GSK receives accelerated approval from US regulator for its lung cancer drug

GlaxoSmithKline has obtained accelerated approval from the US regulator for a lung cancer drug.

The US Food and Drug Administration (FDA) has granted the pharmaceutical giant “breakthrough therapy designation” for the drug, which is being developed with its Chinese partner Hansoh Pharma.

This faster-release status is given to drugs that have the potential to treat serious diseases and when there is early clinical evidence showing they are superior to already available treatments.

The antibody drug, known by the name HS-20093 or code GSK5764227, is for extensive-stage small cell lung cancer.

It is aimed at patients whose condition has progressed or who have received some type of chemotherapy.

Early research trials in China have been promising, according to the London-listed company. Details of the trial will be presented at the 2024 World Conference on Lung Cancer next month.

Hesham Abdullah, Senior Vice President and Global Head of Oncology, Research and Development at GSK, said: ‘Advanced small cell lung cancer is aggressive, has a poor prognosis and a significant need for new treatments.

‘Today’s Breakthrough Therapy Designation supports our ambition to accelerate GSK5764227 for these patients.’

The positive update is a boost for GSK Chief Executive Emma Walmsley, who has been leading a turnaround strategy at the company.

In 2022, it revealed plans to refocus the pharmaceutical giant on vaccines and infectious diseases, including the sale of its consumer healthcare division Haleon.