- AstraZeneca's cancer drug combo gets green light
- Applications being reviewed in several countries
- Covid-19 prevention drug gets fast-tracked
A combination of AstraZeneca’s (AZN) cancer treatments Imfinzi and Lynparza has been recommended for approval in the EU by the CHMP (Committee for Medicinal Products for Human Use) for patients with certain advanced or recurrent endometrial cancer.
In addition, Imfinzi plus chemotherapy followed by Imfinzi alone has been recommended for patients with mismatch repair deficient disease. These patients have an inability to correct DNA replication errors, resulting in increased risk of cancer.
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STRONG EFFICACY
The recommendations follow positive results from the DUO-E phase three trials where both regimes demonstrated ‘statistically significant’ and ‘clinically meaningful’ improvement in progression-free survival compared with chemotherapy alone.
Data from the trials showed improvements of 43% improvement and 58% respectively for the two regimes versus the current standard of care.
Susan Galbraith, vice president of oncology research at AstraZeneca commented: ‘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 late-stage trial.
Endometrial cancer is the fourth most-common cancer in women across Europe with 125,000 diagnoses and more than 30,000 deaths in 2022 according to the World Health Organisation.
Separately, AstraZeneca said its Covid-19 prevention drug Sipavobart has been granted a ‘fast track’ application in the EU, based on positive results from a late-stage trial which showed the drug reduced the risk of infection for immunocompromised patients. The accelerated assessment is intended to speed up the European Medicines Agency’s review in cases deemed of major interest for public health and therapeutic innovation.
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