お知らせ • Mar 18
Knight Therapeutics Inc. Announces Approval of Azzdditional Indication for Minjuvi (Tafasitamab) in Brazil
Knight Therapeutics Inc. announced that its Brazilian affiliate, United Medical Ltda. has received approval from ANVISA, the Brazilian health regulatory agency, for an additional indication for MINJUVI (tafasitamab). The approval follows a supplemental regulatory filing and review by ANVISA under Project Orbis for MINJUVI, in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). The approval is supported by data from clinical studies evaluating MINJUVI in combination with rituximab and lenalidomide (R2), which demonstrated meaningful response rates and durable disease control in patients with previously treated FL. Knight entered into an exclusive supply and distribution agreement with Incyte (NASDAQ: INCY) in 2021 for tafasitamab (commercialized as MONJUVI (tafasitamab-cxix) in the United States and MINJUVI ex-USA) across Latin America. Knight has launched MINJUVI in Brazil, Mexico and Argentina for use in combination with lenalidomide followed by MINJUVI monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLCBL arising from low grade lymphoma in Brazil, who are not eligible for autologous stem cell transplantation (ASCT). MINJUVI (tafasitamab) is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). Incyte licenses exclusive worldwide rights to develop and commercialize tafasitamab from Xencor Inc. In the U.S., MONJUVI is approved by the U.S. FDA in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). MONJUVI is not approved and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials. Additionally, MONJUVI received accelerated approval in the United States in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). In Europe, MINJUVI (tafasitamab) received conditional Marketing Authorization from the European Medicines Agency in combination with lenalidomide, followed by MINJUVI monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT. Additionally, MINJUVI is approved in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) (Grade 1-3a) after at least one line of systemic therapy in Europe. In Japan, MINJUVI is approved in combination with rituximab and lenalidomide for adult patients with relapsed or refractory follicular lymphoma (2L+ FL). In Brazil, MINJUVI is approved for use in combination with lenalidomide followed by MINJUVI monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLCBL arising from low grade lymphoma in Brazil, who are not eligible for autologous stem cell transplantation (ASCT) and is also approved in MINJUVI, in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). MINJUVI is not approved and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials. FL is the most common subtype of indolent non-hodgkin lymphoma (NHL). FL typically presents with generalized painless lymphadenopathy that waxes and wanes. It commonly affects the axillary, cervical, femoral, and inguinal lymph nodes. Rarely, it may appear as an asymptomatic large mediastinal mass. Roughly 20% of FL patients experience B symptoms such as night sweats, fever, and weight loss. Although patients usually respond to initial therapy, FL will typically relapse over time and is therefore considered incurable. Approximately a quarter of FL patients are refractory to first-line immunochemotherapy. Additionally, there is a risk of histologic transformation to DLBCL or high-grade B-cell lymphomas, which occurs at an estimated annual rate of 2% to 3% and is generally associated with a poor clinical outcomes. In Brazil, according to the 2023 data from the INCA Registries, the expected incidence/year of NHL (inclusive of all subtypes) was 5.57 per 100,000 in the general population. It is expected that follicular lymphoma constitutes 20% to 25% of adult NHL cases. Globally it is believed to have an estimated prevalence of 1/3000 thus making it a rare disease by both Global and Brazilian regulatory standards. The inMIND study (INCMOR 0208-301) was a Phase 3, randomized, double-blind, placebo-controlled, multicenter study in participants with relapsed/refractory FL or relapsed/refractory marginal zone lymphoma (MZL) who had been previously treated with at least one prior line of systemic therapy, including an anti-CD20 antibody. Patients were randomized to receive either tafasitamab + R2 (n = 273) versus placebo + R2 (n = 275). The estimated median progression free survival (PFS; primary endpoint) was 22.37 months (95% CI: 19.22, NE) in the tafasitamab + R2 group compared with 13.93 months (95% CI: 11.53, 16.39) in the placebo + R2 group, with a HR of 0.434 (95% CI: 0.324, 0.580) and a p < 0.0001. Overall, adding tafasitamab to lenalidomide plus rituximab led to a statistically significant, clinically meaningful improvement in PFS, corresponding to a 57% lower risk of progression, relapse, or death in patients with relapsed/refractory follicular lymphoma. The most common adverse reactions (= 20%) in patients with relapsed or refractory FL were respiratory tract infections, diarrhea, rash, fatigue, constipation, musculoskeletal pain, and cough. The most common Grade 3 or 4 laboratory abnormalities (= 20%) were decreased neutrophils and decreased lymphocytes.
