follow-up of 8.3 months, 54% of patients treated with 180 mg with a one-week lead-in at 90 mg achieved an investigator-assessed confirmed objective response--the trial’s primary endpoint. In this arm, median progression-free survival was just over a year.  

“With the completion of the brigatinib submission this week, we are excited by its potential, if approved, to offer additional hope to patients and their families,” stated Paris Panayiotopoulos, president and chief executive officer of Ariad. “We are thankful to the patients and physicians who participated in the clinical trials of brigatinib. We remain grateful to the FDA for granting brigatinib a breakthrough designation and the benefit of a rolling submission process, unique to the U.S. regulatory system.”

Ariad said it plans to submit brigatinib to the EMA in “early 2017.” Xalkori, which has several U.S. lung cancer licenses, made $488 million last year--up 11% on 2014.

The company hopes to have a better second half to 2016 after announcing back in March that it was axing about 90 staffers--25% of its total workforce--in an ongoing restructuring of the business.

The biotech said it was also reviewing its R&D portfolio and other aspects of the business. This did not however impact its work on brigatinib, which remains a primary focus. This also came after Ariad laid off around 40% of its staff in 2013 when it was forced to yank its leukemia drug off the market.