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Seattle Genetics drug gets priority FDA review
May 2, 2011 / 10:46 AM / 6 years ago

Seattle Genetics drug gets priority FDA review

* 6-month review for experimental lymphoma drug

* FDA set to decide on application by Aug. 30

LOS ANGELES, May 2 (Reuters) - The U.S. Food and Drug Administration will review a Seattle Genetics Inc (SGEN.O) experimental drug for two types of lymphoma on a priority basis, the company said on Monday.

Under this six-month review, the FDA is scheduled to decide by Aug. 30 whether to approve the drug, brentuximab vedotin, as a treatment for patients with either Hodgkin’s lymphoma or anaplastic large cell lymphoma (ALCL) who have stopped responding to other therapies.

Seattle Genetics said the agency will act individually on the application for each indication.

Clay Siegall, chief executive officer at Seattle Genetics, estimated that 8,000 to 9,000 U.S. patients would be eligible for treatment with brentuximab vedotin if approval is granted.

The drug, which is being developed in a partnership with Japan’s Takeda Pharmaceutical Co Ltd (4502.T), links a tumor-targeting antibody to a cancer-killing chemotherapy drug with the goal of limiting side effects. It is designed to home in on an antigen expressed in Hodgkin’s lymphoma, several types of T-cell lymphoma and other hematologic malignancies.

Analysts, on average, have projected that the brentuximab vedotin will reach annual sales of $262 million by 2015, according to Thomson-Pharma.

Seattle Genetics is also studying the drug as an initial treatment for Hodgkin’s lymphoma and ALCL, as well as in other types of lymphoma. (Reporting by Deena Beasley; editing by Andre Grenon)

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