US orders withdrawal of new cancer treatment recently approved in Spain

An innovative new cancer treatment that had just been incorporated into Spain’s health system has been hastily withdrawn by the United States after a failed clinical trial. 

The US Food and Drug Administration (FDA) have ordered British pharmaceutical company GlaxoSmithKline (GLK) to halt sales of new cancer therapy Blenrep, following the failure of a recent clinical trial. 

The US ban on the drug comes just two months after its approval in Spain for patients who suffer relapses after receiving all available treatments for multiple myeloma. 

As reported in the Spanish newspaper El País, the FDA approved Blenrep in the summer of 2020 – shortly after its approval by the European Medicines Agency (EMA) – through the shorter and less expensive ‘accelerated’ route.

Blenrep is designed to treat multiple myeloma; a rare cancer of the bone marrow estimated to affect around five in 100,000.

El País reports that a total of 3,200 Spaniards were diagnosed with the hematological cancer in 2020, with the average age of those diagnosed ranging between 65 and 70. 

Though the disease has no known cure, certain treatments are thought to slow its progress. 

But GSK’s Blenrep failed to demonstrate the clinical benefits it was previously thought to possess in recent trials, leading to its withdrawal from the US market. 

The FDA’s withdrawal of the treatment is not to say that there aren’t clinical benefits to Blenrep; but merely that they no longer deem it worthy of its preferential fast-tracked status. 

The ESM, however, is yet to withdraw its fast-tracked approval of the treatment, instead saying it will review and reevaluate the drug at the beginning of next year.

Blenrep will now undergo further clinical trials – considered especially important given the heavily reported adverse side effects of the treatment. 

Nearly three quarters (71%) of patients who receive Blenrep develop problems with their vision, whilst 38 per cent develop a drop in platelets produced in the bone marrow, according to the Therapeutic Positioning Report (IPT) prepared by the Ministry of Health.

María Victoria Mateos, president of the Spanish Society of Hematology and Hemotherapy (SEHH), told El País she is confident Blenrep will still be sold across Europe after the EMA’s reevaluation in the new year.

She said: “It is true that Blenrep has failed to meet the primary endpoint of the trial, but this does not mean that it does not have some clinical benefits. 

“The drug has a novel mechanism of action… and this may make it useful for multiple myeloma patients who have already exhausted this and other treatments to improve their disease-free survival.”

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