Knight Therapeutics Expands MINJUVI® Indication in Brazil for Relapsed/Refractory Follicular Lymphoma
Event summary
- Knight Therapeutics' Brazilian affiliate, United Medical Ltda., received ANVISA approval for MINJUVI® (tafasitamab) in combination with rituximab and lenalidomide for relapsed/refractory follicular lymphoma (FL).
- The approval follows a supplemental regulatory filing under Project Orbis, supported by clinical data showing meaningful response rates and durable disease control.
- MINJUVI® is already approved in Brazil for diffuse large B-cell lymphoma (DLBCL) and has been launched in Brazil, Mexico, and Argentina under a 2021 supply and distribution agreement with Incyte.
- Follicular lymphoma is the most common subtype of indolent non-Hodgkin lymphoma, with an estimated prevalence of 1/3000 globally.
The big picture
This approval strengthens Knight Therapeutics' position in Latin America's oncology market, particularly in Brazil, where follicular lymphoma represents a significant unmet need. The expansion of MINJUVI®'s indication aligns with broader industry trends toward targeted, chemotherapy-free treatments for relapsed/refractory lymphomas. Knight's ability to leverage Project Orbis for faster regulatory reviews could set a precedent for other biopharmaceutical players in the region.
What we're watching
- Regulatory Strategy
- The pace at which Knight Therapeutics can secure additional approvals for MINJUVI® in other Latin American markets under Project Orbis.
- Commercial Execution
- Whether Knight can effectively expand the use of MINJUVI® beyond DLBCL into follicular lymphoma, a larger patient population.
- Partnership Dynamics
- How the collaboration with Incyte evolves as Knight seeks to maximize MINJUVI®'s reach in Latin America.
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