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European Commission grants conditional approval for Minjuvi for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma. Incyte + MorphoSys AG

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Published:28th Aug 2021
Incyte and MorphoSys AG announced that the European Commission (EC) has granted conditional marketing authorization for Minjuvi (tafasitamab) in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).

The EC decision follows the positive opinion received from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in June 2021 recommending the conditional marketing authorization of Minjuvi.

The conditional approval is based on the results from the L-MIND study evaluating the safety and efficacy of Minjuvi in combination with lenalidomide as a treatment for patients with relapsed or refractory DLBCL who are not eligible for autologous stem cell transplant (ASCT). The results showed best objective response rate (ORR) of 56.8% (primary endpoint), including a complete response (CR) rate of 39.5% and a partial response rate (PR) of 17.3%, as assessed by an independent review committee. The median duration of response (mDOR) was 43.9 months after a minimum follow up of 35 months (secondary endpoint). Minjuvi together with lenalidomide was shown to provide a clinically meaningful response and the side effects were manageable. Warnings and precautions for Minjuvi include infusion-related reactions, myelosuppression, including neutropenia and thrombocytopenia, infections and tumour lysis syndrome.

Condition: Diffuse Large B Cell Lymphoma
Type: drug

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