FDA granted Breakthrough Therapy Designation to brentuximab vedotin (Adcetris, Seattle Genetics) to treat patients with the most common subtypes of lymphoma.
FDA granted breakthrough therapy designation to brentuximab vedotin (Adcetris, Seattle Genetics) to treat patients with the most common subtypes of lymphoma.
FDA’s breakthrough therapy designation is intended to expedite the development and review of promising drug candidates for serious or life-threatening conditions.
Adcetris treats 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% of the disease, according to Seattle Genetics.
Adcetris is an antibody-drug conjugate (ADC) directed to CD30 which is expressed on skin lesions in approximately 50% of patients with CTCL.
While Adcetris is currently not approved for the treatment of CTCL, Seattle Genetics plans to submit a supplemental Biologics License Application to FDA in the first half of 2017 for approval. “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, PhD, president and CEO of Seattle Genetics.
The breakthrough therapy designation was based on data from the phase 3 Alcanza clinical trial, which 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 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.
Positive topline results of Adcetris clinical 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, Calif.