With promising Ph3 data in hand, Incyte files for myelofibrosis drug OK

Hot on the heels of detailing promising pivotal data on ruxolitinib, Incyte ($INCY) filed for FDA approval of the myelofibrosis drug.

On Saturday investigators for Incyte and Novartis reported that the experimental drug (INC424) hit another Phase III endpoint, reducing spleen size in patients with myelofibrosis, a blood cancer. After 48 weeks of treatment researchers noted a 35 percent reduction in spleen size by slightly more than a quarter of the patients taking the drug. None of the patients taking standard treatment responded to treatment. Anemia was the primary side effect.

"Anemia is dependent on the dose of drug used, so it can be easily managed with a reduction of the dose whenever necessary," study co-author Dr. Alessandro Vannucchi told Reuters. "This is really an exciting drug in this field...I am very convinced that it will be an important chance for these patients."

Two phase III studies--COMFORT-I and COMFORT-II--were conducted as part of the Incyte-Novartis worldwide collaboration and license agreement for ruxolitinib, an JAK1 and JAK2 inhibitor.

"In its entirety, the efficacy data from COMFORT-I and COMFORT-II have the potential to establish ruxolitinib as a new therapeutic approach by decreasing splenomegaly, itself associated with significant morbidity, and improving the symptoms that have such a profound impact on the quality of life for patients with myelofibrosis," said Srdan Verstovsek, the principal investigator for COMFORT-I. "By contrast, patients treated with placebo or best available care experienced progressive splenomegaly and symptomatology."

- see the Incyte release on the regulatory filing
- here's the release on the Phase III data
- check out the Reuters story