WASHINGTON 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 Food and Drug Administration approved Seattle Genetics' Adcetris to treat two types of relatively rare blood cancers -- Hodgkin's lymphoma and anaplastic large cell lymphoma (ALCL) -- with a broader label than expected and ahead of the deadline for the decision on the drug.
Adcetris received approval for use in Hodgkin's patients whose have already received a stem cell transplant or two chemotherapy treatments 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 National Cancer Institute estimates some 1,300 people will die of Hodgkin's lymphoma in the United States this year alone.
In July, a panel of FDA advisers raised questions about the drug's trial size and spooked Wall Street with the possibility the label could be restricted to Hodgkin's lymphoma patients whose illness relapsed after a stem cell transplant.
"There was growing concern that (Seattle Genetics) and FDA would not have time to agree on post marketing trials and negotiate a label in the short time since the (panel) meeting or that (Seattle Genetics) would lose negotiating leverage in its attempt to get an improved label," RBC Capital Markets analyst Jason Kantor said in a note.
"The early approval and broad label clearly remove those overhangs and should restore confidence in (Seattle Genetics)management."
The FDA, which was due to decide on Adcetris by August 30, granted priority review status for the drug, meaning the agency believes the medicine is a potentially significant advance over existing therapies.
The company 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.
"Overall, we are delighted with the label ... This is a label that is the best outcome for patients that need Adcetris," he said.
Seattle Genetics shares rose 7.8 percent to close at $15.04 on Nasdaq.
Adcetris, known chemically as brentuximab vedotin, 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, or foreign substance, in Hodgkin's lymphoma, several types of T-cell lymphoma and other hematologic malignancies.
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 August 22. J.P. Morgan analyst Cory Kasimov expected a price range per patient of $100,000 to $150,000.
Howard Liang, an analyst at Leerink Swann, has forecast that U.S. sales of Adcetris could reach more than $400 million for both Hodgkin's and ALCL in 2015.
"At some point in the future, we'll consider providing sales guidance," Siegall said, declining to give any forecasts at this time.