Incyte Files for U.S. Approval of Cancer Drug - Drug Discovery and Development

NEW YORK (AP) – Incyte Corp. filed for marketing approval of its lead drug candidate ruxolitinib, and has asked regulators to make a decision on the cancer treatment by early December.

The company said on June 6 that it asked the FDA to approve ruxolitinib as a treatment for myelofibrosis, a cancer of the blood. Incyte requested a priority review, and if the FDA grants that review, it will return a decision in six months instead of the usual 10 months. Priority reviews are given to drugs that treat diseases with limited or no treatment options, and Incyte said there are no drugs approved to treat myelofibrosis.

Novartis AG, Incyte’s partner on the drug, has said it will file for approval in the European Union by the end of June.

The company also reported new data from late-stage trials of ruxolitinib at the American Society of Clinical Oncology conference earlier this month. Analysts said on June 7 that the details are encouraging: Anemia has been one of the most common side effects of ruxolitinib in clinical trials, but Incyte said the rates of severe anemia went down over time. After 24 weeks of treatment, patients on ruxolitinib were about as likely to have severe anemia as patients who were only receiving standard treatments.

Thomas Wei, a Jefferies & Co. analyst, said the rates of anemia are high, but patients who were treated with ruxolitinib were less likely to need blood transfusions than other patients. He added that patients who had severe anemia still had strong improvement in their symptoms.

The initial results from the trials were reported in December and March.

The Associated Press