AstraZeneca PLC (LSE:AZN) said its drug Enhertu has been granted a priority review by US regulators following the release of data underlining its potential in a group of lung cancer patients that currently have no targeted treatment options.
Its Destiny-Lung01 trial showed a 54.9% response in people with HER2-mutant metastatic 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,” said Susan Galbraith, AstraZeneca's head of oncology research and development.
The US Food & Drug Administration’s priority review process cuts the timeline to approval from 10 months to around six months and is granted to only those treatments that show significant promise.
Enhertu was created using technology developed by the Japanese pharma giant Daiichi Sankyo.
The FDA cleared it for use in HER-2 positive breast cancer and a form of stomach cancer.
It is one of a new generation of treatments called antibody-drug conjugates, which means it carries a very targeted drug payload.
Peak sales are currently set at around US$2.5bn (£1.9bn) a year, although this could rapidly shift towards the upper end of the analysts' forecasts, which is US$4bn, with this latest potential indication for Enhertu.