GlaxoSmithKline plc Sponsored ADR (GSK.US) blood cancer drug Blenrep regains FDA approval and will return to the US market.

The US regulatory agency has approved a blood cancer drug for GlaxoSmithKline plc Sponsored ADR (GSK.US), allowing the pharmaceutical company to reintroduce the drug to the world's largest drug market. The drug was withdrawn from the market in 2022 due to concerns about its effectiveness. The US Food and Drug Administration has approved GlaxoSmithKline plc Sponsored ADR's Blenrep for use in combination with two other drugs to treat patients with relapsed or refractory multiple myeloma who have had an inadequate response to initial treatment. This approval comes with a risk mitigation plan aimed at ensuring the correct use of the drug and simplifying coordination between doctors caring for patients on the medication. Investors' expectations of the drug regaining US approval have decreased after concerns were raised by an FDA advisory panel about the dosing of the drug (including whether reducing the dosage can reduce ocular toxicity while maintaining efficacy). This decision increases the sales potential of Blenrep, with industry research estimating that sales could reach as high as $2.6 billion after approval. This is a victory for the British pharmaceutical company, which has struggled to convince investors of the strength of its new drug pipeline. Earlier this year, the UK became the first country to approve the return of Blenrep to the market for use in treating certain patients with multiple myeloma (an incurable blood cancer). The European Medicines Agency has also given the drug the green light and is expected to grant formal approval later this year. GlaxoSmithKline plc Sponsored ADR withdrew Blenrep from the market in 2022 as it was unable to demonstrate superiority over existing therapies at the time. The company then studied combinations of the drug with other medications and began using it in patients at an earlier stage of the disease. Research has found that this regimen can reduce the risk of death by 42% compared to a drug sold by Johnson & Johnson.