BioCentury
ARTICLE | Clinical News

Incyte reports PML case in Jakafi patient

March 19, 2013 12:42 AM UTC

Incyte Corp. (NASDAQ:INCY) said a 75 year old male with myelofibrosis (MF) who was treated with ruxolitinib in the U.K. Phase II ROBUST trial was diagnosed with progressive multifocal leukoencephalopathy (PML). The company said it has not been determined whether the case of PML was related to the use of ruxolitinib. According to Incyte, the patient -- who experienced neurological symptoms consistent with PML within about one month of starting treatment with twice-daily ruxolitinib last July -- is the only known case of PML in about 9,800 MF patients treated with ruxolitinib in clinical trials or commercially. Despite the symptoms, the patient continued to receive ruxolitinib until about mid-October, when treatment was stopped due to worsening symptoms.

Incyte said it has informed FDA and is in the process of informing investigators in its clinical trials. The company said there are reports in medical literature that suggest that patients with myeloproliferative neoplasms, including MF, may be at higher risk of developing PML. Ruxolitinib's U.S. and EU labels do not mention PML. ...