Active ingredient: mogamulizumab-kpkc
Diseases: Mycosis fungoides and Sézary disease
Peak sales estimate: n/a
Approved: August 8
Company: Kyowa Hakko Kirin
The scoop: Sold in Japan since 2012, Poteligeo is the first anti-CCR4 antibody to be made available in the U.S., according to the manufacturer Kyowa Hakko Kirin. It was approved in August for relapsed or resistant mycosis fungoides and Sézary syndrome—the two most common types of cutaneous T-cell lymphoma—after at least one previous therapy. Mycosis fungoides account for about half of all cases, while Sézary disease numbers around 3%, but is more aggressive. They are often mistaken for other common skin conditions.
Kyowa has filed an application in the European Union, but its also testing the drug in early-phase combination trials with its in-house IDO inhibitor, KHK2455, as well as with Bristol-Myers Squibb’s Opdivo and AstraZeneca’s Imfinzi against solid tumors. In 2017, Poteligeo brought in 1.9 billion yen, or about $17 million in sales. Kyowa’s approval came just a few months after its FDA nod this year for Crysvita (burosumab-twza), developed with Ultragenyx, for X-linked hypophosphatemia. — Conor Hale