11. May 2012 15:39
Cell Therapeutics has gained conditional authorisation from the European Commission to market its treatment for non-Hodgkin’s B-cell lymphoma.
The US biopharma company will be able to market Pixvuri (pixantrone) through a named patient programme in the EU.
This type of authorisation allows a company to quickly market a drug that addresses a major unmet medical need, while waiting for full approval.
According to Cell Therapeutics, the decision follows a phase III clinical trial that showed Pixvari to offer longer progression-free survival and a higher rate of complete response than chemotherapy.
Cell Therapeutics plans to commercialise Pixvari in Europe in the second half of 2012, and will need to complete a post-marketing study to confirm the drug’s clinical efficacy.
The EC decision is a breakthrough for the product, which was rejected by the FDA in 2011 on the grounds that its benefits were unproven. The company is preparing for a second FDA committee review.