Knight Therapeutics (KHTRF) announced today that its Brazilian affiliate, United Medical has received approval from ANVISA, the Brazilian health regulatory agency, for an additional indication for MINJUVI. 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. The approval is supported by data from clinical studies evaluating MINJUVI in combination with rituximab and lenalidomide, which demonstrated meaningful response rates and durable disease control in patients with previously treated FL.
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