Cell Therapeutics' request to expand approved uses for cancer drug Zevalin will get a fast-track review from federal regulators.
Cell Therapeutics said Monday that its request to expand approved uses for cancer drug Zevalin will get a fast-track review from federal regulators.
The U.S. Food and Drug Administration granted priority review to Zevalin, which the Seattle biotech company wants to market as a second-round therapy for non-Hodgkins’ lymphoma patients who responded well to their initial treatment.
The radio-immunotherapy is currently approved to treat patients with relapsed or refractory non-Hodgkin’s lymphoma, a much smaller group.
The FDA said it would aim to make a decision by April 2, a much shorter period of time than the 10 months it usually takes for biotech products to navigate the regulatory review process.
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Cell Therapeutics, which has struggled to launch its own pipeline of cancer therapies since it was created in 1991, bought Zevalin from Biogen Idec last December, thinking the drug had unrealized market potential.
Some 1,000 patients currently use the therapy, generating some $15 million in revenue for the company. If the FDA’s sped-up review results in a new approved usage, some 18,000 patients could use the drug, the company said.
Last week, Cell Therapeutics said it will split Zevalin’s profits with Spectrum Pharmaceuticals, a California company, in exchange for $15 million in the near term and up to $15 million in milestone payments.
Ángel González: 206-515-5644 or firstname.lastname@example.org