http://www.raredr.com/news/mogamulizumab-bla-accepted
Mogamulizumab's BLA Accepted for Filing and Priority Review Designation

Mathew Shanley

Based on data from the MAVORIC (Mogamulizumab anti-CCR4 Antibody Versus ComparatOR In CTCL) study, the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for mogamulizumab to treat 2 types of Cutaneous T-cell Lymphoma (CTCL) in patients who have received at least one prior systemic therapy.

Additionally, it was announced that the drug was granted Priority Review status because of its potential to offer a major advancement to the patient population where no adequate treatment currently exists. The Prescription Drug User Free Act (PDUFA) action date for the BLA is June 4, 2018.

In August, Breakthrough Therapy Designation status was granted to Kyowa Hakko Kirin Co, Ltd. for the treatment of Mycosis Fungoides (MF) and Sezary Syndrome (SS) patients.

CTCL is a rare type of non-Hodgkin’s T-cell lymphoma, but the most common type of cutaneous lymphoma. The most frequently occurring types of CTCL are MF and SS. The condition often presents in red, scaly patches or thickened plaques of skin that resemble eczema or dermatitis and, depending on the stage, may also involve the lymph nodes and viscera. Of the two conditions, MF progresses gradually and develops internally over time, while SS is much more aggressive. The latter is characterized by a widespread red rash that could eventually cover most of the body.

Symptoms of both MF and SS include itchiness and the potential for tumors.

Mogamulizumab is a humanized monoclonal antibody (mAb) that targets CC chemokine receptor 4 (CCR4), which is frequently expressed on leukemic cells of specific hematologic malignancies, including CTCL.

“I am delighted that the FDA accepted the BLA for mogamulizumab with Priority Review and this is another significant achievement for our subsidiary, Kyowa Kirin Pharmaceutical Development,” said Mitsuo Satoh, Ph.D., Executive Officer, Vice President Head of R&D Division of Kyowa Hakko Kirin in a press release. “We will keep working with Regulatory Authorities such as FDA to make it available to patients with CTCL in the US as soon as possible.”

The MAVORIC study is a Phase 3 that was conducted in several centers in the U.S., Europe, Japan, and Australia. It enrolled and randomized 372 patients with MF and SS who have failed one or more prior systemic treatments and compared mogamulizumab to active comparator in those patients. The company reported in April that top-line results showed a statistically significant improvement in progression-free survival in the mogamulizumab-treated group when compared to the vorinostat-treated group.

Per an August press release, the company has already initiated discussions with other regulatory authorities in an effort to develop plans for marketing authorization applications for mogamulizumab for the treatment of CTCL in several countries.

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