EU regulator recommends stopping sale of GSK's blood cancer drug

Illustration shows GSK (GlaxoSmithKline) logo

By Maggie Fick

(Reuters) -The EU drug regulator on Friday recommended against renewing the conditional marketing authorisation for GSK's blood cancer drug Blenrep, which GSK stopped selling in the U.S. last year at the request of the U.S. Food and Drug Administration.

Shares in the British drugmaker were up 1.8% at 1343 GMT. A GSK shareholder told Reuters this was unsurprising given what was already decided in the United States.

But one analyst said that the news was a reminder of GSK's need to bolster its pipeline of drugs in development, having suffered a series of clinical trial setbacks in its cancer drugs portfolio over the past year.

Only a few years ago, GSK had pushed to rebuild its oncology portfolio, in part through deals such as the $5.1 billion purchase in 2019 of U.S. biopharmaceuticals company Tesaro.

Though the EMA’s decision was expected, "This underscores how the company needs something else to bolster its pipeline," said UBS analyst Michael Leuchten.

Last November Blenrep failed to meet the main goal in a late-stage study designed to show it was better than an existing treatment on the market, leading GSK to stop selling it in the United States.

GSK will request a re-examination of the decision based on its belief that the risk-benefit profile for the drug remains favourable, a spokesperson said.

But given that the drug had already been pulled from the U.S. market and Blenrep only accounted for 9 million pounds ($11.18 million) of sales in the second quarter of this year, the EU regulator's decision on Friday was "kind of a non-event", a second analyst told Reuters.

The blood cancer drug made 118 million pounds in sales in 2022, the second-largest contributor to the company's oncology business.

Recommendations made by the human medicines committee will have to be formally approved by the European Commission.


($1 = 0.8053 pounds)

(Reporting by Khushi Mandowara in Bengaluru; Editing by Shounak Dasgupta and Louise Heavens)