GSK PLC on Tuesday said a targeted antibody-drug conjugate received a breakthrough therapy designation from the US Food & Drug Administration.

The London-based pharmaceutical company said the designation was for GSK227, its B7-H3-targeted antibody-drug conjugate in relapsed or refractory extensive-stage small-cell lung cancer.

It will be evaluated for the treatment of patients with extensive-stage small-cell lung cancer with disease progression on or after platinum-based chemotherapy.

The designation is supported by data from the ongoing Artemis-001 phase 1 trial of more than 200 patients evaluating the safety, tolerability and preliminary anti-tumour activity in locally advanced or metastatic solid tumours such as relapsed or refractory extensive-stage small-cell lung cancer.

‘Extensive-stage small-cell lung cancer is aggressive with poor prognosis and significant need for new treatments. Today’s breakthrough therapy designation supports our ambition to accelerate GSK’227 for these patients as part of our broader ADC programme focused on developing new treatment options with transformational and first-to-market potential,’ said Hesham Abdullah, senior vice president, global head of GSK’s Oncology, research & development unit.

GSK shares were 0.5% lower at 1,590.90 pence each on Tuesday morning in London.

Copyright 2024 Alliance News Ltd. All Rights Reserved.