Cell Therapeutics, Inc. has announced that it has received conditional marketing authorization from the European Commission (“EC”) for Pixuvri® (pixantrone) as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphomas (“NHL”).
Pixuvri is the first approved treatment in the European Union (“EU”) in this patient setting.
The decision allows CTI to market Pixuvri in the 27 Member States of the EU as well as in Iceland, Liechtenstein and Norway.
CTI expects to make Pixuvri immediately available in the EU, initially through a named patient program. CTI plans to market and commercialize Pixuvri with its own sales force in the EU starting in the 2nd half of 2012.
“Pixuvri is a welcome addition in our efforts to control disease progression in these late-stage aggressive NHL patients as it has demonstrated a significant benefit compared to standard treatments used at this stage of disease. By addressing this unmet need, Pixuvri adds an important treatment option for patients,” said Ruth Pettengell, M.D. of St. George’s Hospital, University of London, the lead investigator for the PIX 301 trial.
“The EC’s decision for Pixuvri is an important milestone for adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphomas who currently have no approved option to treat their disease, and we are moving rapidly to make this product available for patients in the EU,” said James A. Bianco, M.D., CEO of CTI.
The PIX 301 phase 3 clinical trial, which formed the basis for the marketing authorization application, demonstrated that a greater proportion of patients achieved a complete response or unconfirmed complete response to Pixuvri than a comparator chemotherapy medicine, (20% versus 6%) and patients receiving Pixuvri survived for longer without their disease progressing (an average of 10.2 months versus 7.6 months).
The most frequent side effect seen in the clinical studies was suppression of the patient’s bone marrow, resulting in low levels of white blood cells, platelets and red blood cells. Infections were common, but were only serious in a few patients.
The Summary of Product Characteristics (“SmPC”) will include the full prescribing information, including the safety and efficacy profile of Pixuvri in the approved indication.
The Summary of Product Characteristics, which will be published in the European Public Assessment Report is expected to be posted to the European Medicines Agency’s (the “EMA”) website (http://www.ema.europa.eu) in the next few weeks.
Indication and Dosing
Pixuvri will be marketed in the EU as Pixuvri 29 mg powder for concentrate for solution for infusion; and is indicated as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive NHL.
The benefit of Pixuvri treatment has not been established in patients when used as fifth line or greater chemotherapy in patients who are refractory to last therapy.
One vial of Pixuvri contains 29 mg pixantrone (as dimaleate), and must be reconstituted and diluted before use. The recommended dose is 50 mg/m2 of Pixuvri base on days one, eight, and 15 of each 28 day cycle for up to six cycles.
However, the dose has to be adjusted before the start of each cycle based on nadir hematologic counts or maximum toxicity from the preceding cycle of therapy.
The amount of Pixuvri in milligrams that is to be administered to a patient should be determined on the basis of the patient’s body surface area (“BSA”).