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GSK’s Withdrawn Blood Cancer Drug Paves Path Back to Market

Signage at a GlaxoSmithKline facility in Rockville, Maryland, US, on Monday, Aug. 26, 2024. The US Food and Drug Administration has granted Breakthrough Therapy Designation for GSK227, an investigational B7-H3-targeted antibody drug conjugate being evaluated for the treatment of patients with extensive-stage small-cell lung cancer, according to astatement. Photographer: Graeme Sloan/Bloomberg (Graeme Sloan/Bloomberg)

(Bloomberg) -- GSK Plc said its blood cancer drug significantly reduced the risk of death when combined with another treatment, further boosting the prospects of bringing the previously withdrawn medicine back to market. 

Blenrep helped patients whose myeloma has relapsed to live longer when combined with cancer therapy BorDex. The British drugmaker said Thursday the results of the late-stage trial are “potentially transformative” for patients. The data on Blenrep is likely to change how some patients with myeloma are treated, said GSK Chief Commercial Officer Luke Miels. 

GSK’s shares were little changed in London, and are down about 7% this year. 

The results could help convince regulators of the efficacy of the drug, which is part of GSK’s push into cancer treatments but suffered a setback in 2022. 

At the time, the US Food and Drug Administration said it should be withdrawn from the market following a clinical trial failure in myeloma. The European Medicines Agency also recommended that the conditional approval for the drug shouldn’t be renewed. GSK has refiled in the US, Europe and Japan.

Following the withdrawal, GSK “went back to square one,” hiring new staff who had experience in designing these types of studies and understanding the dosing of the drug to better limit vision side-effects, Miels said on a call with journalists.  

Earlier this year, GSK said Blenrep helped slow disease progression when combined with a different cancer treatment called PomDex.

Blenrep has been removed from the drugmaker’s own financial outlook, however GSK sees potential peak annual sales of over £3 billion ($3.8 billion) if the treatment is approved. The results and the safety data will be presented at a December scientific meeting, GSK said.

(Updates with details from press call from second paragraph)

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