Pixuvri Gains Conditional Approval from EU Commission
Cell Therapeutics has obtained conditional approval in Europe for their lymphoma drug, Pixuvri.
The European Commission has given the okay for Pixuvri (pixantrone) as monotherapy for the treatment of adults with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphomas (NHL), making it the first authorised treatment in this patient setting in the continent. The decision covers the 27 EU member states, in addition to Liechtenstein, Iceland and Norway.
The approval is centred on the PIX 301 Phase III clinical trial which proved that a greater percentage of patients achieved a complete response or unconfirmed complete response to Pixuvri than a comparator chemotherapy (20% versus 6%) and patients on the medication lived longer without the disease developing, with patients taking the drug having an average of 10.2 months in comparison to 7.6 months.
The most common side effect from the study was suppression of the patient’s bone marrow, which resulted in low levels of white blood cells, platelets and red blood cells. Although infections were common, they were only severe in a few patients.
Cell Therapeutics will initially market the drug through a named patient programme and the conditional marketing authorisation. As part of the approval, the company will be required to complete a post-marketing study “aimed at confirming the clinical benefit previously observed.”
“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,” commented James A. Bianco, CEO of Cell Therapeutics.
The approval is a big boost for Cell Therapeutics, which withdrew their New Drug Application (NDA) from the US in January. In April 2010, the Food and Drug Administration (FDA) delivered a complete response letter to Cell Therapeutics noting that they should conduct an additional clinical trial on Pixuvri, and a month earlier, the agency’s Oncologic Drugs Advisory Committee voted 9-0 against recommending approval of the drug.
“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” noted Norbert Schmitz, Head of the Department of Hematology, Askelepios Klinik St. Georg in Germany.
Cell Therapeutics will market Pixuvri with its own sales force in Europe starting in the second half.