Seattle Genetics (SGEN) Granted FDA Breakthrough Therapy Designation for ADCETRIS

November 10, 2016 8:07 AM EST

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Seattle Genetics, Inc. (Nasdaq: SGEN) announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to ADCETRIS (brentuximab vedotin) for the treatment of patients with CD30-expressing mycosis fungoides (MF) and primary cutaneous anaplastic large cell lymphoma (pcALCL) who require systemic therapy and have received one prior systemic therapy. MF and pcALCL are the most common subtypes of cutaneous T-cell lymphoma (CTCL), accounting for more than 75 percent of the disease. ADCETRIS has been evaluated in CD30-expressing CTCL in investigator- and corporate-sponsored clinical trials, including the phase 3 ALCANZA study. The positive topline results of the ALCANZA trial were announced in August 2016 and an abstract was accepted for oral presentation at the upcoming American Society of Hematology (ASH) annual meeting, December 3-6, 2016 in San Diego, California. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30 which is expressed on skin lesions in approximately 50 percent of patients with CTCL. ADCETRIS is currently not approved for the treatment of CTCL.

The FDA’s Breakthrough Therapy Designation is intended to expedite the development and review of promising drug candidates for serious or life-threatening conditions. It is based upon clinical evidence of substantial improvement over existing therapies on one or more clinically significant endpoints.

“The decision by the FDA to grant ADCETRIS Breakthrough Therapy Designation further reinforces our belief that ADCETRIS represents a meaningful advance in the treatment of CD30-expressing CTCL,” said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “The Breakthrough Therapy Designation supports our goal to expedite the review and approval process to make ADCETRIS available to patients in this setting who may benefit. We look forward to presenting the data from our phase 3 ALCANZA trial in an oral session at the upcoming ASH annual meeting and intend to submit a supplemental Biologics License Application to the FDA in the first half of 2017 for approval in this setting.”

This Breakthrough Therapy Designation was based on data from the phase 3 ALCANZA clinical trial. The phase 3 ALCANZA trial evaluated ADCETRIS in CD30-expressing CTCL and met its primary endpoint, demonstrating a highly statistically significant improvement in the rate of objective response lasting at least four months (ORR4). This randomized trial, which received a Special Protocol Assessment (SPA) agreement from the FDA and scientific advice from the European Medicines Agency (EMA), compared the use of single-agent ADCETRIS to a control arm of investigator’s choice of standard therapies, methotrexate or bexarotene, in 131 patients with CD30-expressing CTCL who received prior systemic or radiation therapy.

The title of the phase 3 ALCANZA abstract accepted for oral presentation at the ASH Annual Meeting is below and can be found at

  • Brentuximab Vedotin Demonstrates Significantly Superior Clinical Outcomes in Patients with CD30-Expressing Cutaneous T Cell Lymphoma Versus Physician's Choice (Methotrexate or Bexarotene): the Phase 3 ALCANZA Study (Abstract #182, oral presentation on Saturday, December 3, 2016 at 2:15 p.m. PT)

Phase 3 ALCANZA Clinical Trial Design

The ALCANZA trial is a randomized, open-label phase 3 study designed to evaluate single-agent ADCETRIS versus a control arm of investigator’s choice of standard therapies, methotrexate or bexarotene, in patients with CD30-expressing CTCL, including those with pcALCL or MF. The primary endpoint is ORR4 as assessed by Global Response Score in the ADCETRIS arm compared to the control arm. Key secondary endpoints are complete response rate, progression-free survival and reduction in the burden of symptoms during treatment. The clinical trial enrolled 131 patients at 50 sites globally. Patients with pcALCL must have received at least one prior systemic or radiation therapy and patients with MF must have received at least one prior systemic therapy. Patients received ADCETRIS every three weeks versus investigator’s choice for up to approximately one year. This international multi-center trial has been conducted in North and South America, Europe and Australia under operational responsibility of Takeda Pharmaceuticals.

ADCETRIS received orphan drug designation from the FDA for the treatment of MF, which is the most common type of CTCL. ADCETRIS also received orphan drug designation from the European Commission for CTCL, including subtypes pcALCL and MF.

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