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WASHINGTON (Reuters) - U.S. drug regulators gave the go ahead on Friday for a blood cancer medicine by Seattle Genetics Inc, making it the first drug for Hodgkin's lymphoma approved in more than 30 years.
The U.S. Food and Drug Administration granted accelerated, or conditional, approved Seattle Genetics' Adcetris (brentuximab vedotin) to treat Hodgkin's lymphoma and anaplastic large cell lymphoma (ALCL), ahead of the deadline for the decision on the drug.
The approval was for use in Hodgkin's patients whose have already received a stem cell transplant, or after two chemotherapy treatments in patients who couldn't have a transplant, and in ALCL patients who have gone through one chemotherapy treatment.
This is the first drug approved for Hodgkin's lymphoma since 1977 and the first one ever specifically indicated to treat ALCL. About 9,000 Americans a year are diagnosed with Hodgkin's lymphoma and 3,000 with ALCL.
The FDA, which was due to decide on Adcetris by Aug. 30, granted priority review status for the drug, meaning the agency believes the medicine is a potentially significant advance over existing therapies.
The FDA said the effectiveness of Adcetris in Hodgkin's lymphoma was evaluated in a single-arm trial involving 102 patients. Seventy-three percent of patients achieved either a complete or partial response to the treatment. The mean duration of response was 6.7 months.
The drug's effectiveness in systemic ALCL was evaluated in a single-arm study in 58 patients. In this trial, 86% of participants had either a complete or partial response, with the average response lasting 12.6 months.
The most common side effects were neutropenia, peripheral sensory neuropathy, fatigue, nausea, anemia, upper respiratory infection, diarrhea, fever, cough, vomiting, and thrombocytopenia.
Seattle Genetics is now conducting more trials to both satisfy the FDA requirement for full approval after such accelerated, or conditional, approval and to reach its own goal of getting Adcetris to more patients and earlier in their treatment.
"We are focused on broadening out the use of Adcetris to bigger patient populations and bringing it to front line treatment," the company's Chief Executive Clay Siegall told Reuters.
Adcetris is an antibody-drug conjugate; the antibody directs the drug to CD30 on lymphoma cells.
Seattle Genetics said it planned to begin selling Adcetris next week. Siegall would not disclose the price of the drug, which is expected to be revealed in a company conference call on Aug. 22. J.P. Morgan analyst Cory Kasimov expected a price range per patient of $100,000 to $150,000.
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