FDA grants priority review to mogamulizumab for cutaneous T-cell lymphoma

The FDA granted priority review to mogamulizumab for the treatment of patients with cutaneous T-cell lymphoma who underwent at least one prior systemic therapy, according to the agent’s manufacturer.

Mogamulizumab (Kyowa Hakko Kirin Co. Ltd.) is a humanized monoclonal antibody directed against CC chemokine receptor 4 (CCR4). CCR4 often is expressed on leukemic cells of certain hematologic malignancies, including cutaneous T-cell lymphoma.

The FDA based the priority review designation on results from the MAVORIC study, a randomized phase 3 trial that compared mogamulizumab with an active comparator for patients with mycosis fungoides or Sézary syndrome — the most common subtypes of cutaneous T-cell lymphoma — who failed at least one prior systemic therapy.

The trial included 372 patients from the United States, Europe, Japan and Australia.

The FDA is expected to make a decision on the agent’s approval status by June 4, 2018.

“I am delighted that the FDA accepted the biologics license application for mogamulizumab with priority review, and this is another significant achievement for our subsidiary, Kyowa Kirin Pharmaceutical Development,” Mitsuo Satoh, PhD, executive officer and vice president head of the research and development division at Kyowa Hakko Kirin, said in a company-issued press release. “We will keep working with regulatory authorities such as FDA to make it available to patients with cutaneous T-cell lymphoma in the United States as soon as possible.”

Mogamulizumab is approved in Japan for cutaneous T-cell lymphoma and other hematologic malignancies.

As HemOnc Today previously reported, the FDA granted breakthrough therapy designation to the agent for treatment of patients with mycosis fungoides or Sézary syndrome who underwent at least one prior systemic therapy.

The FDA granted priority review to mogamulizumab for the treatment of patients with cutaneous T-cell lymphoma who underwent at least one prior systemic therapy, according to the agent’s manufacturer.

Mogamulizumab (Kyowa Hakko Kirin Co. Ltd.) is a humanized monoclonal antibody directed against CC chemokine receptor 4 (CCR4). CCR4 often is expressed on leukemic cells of certain hematologic malignancies, including cutaneous T-cell lymphoma.

The FDA based the priority review designation on results from the MAVORIC study, a randomized phase 3 trial that compared mogamulizumab with an active comparator for patients with mycosis fungoides or Sézary syndrome — the most common subtypes of cutaneous T-cell lymphoma — who failed at least one prior systemic therapy.

The trial included 372 patients from the United States, Europe, Japan and Australia.

The FDA is expected to make a decision on the agent’s approval status by June 4, 2018.

“I am delighted that the FDA accepted the biologics license application for mogamulizumab with priority review, and this is another significant achievement for our subsidiary, Kyowa Kirin Pharmaceutical Development,” Mitsuo Satoh, PhD, executive officer and vice president head of the research and development division at Kyowa Hakko Kirin, said in a company-issued press release. “We will keep working with regulatory authorities such as FDA to make it available to patients with cutaneous T-cell lymphoma in the United States as soon as possible.”

Mogamulizumab is approved in Japan for cutaneous T-cell lymphoma and other hematologic malignancies.

As HemOnc Today previously reported, the FDA granted breakthrough therapy designation to the agent for treatment of patients with mycosis fungoides or Sézary syndrome who underwent at least one prior systemic therapy.