FDA accepts Kyowa Hakko Kirin's BLA for lymphoma candidate

28 November 2017

Shares of Japanese drugmaker Kyowa Hakko Kirin (TYO: 4151) moved up more than 2% to 2,086 yen today, after the company announced that the US Food and Drug Administration had agreed to review the company CTCL candidate under priority status.

The FDA has accepted for review the Biologics License Application (BLA) for mogamulizumab to treat Cutaneous T-cell Lymphoma (CTCL) in patients who have received at least one prior systemic therapy, and has granted Priority Review status.

This BLA is supported by the data from the MAVORIC (Mogamulizumab anti-CCR4 Antibody Versus ComparatOR In CTCL) study, the largest global randomized clinical trial of systemic therapy in CTCL.

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