FDA Accepts Supplemental Biologics License Application for Lymphoma Drug

The FDA accepted a supplemental Biologics License Application (BLA) for brentuximab vedotin (Adcetris) to treat patients with cutaneous T-cell lymphoma (CTCL).

The supplemental BLA is based primarily on positive results from the phase 3 ALCANZA trial, which included 128 patients with CTCL in need of systemic therapy.

The primary endpoint of the study was met, with the brentuximab vedotin arm demonstrating a highly statistically significant improvement in the rate of objective response that lasted at least 4 months (ORR4) compared with the control arm.

The ORR4 was 56.3% in the brentuximab vedotin arm compared with 12.5% in the control arm, according to the release.

Key secondary endpoints, which included complete response rate, progression free survival, and reduction in the burden of symptoms during treatment, were highly statistically significant in the brentuximab vedotin arm.

The safety profile was generally consistent with the existing prescribing information, according to the release. The most common adverse events of any grade were anemia, peripheral sensory neuropathy, nausea, diarrhea, fatigue, and neutropenia.

Additional data from 2 investigator-sponsored phase 2 trials have also been incorporated in the supplemental BLA.

“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, chief medical officer and executive vice president of Research & Development at Seattle Genetics, said in the release. “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 4 months with a manageable safety profile. Data from 2 investigator-sponsored trials in a broader patient population were included in the submission to further support Adcetris use in this disease setting.

“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.”

Brentuximab vedotin is an antibody-drug conjugate currently undergoing evaluation in more than 70 ongoing trials, including 4 phase 3 studies, according to the release. The Prescription Drug User Fee Act target action date is set for December 16, 2017.

It is already approved for 3 indications: patients with classical Hodgkin lymphoma after failure or autologous hematopoietic stem cell transplantation (auto-HSCT) or after failure of at least 2 prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates; for classical Hodgkin lymphoma patients at high risk of relapse or progression as post- auto-HSCT consolidation; and for patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least 1 prior multi-agent chemotherapy regimen. The sALCL indication is approved under accelerated approval based on overall response rate, according to the release.