publication date: Jan. 23, 2015

CHMP Grants Positive Opinion to Jakavi in Polycythemia Vera


The Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion for Jakavi (ruxolitinib) for the treatment of adult patients with polycythemia vera who are resistant to or intolerant of hydroxyurea. If approved in the EU, ruxolitinib could provide the first targeted treatment option for these patients.

In PV, patients with resistance to or intolerance of hydroxyurea are considered to have uncontrolled disease, which is typically defined as hematocrit levels greater than 45 percent, elevated white blood cell count and/or platelet count, and may be accompanied by debilitating symptoms and/or enlarged spleen.

The European Commission delivers its final decision within three months of the CHMP recommendation. The decision will be applicable to all 28 EU member states plus Iceland, Norway and Liechtenstein. Global regulatory applications for ruxolitinib in PV are currently ongoing, and further regulatory filings are under review by health authorities. Ruxolitinib, which is marketed in the U.S. by Incyte Corporation as Jakafi, received approval in December 2014 from FDA for the treatment of patients with PV who have had an inadequate response to or are intolerant of hydroxyurea.

The CHMP recommendation was based on results from the phase III RESPONSE clinical trial demonstrating that a significantly greater proportion of patients achieved the composite primary endpoint of hematocrit control (volume percentage of red blood cells in whole blood) without use of phlebotomy (a procedure to remove blood from the body to reduce the concentration of red blood cells) and spleen size reduction when treated with ruxolitinib compared to best available therapy (21 percent compared to 1 percent, respectively; p<0.0001).

In addition, a greater proportion … Continue reading 41-03 CHMP Grants Positive Opinion To Jakavi in Polycythemia Vera

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