Cell Therapeutics, Inc. ("CTI") (NASDAQ and MTA: CTIC) announced today that Pixuvri™ (pixantrone dimaleate) has been granted a positive opinion for conditional approval from the European Medicines Agency's ("EMA") Committee for Medicinal Products for Human Use ("CHMP"). Based on the CHMP's recommendation, CTI expects that a conditional marketing authorization for Pixuvri should be granted by the European Commission within the next few months. CHMP recommended Pixuvri for conditional approval as monotherapy for the treatment of adult patients with multiple relapsed or refractory aggressive non-Hodgkin B-cell lymphomas ("NHL").
If the CHMP's recommendation is formally adopted by the European Commission, Pixuvri would be approved for marketing in the 27 countries that are members of the E.U., as well as the European Economic Area. The decision by the European Commission is typically issued approximately two to three months after the CHMP opinion and generally follows the recommendation from the CHMP. If the opinion is confirmed by the European Commission, Pixuvri would be the first drug approved for patients in this setting.
"We are very pleased with the CHMP's positive recommendation recognizing the clinical benefit of Pixuvri in addressing a significant unmet medical need for patients with multiple relapsed or refractory aggressive B-cell NHL, and we believe that Pixuvri will add an important treatment option for physicians and provide a meaningful impact on patients," stated James A. Bianco, CEO of CTI.
"There are currently no proven effective therapies for these advanced NHL patients. Our goal for this late stage patient population is to control disease progression and symptoms as a cure is no longer an option. We are encouraged by the PFS noted in the PIX301 study and the opportunity this agent provides in treating this difficult to treat group of patients," said Bertrand Coiffier, M.D., Ph.D., Professor of Hematology at the Department of Hematology, Hospices Civils de Lyon and the University Lyon 1 in Lyon, France.
Similar to accelerated approval regulations in the United States, conditional marketing authorizations are granted to medicinal products with a positive benefit/risk assessment that address unmet medical needs and whose availability would result in a significant public health benefit. A conditional marketing authorization is renewable annually. Under the provisions of the conditional marketing authorization for Pixuvri, CTI will be required to complete a post-marketing study aimed at confirming the clinical benefit previously observed.
The CHMP has accepted PIX306, CTI's ongoing randomized controlled phase 3 clinical trial, which compares Pixuvri-rituximab to gemcitabine-rituximab in 2nd line patients with aggressive B‑cell NHL who failed front-line CHOP-R and who are not eligible for autologous stem cell transplant ("ASCT") or as 3rd or 4th line therapy in aggressive B-cell NHL. As a condition of approval, CTI has agreed to have available the PIX306 clinical trial results by June 2015.
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