FDA

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.

Mitsuo Satoh

According to the company, the FDA’s breakthrough designation — a title that has helped to revolutionize the timelines around cancer drug development — was granted based on data from the Phase III MAVORIC study, which recruited 372 patients. We haven’t seen the hard data yet, but in April Kyowa Hakko Kirin heralded a top-line success for progression free survival.

This drug has been around the clinic for years.

Amgen in-licensed the non-oncology indications back in 2008 for $100 million up front and $420 million in milestones — then tossed it back in 2014. The same year Pfizer agreed to do a combo study using the drug with utomilumab (PF-05082566).  And two years ago Bristol-Myers agreed on a Phase I/II combo study with Opdivo.

“We are excited to hear mogamulizumab received such a valuable designation,” said Kyowa Hakko’s R&D chief Mitsuo Satoh.”We will keep on making effort to provide this antibody to patients with these conditions worldwide.”



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