WILMINGTON, DE — Japan’s Ministry of Health, Labour and Welfare has approved Minjuvi (tafasitamab) in combination with lenalidomide for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), providing a new treatment option for patients with limited alternatives after initial therapy failure, according to Incyte Biosciences Japan.
The approval expands Minjuvi’s presence in Japan and marks the drug’s second authorization in the country. Minjuvi had previously been approved in combination with rituximab and lenalidomide for adults with relapsed or refractory follicular lymphoma.
DLBCL is the most common form of non-Hodgkin lymphoma and is considered an aggressive blood cancer. Patients whose disease returns or does not respond to treatment often face poor outcomes, particularly if they are not candidates for autologous stem cell transplantation.
The approval was supported by data from two clinical studies evaluating tafasitamab plus lenalidomide in patients with relapsed or refractory DLBCL who were ineligible for autologous stem cell transplant.
In the international Phase II L-MIND trial, the treatment achieved an overall response rate of 58.8%, including a complete response rate of 41.3% and a partial response rate of 17.5%. Researchers reported that median duration of response had not been reached after at least 44 months of follow-up.
In Japan’s Phase Ib/II J-MIND trial, the combination produced a 71.4% response rate, including complete responses in 45.2% of patients and partial responses in 26.2%.
The most commonly reported adverse events included neutropenia and thrombocytopenia, according to the company.
“This approval provides a new option for patients in Japan living with relapsed or refractory DLBCL, an aggressive disease with historically limited treatment options,” said Yasuyuki Ishida, general manager of Incyte Biosciences Japan.
Tafasitamab targets the CD19 protein found on B cells and is designed to trigger immune-mediated destruction of cancerous cells. Incyte holds exclusive worldwide commercialization rights for the therapy under a licensing agreement with Xencor.
The treatment has previously secured regulatory approvals in other major markets. In the United States, Monjuvi, the U.S. brand name for tafasitamab, is approved in combination with lenalidomide for certain adults with relapsed or refractory DLBCL who are not eligible for stem cell transplantation. The therapy is also approved in the United States and Europe for certain patients with relapsed or refractory follicular lymphoma.
The Japanese approval further expands Incyte’s oncology portfolio in Asia and strengthens the company’s position in the treatment of B-cell malignancies.
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