- Breast cancer drug Enhertu granted US priority review
- EU marketing recommendation for asthma drug Tezspire
- Ultomiris, a treatment for rare autoimmune disease receives EU marketing approval
Pharmaceutical firm AstraZeneca (AZN) said its metastatic breast cancer treatment Enhertu has been granted priority review by the US Food and Drug Administration.
Enhertu is being jointly developed and commercialized in partnership with Daiichi Sankyo. The treatment is already approved as a third line of therapy for patients with later stages of the disease and for a second line therapy for metastatic gastric cancer.
The treatment demonstrated positive results from the pivotal DESTINY-Breast04 Phase III trial which indicated potential for a broader use as a second-line treatment for breast cancer.
The US regulator grants priority review to applications for medicines which if approved would offer ‘significant’ improvements over available options by demonstrating efficacy or safety benefits.
REAL-TIME INITIATIVES
The priority review is part of two new initiatives which are designed to bring safe and effective cancer treatments to patients as early as possible.
They allow the regulator to review components of an application before submission of a complete application.
Executive vice president of cancer at AstraZeneca, Susan Galbraith commented: ‘For more than two decades, only patients with HER2-positive breast cancer have been able to benefit from HER2-targeted therapies.
‘If approved, Enhertu will redefine how we classify and treat metastatic breast cancer, enabling patients whose tumours have lower levels of HER2 expression the opportunity to benefit from a HER2-directed therapy.’
The FDA is expected to give its decision on the review during the fourth quarter of 2022. Regulatory reviews of Enhertu are also being conducted in the EU and Japan.
RECOMMENDATIONS FOR APPROVAL
AstraZeneca also said it had received a recommendation for marketing approval from the Committee for Medicinal Products for Human Use in the EU for its asthma drug Tezspire.
The company said ‘Tezspire consistently and significantly reduced asthma exacerbations across Phase II and III clinical trials, which included a broad population of severe asthma patients irrespective of key biomarkers.’
In addition, AstraZeneca received a recommendation for marketing approval in the EU for Ultomiris, a treatment for adults with generalised myasthenia gravis, a rare autoimmune neuromuscular disease.
Investors welcomed the positive updates with the shares gaining 1% to £108.75 on Monday, taking the year-to-date gains to 25%.
