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FDA Accepts Spectrum’s Response On Its Cancer Drug, Shares Soar

Shares of Irvine-based Spectrum Pharmaceutical Inc. closed up 6 percent Monday after the Food and Drug Administration (FDA) accepted an application for review of the company’s response on a new use for its cancer drug, Zevalin. Spectrum’s plea has been accepted as a Class 1 submission, which means the regulators would review the drug within 60 days.

Spectrum is seeking the approval to expand the use of Zevalin to treat more patients with non-Hodgkin’s lymphoma (NHL,) a blood disease. Earlier this month, the FDA had asked for more clinical trial information on the drug maker’s application for the approval.

Zevalin is already approved as treatment for patients with more advanced forms of non-Hodgkin’s lymphoma, with relapse or refractory and who have been treated previously with other drugs. But, Spectrum hopes to see the drug approved as an early treatment for the disease. The U.S. health regulators is expected to deliver its decision on the drug on September 7.

Reportedly, Spectrum Pharmaceutical Inc. is the fourth company to own Zevalin since it was approved in 2001. The drug’s previous owners include Idec Pharmaceuticals; the former’s successor, Biogen Idec Inc. – Cambridge, Massachusetts; and Seattle-based Cell Therapeutics Inc.

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