AstraZeneca breast cancer, asthma and neuromuscular treatments approach approval

27 July 2022 | Eoin Redahan

Three drugs developed by SCI Corporate Partner AstraZeneca could drastically improve breast cancer care, severe asthma treatment, and help those suffering from a rare neuromuscular disease.

AstraZeneca’s (AZ) Enhertu drug for patients with HER2-low metastatic breast cancer has been granted Priority Review in the US.

According to AZ, trial data indicate that Enhertu (trastuzumab deruxtecan) represents the first time a HER-2 targeted therapy has been shown to boost the survival of patients with HER2-low metastatic breast cancer.

David Fredrickson, Executive Vice-President, Oncology Business Unit, AstraZeneca, discusses the potential of Enhurtu in breast cancer treatment.

If approved, Enhertu, which has been developed with Daiichi Sankyo, will treat US patients with unresectable (unable to be removed by surgery) or metastatic HER-2 low breast cancer who have received therapy in a metastatic setting.

The Food and Drug Administration only grants Priority Review to applications for medicines that could offer significant improvements over available treatment options. With more than two million cases of breast cancer diagnosed globally in 2020 alone and nearly 685,000 deaths, there is a pressing need for better therapeutics.

Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca, said: ‘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.’

In further good news, AZ’s Tezspire drug for treating severe asthma has been recommended for approval in the EU. According to AZ, Tezspire (tezepelumab) has been recommended for marketing authorisation as an add-on therapy for patients aged 12 or over who have severe asthma that is inadequately controlled with some existing treatments.

Tezspire was approved in the US for patients aged 12 years and older with severe asthma in December 2021.

In a NAVIGATOR Phase III trial, Tezspire outperformed a placebo taken alongside a standard therapy. Dr. Stephanie Korn, Senior Physician in Pneumology and Respiratory Medicine at IKF Pneumologie Mainz and Thoraxklinik Heidelberg, Germany, and investigator for the NAVIGATOR trial said: ‘Due to the complexity of severe asthma, about 60% of patients have multiple drivers of inflammation.

‘Tezspire is a first-in-class biologic acting at the top of the inflammation cascade and a much-needed potential treatment for patients who continue to struggle with severe, uncontrolled asthma.’

AZ’s Ultomiris drug has also been recommended for approval in the EU to treat adults with generalised myasthenia gravis – a rare, chronic, autoimmune neuromuscular disease that leads to a loss of muscle function and severe weakness.

Following the positive results from the CHAMPION-MG Phase III trial, the company says the drug has both had an early effect and a demonstrable improvement in daily living activities.

Neurologist Dr Thomas Pitts describes how the rare neuromuscular condition myasthenia gravis occurs when the immune system attacks healthy cells.

Professor Renato Mantegazza, CHAMPION-MG trial investigator, said: ‘gMG is a rare and complex disorder that requires early, consistent and reliable intervention.’

Professor Mantegazza, who is based at the Department of Neuroimmunology and Neuromuscular Diseases, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, added: ‘This positive recommendation offers hope to the community for an effective long-acting option that will require fewer treatments each year and help improve disease management.’

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