Seattle Genetics’ drug Adcetris has been put on the fast track to be used as frontline treatment with chemotherapy for patients with advanced classical Hodgkin lymphoma.
The Bothell-based biotech firm was awarded breakthrough-therapy designation for Adcetris by the Food and Drug Administration. The designation is intended to expedite the development and review of promising drugs for serious or life-threatening conditions.
“The decision by the FDA to grant this designation recognizes the need for new options that can change the care of people with newly diagnosed advanced Hodgkin lymphoma,” said Clay Siegall, president and CEO of Seattle Genetics, in a statement.
A new drug to treat advanced classical Hodgkin lymphoma hasn’t been approved for 40 years, according ot the company. Adcetris targets lymphoma cells and delivers a payload to kill the cancer. The key is that the drug is attracted to a protein called CD30.
The breakthrough therapy designation is based on data from a clinical trial. Seattle Genetics reported positive results from the trial in June. Seattle Genetics is expected to present a report on the study at the American Society of Hematology at a meeting in December.
Seattle Genetics stock jumped nearly 8 percent based on the news announced on Monday. The stock was trading at $58.72 a share at the close of day.
Shares of Seattle Genetics have risen 11.3 percent this year, underperforming the industry’s gain of 15.4 percent for the same period, according to Zacks Equity Research.
“We remind investors that Adcetris is currently approved as second- or third-line treatment for classical Hodgkin lymphoma and systemic anaplastic large cell lymphoma after at least one failed multi-agent chemotherapy regimen in the United States as well as Europe,” according to the investment research site.
Also this week, Seattle Genetics and a partner, Takeda, announced that a new study has been published in the journal Blood about positive, long-term survival results on using Adcetris on a type of non-Hodgkin lymphoma.
The five-year study involved 58 patients and, of those, 38 experienced complete remission.