Firm will immediately make drug available, initially on a named-patient basis.
The EC granted Cell Therapeutics’ Pixuvri® (pixantrone) conditional marketing authorization for use as monotherapy in the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphomas (NHL). The firm says it will make the drug available in the EU immediately, initially through a named patient basis.
Conditional approval of Pixuvri was granted on the basis of Cell Therapeutics’ Phase III PIX 301 study, which showed that 20% of patients treated using the drug achieved a complete response or unconfirmed complete response, compared with 6% of patients treated using a comparator chemotherapy. In addition, average progression-free survival was 2.6 months longer among Pixuvri-treated patients, at 10.2 months.
Under terms of the conditional marketing approval, Cell Therapeutics will complete a post-marketing study to confirm the clinical benefits of Pixuvri. The EMA’s Committee for Medicinal Products for Human Use will also accept for review data from an ongoing Phase III trial, PIX306, which is comparing Pixuvri-rituximab to gemcitabine-rituximab in relapsed patients with aggressive B-cell NHL who aren’t eligible for autologous stem cell transplantation. The firm will make the trial results available to the European Medicines Agency by mid-2015.
Pixantrone is an aza-anthracenedione formulated for delivery via a peripheral intravenous catheter. Cell Therapeutics claims the drug demonstrates structural and physicochemical properties that mean it doesn’t to bind iron and propagate oxygen radical production or form long-lived hydroxyl metabolites, which are the mechanisms believed to be responsible for induced acute and chronic cardiotoxicity associated with other anthracycline drugs. These benefits mean pixantrone can be administered to patients over the long term, without unacceptable cardiotoxicity risks.
In January Cell Therapeutics voluntarily withdrew its NDA for Pixuvri in the U.S., due, it says, to a lack of time to prepare for FDA’s Oncologic Drugs Advisory Committee review of the drug in advance of the Prescription Drug User Fee Act (PDUFA) date, which had been set for April 24. The firm plans to re-submit the NDA later in 2012.