European Commission Approves CTI's Pixantrone

In a stunning decision, the EC has granted conditional marketing authorization to Cell Therapeutics' Pixurvi (pixantrone) for use as monotherapy in the treatment of adults with multiply-relapsed or refractory aggressive B-cell non-Hodgkin's lymphomas (NHL).

The firm says it will make the drug available in the EU immediately, although it will begin through a named patient basis.

Being 'conditional approval' means that CTI will be required to 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. CTI says it will have trial results available to the European Medicines Agency by mid-2015.

Pixurvi is is an aza-anthracenedione formulated for IV injection. According to CTI, Pixurvi has the efficacy of an anthracycline; however, it doesn't bind iron and propagate oxygen radical production or form long-lived hydroxyl metabolites--the mechanisms believed to be behind the cardiotoxicity associated with other anthracycline drugs.

According to the US FDA, this claim is not supported by the clinical data.

CTI, which withdrew an application to the FDA in January, says it will re-submit one later in 2012.

Source: MarketWatch