The U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) required to bring Seattle Genetics’ Adcetris (brentuximab vedotin) to the market for the treatment of cutaneous T-cell lymphoma (CTCL).
The FDA will take action on the application, which has received priority review status, no later than Dec. 16, 2017.
“The FDA’s filing of our supplemental BLA with Priority Review status represents a significant milestone towards our goal of making Adcetris available to CTCL patients who require systemic therapy,” Jonathan Drachman, MD, said in a press release. Drachman is chief medical officer and executive vice president of research and development at Seattle Genetics.
The application was based mainly on data from the ALCANZA Phase 3 trial (NCT01578499), which were published in June 2017. In addition, the application included data from two investigator-sponsored Phase 2 studies.
The Alcanza trial showed that Adcetris-treated patients with CTCL had an objective response rate, lasting at least four months, of 56.3%. Those treated with standard treatments — methotrexate or bexarotene — had a response rate of 12.5% in the same period.
Adcetris also improved complete response rates and progression-free survival, and reduced symptom burden.
The study included 128 patients who tested positive for the cancer surface marker CD30, which is the most common type of CTCL.
Safety of the treatment was similar to that previously recorded and included in the prescription label for Adcetris.
“Results from our positive phase 3 ALCANZA trial demonstrated that using Adcetris in this setting significantly improved the rate of objective responses lasting at least four months with a manageable safety profile,” said Drachman.
“Data from two investigator-sponsored trials in a broader patient population were included in the submission to further support Adcetris use in this disease setting,” he added. “We look forward to working with the FDA during the review of our application for Adcetris in CTCL, which, if approved, would be the fourth indication for this product.”
The drug, which Seattle Genetics develops in collaboration with Takeda Pharmaceutical, was granted breakthrough therapy designation by the FDA in November 2016 for the treatment of CD30-expressing mycosis fungoides and primary cutaneous anaplastic large cell lymphoma — the two most common CTCL subtypes.
Adcetris already is approved in the U.S and Canada for certain patients with classical Hodgkin lymphoma and systemic anaplastic large cell lymphoma. In Europe, Adcetris is approved for CD30-positive Hodgkin lymphoma.