The U.S. Food and Drug Administration has granted Adcetris (brentuximab vedotin) Breakthrough Therapy Designation as a treatment with chemotherapy for patients with previously untreated advanced classical Hodgkin lymphoma.
The designation, awarded only to investigational drugs for serious or life-threatening diseases, will speed up the development and regulatory review of the medication.
“This designation recognizes the need for new options that can change the care of people with newly diagnosed advanced Hodgkin lymphoma,” Clay Siegall, president and chief executive officer of Seattle Genetics, said in a press release. It “supports our goal to make Adcetris available to patients in this setting as soon as possible.”
The FDA granted breakthrough status to the Adcetris and chemotherapy combination after the Phase 3 ECHELON-1 trial (NCT01712490) demonstrated that patients receiving Adcetris survived longer without their disease progressing, a measure researchers called modified progression-free survival.
The study, which included 1,334 patients, showed that at two years, 82.1 percent of Adcetris-treated patients were still alive without their disease progressing or needing further treatment. Among patients in the control group, who received standard of care chemotherapy, the figure was 77.2 percent.
Adcetris also increased patients’ overall survival rates, researchers said.
“The phase 3 ECHELON-1 study that supports the Breakthrough Therapy Designation for Adcetris in combination with chemotherapy showed superior activity versus the standard of care chemotherapy regimen in the treatment of frontline advanced classical Hodgkin lymphoma patients,” Siegall said.
Researchers will present the full trial data at the American Society of Hematology Annual Meeting, in Atlanta, Dec. 9-12.
“We look forward to presenting the data from our phase 3 ECHELON-1 trial at the upcoming ASH annual meeting and intend to submit a supplemental Biologics License Application to the FDA before the end of 2017,” Siegall said.
Adcetris consists of an anticancer drug linked to an antibody that targets the CD30 protein. Since CD30 is found on lymphoma cells, the antibody-drug conjugate can kill those cells.
The FDA has approved Adcetris for classical Hodgkin lymphoma patients who relapse after treatment. It has also approved it as a consolidation treatment for patients at risk of a relapse. But the agency has yet to approve it as a first-line treatment for these patients.
In addition, the drug is approved for relapsed systemic anaplastic large cell lymphoma (sALCL). And researchers are examining it in more than 70 clinical trials of various cancer types.