Cell Therapeutics says that regulators in the USA have granted a priority review for expanded use of its radioimmunotherapy treatment Zevalin.
The US Food and Drug Administration has granted fast-track status to the firm’s supplemental Biologics License Application for use of Zevalin ([90Y]-ibritumomab tiuxetan) as consolidation therapy for patients with follicular B-cell non-Hodgkin’s lymphoma who achieve a response to first-line therapy. A Prescription Drug User Fee Act target date of April 2, has been set for a decision on the sBLA and if approved, Zevalin would be the first radioimmunotherapy available to patients as first-line consolidation therapy.
Cell Therapeutics’ chief executive James Blanco says that by granting the application priority review status, the FDA acknowledges that the use of Zevalin in the first-line consolidation setting “could represent an important treatment option for follicular B-cell NHL patients”. The decision shortens the timeframe for FDA review from ten to six months, and also pushes up the commercial launch for first-line indication by four months “which should result in a substantial increase to our revenue forecast in 2009,” he said.
Cell Therapeutics has set up a 50/50 joint venture with Spectrum Pharmaceuticals, called RIT Oncology, to commercialise and develop Zevalin in the USA. The former acquired the US rights to the drug from Biogen Idec in December last year and gained access to the First-line Indolent Trial (FIT) data through an agreement with Bayer; the latter firm used that data to obtain approval for Zevalin as first-line consolidation treatment in Europe in April.
Zevalin is currently approved in the USA for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell NHL, including patients with rituximab refractory follicular NHL. It is also indicated, under accelerated approval, for the treatment of relapsed or refractory, rituximab-naive, low-grade and follicular NHL.
Cell Therapeutics estimates that there would be approximately 18,000 additional patients that currently receive first-line treatment which would potentially be eligible to use Zevalin under the proposed expanded label.
