On a roll at FDA, Kyowa Kirin wins nod for Poteligeo, its drug for hard-to-treat lymphoma

FDA
The FDA approved Kyowa Kirin's Poteligeo to treat mycosis fungoides or Sézary syndrome, two rare types of non-Hodgkin lymphoma. (FDA)

Months after an FDA nod for Ultragenyx-partnered blockbuster hopeful Crysvita, Kyowa Kirin has nabbed U.S. approval for Poteligeo to treat two rare types of non-Hodgkin lymphoma.

The drug, also known as mogamulizumab, is the first anti-CCR4 antibody available in the U.S., according to the company. Approved via the FDA’s “breakthrough” and priority review channels, Poteligeo is now cleared to treat relapsed or resistant mycosis fungoides (MF) or Sézary syndrome (SS) after at least one previous therapy. 

MF accounts for about half of cutaneous T-cell lymphoma (CTCL) cases—lymphomas that arise from the skin—while SS accounts for about 3% but is more aggressive. Because CTCL starts with skin lesions, it’s often mistaken for other common skin conditions.

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In a phase 3 study, Poteligeo held off the cancer's advance for 7.6 months at the median, compared to 3.1 months for Merck & Co.’s chemotherapy Zolinza.

RELATED: Ultragenyx nabs blockbuster FDA nod for $200K-per-year Crysvita

Kyowa Kirin has been selling Poteligeo in Japan since 2012 and collected 1.9 billion Japanese yen ($17 million) from the drug in 2017.

To the Japanese company, the U.S. approval is “another important achievement … in leaping forward to become a global specialty pharmaceutical company,” said Mitsuo Satoh Ph.D., the company’s head of R&D, in a statement.

It now plans to launch the injection in the U.S. in the fourth quarter and has filed an application with the European Medicines Agency. The company declined to disclose its price right now. “We intend to price Poteligeo fairly and responsibly,” a company spokesman told FiercePharma.

RELATED: After disappointing 2016, new drug approvals roared back to life in 2017

Kyowa Kirin’s ambition for Poteligeo doesn’t appear to end with CTCL. It is also testing the drug alongside its own IDO inhibitor KHK2455, Bristol-Myers Squibb’s Opdivo and AstraZeneca’s Imfinzi in solid tumors in early-phase trials.

The Poteligeo nod came about three months after Kyowa Kirin and partner Ultragenyx won FDA approval for Crysvita to treat X-linked hypophosphatemia, a hereditary bone disease that affects about 12,000 people in the U.S. It’s the only treatment that targets the underlying cause of the rare disease, the company says, and it's approved for children and adults.

Ultragenyx and Kyowa Kirin immediately launched that drug in the U.S. and Europe. Evercore ISI analyst Steve Breazzano has predicted a slow ramp-up in the U.S., but an eventual build to blockbuster status by 2025. Under a deal the two signed in 2013, the companies share Crysvita profits in the U.S. and Canada.