1st Jul 2024 09:13
(Alliance News) - AstraZeneca PLC on Monday said two cancer treatments had been recommended for approval in the European Union, while there was also positive news for a Covid treatment.
Imfinzi and Lynparza have been recommended for approval by the Committee for Medicinal Products for Human Use of the European Medicines Agency, for certain patients with primary advanced or recurrent endometrial cancer, AstraZeneca said.
Cambridge-based AstraZeneca also said Imfinzi plus chemotherapy as first line treatment followed by Lynparza and Imfinzi has been recommended for patients with mismatch repair proficient disease.
Imfinzi plus chemotherapy followed by Imfinzi alone has been recommended for patients with mismatch repair deficient disease, the pharmaceutical company added.
The CHMP opinion was based on a pre-specified exploratory subgroup analysis by mismatch repair status from the DUO-E phase 3 trial, which was published in the Journal of Clinical Oncology in October 2023.
The analysis showed a reduction in the risk of disease progression or death for pMMR patients in the Lynparza and Imfinzi arm by 43% compared with the control arm.
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."
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.
In addition, AstraZeneca said a marketing authorisation application or MAA for sipavibart has been accepted under an accelerated assessment procedure by the EMA, for the pre-exposure prevention of Covid-19 in immunocompromised patients.
Sipavibart is an investigational long-acting antibody designed to provide Covid-19 protection for immunocompromised patients who often do not respond adequately to vaccination alone and remain at high risk of serious outcomes from Covid-19.
The EMA’s CHMP granted sipavibart accelerated assessment as it was deemed of major interest for public health and therapeutic innovation. Accelerated assessment aims to reduce the timeframe for the CHMP to review a MAA compared to the standard procedure.
The MAA is based on positive results from the Supernova phase 3 trial which demonstrated sipavibart’s safety and efficacy in preventing symptomatic Covid-19 in immunocompromised patients, compared to the control group.
Shares in AstraZeneca eased 0.2% to 12,330.00 pence in London early on Monday.
By Jeremy Cutler, Alliance News reporter
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