Europe’s health regulator stuck to its recommendation not to renew conditional approval for GSK’s blood cancer drug Blenrep last month, citing data that did not confirm its effectiveness.
The recommendation by a European Medicines Agency (EMA) committee – and which still has to be formally approved by the European Commission – said the benefits of Blenrep, which was the second-largest contributor to GSK’s oncology business in 2022, “no longer outweigh its risks”.
The EMA’s human medicines committee (CHMP) had first recommended against renewing the conditional marketing authorisation (CMA) for the GSK multiple myeloma treatment in September, reports Reuters.
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 November, GSK said Blenrep had reached a key goal in a separate late-stage trial.
The drug was pulled from US markets in 2022 after it failed a late-stage study designed to show it was better than an existing treatment available in the market.
It 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.
Reuters article – EU watchdog deals blow to GSK blood cancer drug Blenrep (Open access)
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