As expected, regulators in the USA have rejected Cell Therapeutics’ bid to get the green light for its non-Hodgkins lymphoma drug Pixuvri.
The US Food and Drug Administration has issued the company with a complete response letter for Pixuvri (pixantrone) as a treatment for patients with relapsed or refractory aggressive NHL. The agency says the decision reflects “concerns previously raised” at its Oncologic Drugs Advisory Committee meeting in March 22, 2010 which voted 9-0 against recommending approval and stated that the company should conduct an additional trial to demonstrate the safety and effectiveness of the product.
However, Cell Therapeutics is not giving up yet, saying it will meet with the FDA to discuss the design of the follow-on study and the firm expects to submit Pixuvri to regulators in Europe in the third quarter this year. The company quoted a cancer specialist, Stanley Marks, chief medical officer at the University of Pittsburgh Cancer Centers, as saying that “I was disappointed that an agency charged with providing treatment hope for patients with life-threatening diseases like relapsed/refractory NHL would ignore clinically meaningful improvements in overall response rate and progression-free survival, let alone complete responses”.
Observers doubt Cell Therapeutics has the funds to finance a new study and claim it desperately need to raise some cash. On Friday, it put back a special meeting of shareholders to May 14, when investor will be asked to back the board’s plan to sell up to 1.2 billion shares.
Meantime, Cell Therapeutics stated in a filing to the US Securities Exchange Commission that it “has no comment on the reports of a potential takeover” by Novartis, but confirmed that the companies are in talks regarding the development of Pixuvri.
