The agency granted priority review to Kyowa Hakko Kirin‘s biologics license application (BLA), which reduces the review time from 10 to six months. A final regulatory decision is expected by June 4, 2018.
A similar application requesting the approval of mogamulizumab for CTCL in the European Union was submitted to the European Medicines Agency last month.
“I am delighted that the FDA accepted the BLA for mogamulizumab with Priority Review and this is another significant achievement for our subsidiary, Kyowa Kirin Pharmaceutical Development,” Mitsuo Satoh, PhD, executive officer and vice president of R&D at Kyowa Hakko Kirin, said in a press release. “We will keep working with Regulatory Authorities such as FDA to make it available to patients with CTCL in the U.S. as soon as possible.”
Mogamulizumab is a humanized antibody that targets CCR4, a protein commonly found on malignant blood cancer cells, including CTCL.
The applications follow the ongoing MAVORIC Phase 3 study (NCT01728805), which is testing if mogamulizumab is better than Zolinza (vorinostat) at keeping cancer at bay.
Zolinza, developed by Merck, is a histone deacetylase (HDAC) inhibitor approved to treat CTCL patients who have progressive, persistent, or recurrent disease following two systemic therapies.
The trial included 372 patients with mycosis fungoides or Sézary syndrome, two CTCL subtypes, from 73 clinical centers across the U.S., Europe, Japan, and Australia.
Compared to Zolinza, mogamulizumab significantly delayed disease progression. An independent review showed that patients on mogamulizumab had progression-free survival of 6.7 months, compared to 3.8 months for those receiving Zolinza.
Mogamulizumab treatment also led to better response rates and improved quality of life, with better functional status and fewer disease symptoms.
The findings will be presented at the upcoming 2017 ASH Annual Meeting in Atlanta. The study is titled, “Anti-CCR4 Monoclonal Antibody, Mogamulizumab, Demonstrates Significant Improvement in PFS Compared to Vorinostat in Patients with Previously Treated Cutaneous T-Cell Lymphoma (CTCL): Results from the Phase III MAVORIC Study“.
Mogamulizumab, sold as Poteligeo, is already approved in Japan for the treatment of CTCL. It also is approved in Japan to treat patients with relapsed or refractory CCR4-positive adult T-cell leukemia-lymphoma and peripheral T-cell lymphoma.
In August 2017, the FDA granted breakthrough therapy designation to mogamulizumab for the treatment of the two most common forms of CTCL, mycosis fungoides and Sézary syndrome.