AstraZeneca drug granted FDA Priority Review

pharmafile | April 19, 2022 | News story | Manufacturing and Production  

AstraZeneca and Daiichi Sankyo have announced that the lung cancer antibody drug conjugate, Enhertu, has received Priority Review from the FDA. Enhertu has showed a 54.9% tumour response rate in trial settings.

The drug has been granted Priority Review for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC), whose tumours have a HER2 (ERBB2) mutation, and who have received a prior systemic therapy.

The Priority Review application process is designed to review medicines that, if approved, would offer significant improvements over available options by demonstrating safety and efficacy improvements, preventing serious conditions, and enhancing patient compliance.

AstraZeneca has shared that the FDA’s decision was based on pivotal DESTINY-Lung01 results, a Phase II trial in which previously-treated patients with HER2-mutations, treated with Enhertu, demonstrated an objective response rate of nearly 55%.

A confirmed disease control rate (DCR) of 92.3% was seen with a reduction in tumour size observed in most patients.

Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo, said: “The results of DESTINY-Lung01 showed that Enhertu is the first HER2-directed therapy to demonstrate a strong and robust tumour response in more than half of patients with previously treated HER2-mutant metastatic non-small cell lung cancer. Seeking approval in the US for a third tumour type in three years further demonstrates the significant potential of Enhertu in treating multiple HER2-targetable cancers.”

Enhertu is being further assessed in a comprehensive clinical development programme evaluating efficacy and safety across multiple HER2-taregtable cancers, including breast, gastric, lung, and colorectal cancers.

Susan Galbraith, AstraZeneca’s executive vice president of oncology R&D, said: “The DESTINY-Lung01 trial confirmed the HER2 mutation as an actionable biomarker in non-small cell lung cancer. If approved, Enhertu has the potential to become a new standard treatment in this patient population, offering a much-needed option for patients with HER2-mutant metastatic non-small cell lung cancer who currently have no targeted treatment options.”

 Ana Ovey

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