(Reuters) - Ariad Pharmaceuticals Inc said its experimental lung cancer drug was granted “breakthrough therapy” status by the U.S. Food and Drug Administration and it expected to file for marketing approval in early 2016.
The designation hastens the development and review of a drug that shows evidence of providing improvement over existing treatment for patients with serious diseases.
The drug, AP26113, which is in a mid-stage trial is designed to treat non-small cell lung cancer (NSCLC) with a specific gene mutation.
About 1.5 million cases of NSCLC, the most common form of lung cancer, are diagnosed every year, Ariad said. The company said about 3-8 percent of NSCLC patients have the gene mutation.
The company said it was not looking to partner with any one for the development of the drug.
Ariad said the designation was based on early results that showed the drug continued to fight against lung cancer in patients who did not respond to crizotinib, an approved drug made by Pfizer Inc.
Crizotinib, sold under the name Xalkori, generated $108 million in sales in the second quarter, Pfizer said in a regulatory filing in August.
Roche AG’s alectinib was approved in Japan in July to treat lung cancer with the same gene mutation. [ID:nWEB00P8Q]
Other treatments being developed for the condition are Novartis AG’s Zykadia and Ignyta Inc’s RXDX-101.
Ariad’s shares closed at $5.85 on the Nasdaq on Thursday.
Reporting by Vidya L Nathan and Shailesh Kuber in Bangalore; Editing by Ted Kerr and Kirti Pandey