US health agency reapproves GSK blood cancer drug after new trial
FDA gives go-ahead to UK drugmaker’s multiple myeloma treatment Blenrep
GSK’s chief executive said the company has shown its commitment to pioneering treatments after winning US approval for a blood cancer drug that had previously been withdrawn from sale.
The Food and Drug Administration has approved Blenrep despite the regulator’s own advisory committee voting in July against recommending it, finding that the risks outweighed the benefits. About a third of patients taking the drug, which is designed to tackle treatment-resistant multiple myeloma, suffer temporary blurred eye sight as a side effect.
The advisory vote in July sent GSK’s shares down as much as 7 per cent. The FDA then extended its review period until October and GSK’s shares have sharply rebounded since and are 21 per cent higher this year.
Emma Walmsley, GSK’s chief executive who will be replaced by chief commercial officer Luke Miels at the start of next year, said Blenrep, was “one of the most important” medicines and would help the drugmaker meet its target of £40bn in annual revenue by 2031.
Walmsley took GSK back into oncology in 2018, after her predecessor Andrew Witty retreated from the specialism in 2015. The company generated £1bn in oncology sales last year. Blenrep is expected to generate at least £3bn in sales in its peak year.
But GSK’s re-entry into the lucrative market has not been smooth, with Blenrep withdrawn from sale in the US in 2022 after a trial found it was no better than other treatments.
GSK designed another trial, where patients took Blenrep in conjunction with a drug BorDex. This new trial showed a “statistically significant and clinically meaningful” effect.
“I think sometimes when you get knocked down, it’s about the courage to get back up again,” Walmsley told the Financial Times.
She added that the BorDex study found the drug combination can help patients live an average of three years longer than standard treatment. “That is, by any standards, very meaningful,” she said.
Miels said the company had hired experts, many from AstraZeneca and Roche where he has previously worked, to help design the trial.
“The emergence of a really, really deep oncology business over the next ten years can be very, very exciting,” said Miels. “We’re in very early days, step one or two of a very long staircase.”
Now, GSK will have to convince doctors and healthcare systems to use Blenrep, which has already been approved in the UK and the EU.
GSK is gaining a reputation for turning around overlooked treatments, having uncovered several promising therapies through acquisitions and licensing deals.
A new antibiotic for UTIs, licensed by GSK from Spero Therapeutics in 2022, was so effective that a recent trial was stopped early. It had previously been rejected by the US regulator on the basis of earlier trial results.
Another GSK blood cancer drug, Ojjaara was approved in the US in 2023 after positive clinical trials.
The drug previously showed disappointing results in a late-stage phase 3 trial when it was owned by US biotech Gilead. Gilead subsequently sold it to Sierra Oncology for just $3mn, and GSK bought Sierra for $1.9bn in 2022.
GSK believes Ojjaara will sell more than $1bn a year at its peak.
Walmsley said: “Anyone can spend money, the question is, can we pick assets that have a chance of winning in their field and where the returns will be truly competitive?”