Europe's health regulator stuck to its recommendation not to renew conditional approval for GSK's blood cancer drug Blenrep on Friday, citing data that did not confirm its effectiveness.
While the recommendation by a European Medicines Agency (EMA) committee has to be formally approved by the European Commission, it represents a setback to a key oncology business which GSK has been looking to strengthen.
The EMA's human medicines committee (CHMP) said the benefits of Blenrep, which was the second-largest contributor to GSK's oncology business in 2022, "no longer outweigh its risks".
GSK's shares closed 2.9% lower at 1,419.2 pence.
The CHMP first recommended against renewing the conditional marketing authorisation (CMA) for the GSK multiple myeloma treatment in September. Multiple myeloma, the second-most common blood cancer in the world, starts in plasma cells in bone marrow and ultimately disrupts the production of normal blood cells.
"We continue to explore potential new treatment options for patients with relapsed/refractory multiple myeloma," a GSK spokesperson said in an emailed statement on Friday.
GSK said last month that Blenrep had reached a key goal in a separate late-stage trial.
Blenrep was pulled from U.S. markets last year after it failed a late-stage study designed to show it was better than an existing treatment available in the market.
The drug belongs to a category of treatments called antibody-drug conjugates, which are engineered antibodies that bind to tumour cells and then release cell-killing chemicals.
https://news.yahoo.com/eu-regulator-reiterates-guidance-stop-142718234.html
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