Seattle Genetics Inc. (SGEN) won U.S. approval to sell the first new drug for Hodgkin lymphoma in more than 30 years.
The drug, Adcetris, also was cleared by the Food and Drug Administration for a rarer cancer known as systemic anaplastic large cell lymphoma or ALCL, the agency said today in a statement. The company said it plans to make the drug available next week.
The medicine, also known as brentuximab, will be Bothell, Washington-based Seattle Genetics’ first commercialized drug. It combines a cancer-targeting antibody with the cell-killing effects of chemotherapy. The drug is the first approved in the U.S. for Hodgkin lymphoma since 1977, the agency said.
“Early clinical data suggest that patients who received Adcetris for Hodgkin lymphoma and systemic anaplastic lymphoma experienced a significant response to the therapy,” Richard Pazdur, director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research, said in the statement.
Sales of the drug may reach $200 million in two years, said Jason Kantor, an analyst with RBC Capital Markets in San Francisco. He called that a conservative estimate and said the market opportunity could be “much bigger.”
“We’re telling people this is a tremendous buying opportunity,” Kantor said today in a telephone interview.
Seattle Genetics gained $1.09, or 7.8 percent, to $15.04 at 4 p.m. New York time in Nasdaq Stock Market composite trading. The shares have gained less than 1 percent this year.
Hodgkin lymphoma will be diagnosed in an estimated 8,830 U.S. patients this year and will cause the death of about 1,300 people, according to the National Cancer Institute in Bethesda, Maryland. The disease begins in the white-blood cells and most commonly strikes people from ages 15 to 35 and older than 55. Symptoms include weight loss, fever and chronic weakness or fatigue.
Adcetris uses so-called antibody-drug conjugate technology developed by Seattle Genetics that targets tumor cells by attaching monoclonal antibodies to cell killing agents.
“The approval of Adcetris is a result of more than a decade of research and development by talented scientists and physicians,” Clay Siegall, Seattle Genetics’ president and chief executive officer, said today in a statement.
The drug’s approval, 11 days ahead of the FDA’s target date, is a surprise to investors who were concerned that negotiations over the drug’s label and postmarketing studies might delay the FDA’s decision, Kantor said.
“People were expecting a very restricted label for who could use the drug,” he said. “The label that they got is, I think, a best-case scenario. This is going to be widely available for relapsed Hodgkin lymphoma and ALCL.”
Systemic anaplastic large cell lymphoma accounts for about 3 percent of all non-Hodgkin lymphoma cases in adults and up to 30 percent in children, according to the nonprofit Lymphoma Research Foundation in New York. The disease can occur in the skin, lymph nodes or organs throughout the body.
The medicine is approved for Hodgkin lymphoma and ALCL patients who have failed previous treatments.
Seattle Genetics has exclusive North American marketing rights to the drug. Takeda Pharmaceutical Co. can sell the drug elsewhere. They share development costs, except in Japan where Takeda has full responsibility.
The FDA evaluated Adcetris under a six-month priority review and aimed to make a decision by Aug. 30. While the FDA typically takes at least 10 months to rule on drug applications, it grants priority status to therapies that may provide major advances in treatment.
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