(RTTNews) – British drug major AstraZeneca Plc (AZN.L, AZN) announced Monday that Imfinzi (durvalumab) and Lynparza (olaparib) have been recommended for approval in the European Union or EU as treatment for certain patients with primary advanced or recurrent endometrial cancer.
The positive opinion by the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency is based on a prespecified exploratory subgroup analysis by mismatch repair or MMR status from the DUO-E Phase III trial, which showed both regimens demonstrated statistically significant and clinically meaningful improvement in progression-free survival vs. chemotherapy alone.
The company noted that Imfinzi plus chemotherapy as 1st-line treatment followed by Lynparza and Imfinzi has been recommended for patients with mismatch repair proficient or pMMR disease. Further, Imfinzi plus chemotherapy followed by Imfinzi alone has been recommended for patients with mismatch repair deficient or dMMR disease.
The DUO-E Phase III trial results were published in the Journal of Clinical Oncology in October 2023.
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said, “Today’s recommendation for approval in the EU recognises the potential of the Lynparza and Imfinzi combination to provide clinical benefit for patients with endometrial cancer, especially for those with mismatch repair proficient disease who have few available treatments today. If approved, patients in Europe will have a new option for combination treatment that brings the additional benefit of PARP inhibition to immunotherapy.”
AstraZeneca noted that regulatory submissions for Imfinzi and Lynparza are currently under review in Japan and several other countries based on the DUO-E trial.
Imfinzi plus chemotherapy was recently approved for dMMR patients with primary advanced or recurrent endometrial cancer in the US.
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