TLDR
- INCY fell 0.78% to $98.22 as Japan approved Minjuvi for relapsed DLBCL use.
- Japan cleared Minjuvi with lenalidomide for adults with relapsed DLBCL care.
- L-MIND data showed a 58.8% response rate in transplant-ineligible DLBCL cases.
- J-MIND results showed a 71.4% response rate in Japanese DLBCL patients studied.
- Minjuvi now has two Japan approvals across DLBCL and follicular lymphoma use.
Incyte Corporation (INCY) closed lower despite a new Japan approval for Minjuvi in relapsed or refractory DLBCL. INCY ended at $98.22, down 0.78%, after an early move above $100 faded. However, the stock recovered late and held near $99 before the close.
Japan Approval Expands Minjuvi Use
Incyte Biosciences Japan said Japan’s health ministry approved Minjuvi with lenalidomide for adult patients. The approval covers relapsed or refractory diffuse large B-cell lymphoma. The treatment now adds another option for a hard-to-treat lymphoma group in Japan.
DLBCL ranks as the most common subtype of non-Hodgkin lymphoma. The disease affects B lymphocytes and often progresses quickly when treatment fails. Although many patients respond to initial therapy, relapsed cases still create serious medical challenges.
The approval targets patients who cannot receive autologous stem cell transplant. That group often faces limited choices after prior systemic therapies. As a result, Japan’s decision gives Incyte a broader commercial and clinical role in blood cancer care.
Trial Data Supports Regulatory Decision
Incyte based the approval on data from the L-MIND and J-MIND studies. Both trials tested Minjuvi with lenalidomide in relapsed or refractory DLBCL. The studies focused on patients who lacked eligibility for autologous stem cell transplant.
In the L-MIND trial, the overall response rate reached 58.8% by independent review. The complete response rate stood at 41.3%, while partial responses reached 17.5%. Also, the median duration of response remained unreached after at least 44 months of follow-up.
In the J-MIND trial, the response rate reached 71.4% by independent review. Complete responses reached 45.2%, and partial responses accounted for 26.2%. Meanwhile, Incyte reported neutropenia and thrombocytopenia among the main adverse events.
Minjuvi Builds On Japan Follicular Lymphoma Approval
The latest decision marks Minjuvi’s second regulatory approval in Japan. The drug already holds approval with rituximab and lenalidomide for relapsed or refractory follicular lymphoma. Therefore, the DLBCL approval broadens its use across two lymphoma indications in the country.
Minjuvi is a humanized, Fc-modified monoclonal antibody that targets CD19. The antibody helps trigger B-cell death through apoptosis and immune effector mechanisms. Incyte holds global development and commercialization rights for tafasitamab from Xencor.
The drug also has regulatory approvals outside Japan under related treatment settings. In the United States, Monjuvi carries approval for certain relapsed or refractory DLBCL patients. In Europe, Minjuvi holds conditional authorization for eligible adults with relapsed or refractory DLBCL.
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