AstraZeneca’s Imfinzi, Lynparza recommended for approval in EU by CHMP
The Fly

AstraZeneca’s Imfinzi, Lynparza recommended for approval in EU by CHMP

AstraZeneca’s Imfinzi and Lynparza have been recommended for approval in the European Union, EU, as treatment for certain patients with primary advanced or recurrent endometrial cancer. Imfinzi plus chemotherapy as 1st-line treatment followed by Lynparza and Imfinzi has been recommended for patients with mismatch repair proficient, pMMR, disease. The Committee for Medicinal Products for Human Use, CHMP, of the European Medicines Agency, EMA, based its positive opinion on a prespecified exploratory subgroup analysis by mismatch repair, MMR, status from the DUO-E Phase III trial, which was published in the Journal of Clinical Oncology in October 2023. This analysis showed a reduction in the risk of disease progression or death for pMMR patients in the Lynparza and Imfinzi arm by 43% versus the control arm.1 Results for dMMR patients showed a reduction in the risk of disease progression or death in the Imfinzi arm by 58% versus the control arm.

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