Seattle Genetics (NASDAQ: SGEN) passed its first big test with an FDA advisory panel today with flying colors. An FDA panel of cancer drug experts recommended in a 10-0 vote that the company’s drug for Hodgkin’s lymphoma should be cleared for sale in the U.S.
The vote came this morning by the FDA’s Oncologic Drugs Advisory Committee, which gathered in Silver Spring, MD to review the safety and effectiveness of brentuximab vedotin (Adcetris). The panel is also meeting later today to discuss another use of the drug for another rare disease, anaplastic large cell lymphoma.
The FDA isn’t required to follow the advice of its advisory panels, but it usually does. The agency’s deadline to complete its review of the Seattle Genetics drug is August 30. But there was no real debate about the drug’s safety and effectiveness profile. A study of 102 patients showed that 75 percent had complete or partial tumor shrinkage, which lasted a median time of 6.7 months, even after patients failed all prior rounds of therapy.
About 8,500 patients get Hodgkin’s disease each year in the U.S. and about two-thirds are cured with standard chemotherapies, but the rest eventually relapse.
“Brentuximab works and it works well. People with Hodgkin’s lymphoma will have another option for treating a terrible disease,” said Mikkael Sekeres, an oncologist at the Cleveland Clinic, in explaining his vote at the public hearing.
Wyndham Wilson, the chairman of the panel and a cancer researcher at the National Cancer Institute, added that “this drug has extremely exciting activity.” Even the often critical head of the FDA’s cancer drug officer, Richard Pazdur, said “we think this is an active drug and would like to see it out and available for the American public.”
Questions at the panel centered on issues like what further trials will be necessary to confirm the benefit of the drug, which patient populations it is most appropriate for, and its long-term safety profile. The most common adverse event was peripheral neuropathy, a form of nerve damage in the fingers and toes, which researchers said could be managed by reducing the dose.
If the FDA approves the drug for sale, it will be Seattle Genetics’ first marketed product after 14 years in business and more than $500 million of investment. It will also have a chance to be the first commercially successful version of an “empowered antibody” which combines the targeting ability of an antibody with a toxin to give it extra tumor-killing punch.