FDA Grants Breakthrough Therapy Designation to Adcetris for Certain Lymphoma Subtypes

FDA Grants Breakthrough Therapy Designation to Adcetris for Certain Lymphoma Subtypes

The U.S. Food and Administration (FDA) has granted Breakthrough Therapy Designation to Seattle Genetics’ Adcetris (brentuximab vedotin) as a therapy for the most common subtypes of cutaneous T-cell lymphoma (CTCL), the CD30-expressing mycosis fungoides (MF) and primary cutaneous anaplastic large cell lymphoma (pcALCL).

This FDA’s designation aims to accelerate the development of drug therapies that have shown to provide better results compared to existing therapies in the treatment of life-threatening diseases. In the case of Adcetris, the designation was supported by promising results obtained in the Phase 3 ALCANZA trial (NCT01578499), which will be presented at this year’s American Society of Hematology (ASH) annual meeting, Dec. 3-6, in San Diego, Calif.

The abstract of the ALCANZA trial, which was accepted for oral presentation is: “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”.

“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,” Clay Siegall, PhD, president and CEO of Seattle Genetics, said in a press release. “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,” Siegall said.

Adcetris is an antibody-drug conjugate targeting CD30, a protein that is expressed on skin lesions in about 50%of patients with CTCL, including those with pcALCL or MF.

The randomized, open-label, international and multi-center ALCANZA study was designed to assess the safety and efficacy of Adcetris versus standard therapies of investigator’s choice, methotrexate or bexarotene, in 131 patients with CD30-expressing pcALCL or MF. Patients with pcALCL had received at least one prior systemic or radiation therapy, whereas those with MF had received at least one prior systemic therapy. Treatment with Adcetris every three weeks versus investigator’s choice was administered for up to one year.

Adcetris significantly improved the objective response lasting at least four months compared to investigator’s choice standard therapies, meeting the study’s primary endpoint. Secondary endpoints included complete response rate, progression-free survival, and reduction in the burden of symptoms during treatment, and also were significantly improved in the Adcetris group.

Adcetris also has been designated orphan drug by the FDA for the treatment of MF, and by the European Commission for the treatment of CTCL, including the subtypes pcALCL and MF.

To date, Adcetris is approved only by the FDA to treat Hodgkin lymphoma in patients whose disease has progressed after autologous stem cell transplant or, for those who cannot undergo a transplant, after two prior chemotherapy treatments. It also is approved to treat patients with systemic ALCL, in whom a prior chemotherapy regimen has failed.

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