After a long clinical odyssey, the FDA tapped this PhIII anti-CCR4 as a ‘breakthrough’ lymphoma drug
A day after Kyowa Hakko Kirin and Ultragenyx filed their application to sell burosumab, the Japanese pharma company is following up with the news that it has won the FDA’s breakthrough therapy designation for their late-stage lymphoma drug mogamulizumab.
Approved in Japan over the last few years for several indications, the FDA is enthusiastic about the anti-CCR4’s chances for Mycosis Fungoides and Sézary Syndrome — two types of cutaneous T-cell lymphoma — as a second-line therapy.
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