The U.S. Food and Drug Administration has granted breakthrough therapy designation to Poteligeo (mogamulizumab) as a treatment for mycosis fungoides and sézary syndrome, the most common subtypes of cutaneous T-cell lymphoma, or CTCL.
“We are excited to hear mogamulizumab received such a valuable designation,” Dr. Mitsuo Satoh, vice president of Kyowa Hakko Kirin, said in a press release. “We will keep on making efforts to provide this antibody to patients with these conditions worldwide.”
The breakthrough therapy designation is aimed at expediting Poteligeo’s continuing development and regulatory review as a CTCL treatment. Kyowa is also meeting with regulatory officials in other countries to discuss marketing authorization application plans for Poteligeo there. In March 2012, Japan’s Ministry of Health, Labor and Welfare approved Poteligeo as a treatment for relapsed or refractory CCR4-positive adult T-cell leukemia-lymphoma.
Poteligeo targets the protein CCR4, which is found at high levels in leukemia and certain lymphoma subtypes, such as CTCL.
Kyowa used it proprietary development platform, Potelligent, to create the antibody. Potelligent revs up an immune mechanism known as antibody-dependent cellular cytotoxicity.
When it binds to CCR4, Poteligeo recruits and activates immune cells to mount an attack on the cancer cells containing the protein.
The FDA designation was based on preliminary data from the ongoing Phase 3 MAVORIC trial (NCT01728805). It is assessing the safety and effectiveness of injected Poteligeo in patients with relapsed or refractory CTCL.
MAVORIC involves 372 patients at 73 research centers in Japan, North America, Europe and Australia.
Researchers divided the patients into two groups. One is receiving Poteligeo until their disease progresses or they begin experiencing unacceptable toxicity. The dose is once a week in the first four weeks, and every other week after that. The other group is receiving Zolinza (vorinostat) once a day, also until disease progression or toxicity.
Those in the Zolinza group can cross over to Poteligeo if their disease progresses.
The study’s primary goal is to see whether Poteligeo does a better job than Zolina in increasing the time for a patient’s disease to progress, or for them to die. Secondary measures include how many patients achieve a complete or partial response to treatment, how Poteoligeo affects patients’ quality of life, and how it affects their pruritus symptoms, or itching.