The British pharmaceutical company GlaxoSmithKline (GSK) has been forced to withdraw one of its innovative cancer therapies from the United States after the failure of a clinical trial of Blenrep, indicated against multiple myeloma. This drug was approved in 2020 through the so-called accelerated route —shorter and less expensive— and now it has not been able to demonstrate the expected efficacy results. This has motivated the US drug agency, the FDA, to have required the company to stop selling the treatment in the country.
The European Medicines Agency (EMA), which also approved the drug two years ago, states in a written response to this newspaper that it "is aware" of the trial results and the measures taken by the FDA and that "the [ new] data will be evaluated to determine if a decision is necessary in the EU”. This review will be done "at the beginning of 2023", when the agency already planned to start the process of "annual renewal of the marketing authorization" of Blenrep.
The FDA measure comes less than two months after the Interministerial Commission on Drug Prices (CIPM), headed by the Ministry of Health, approved on September 29 the incorporation of Blenrep in Spanish public health for patients who have relapsed after receiving all available treatments for multiple myeloma.
Not all drugs approved by the EMA are necessarily introduced into public health. The decision to finance or not a treatment is made based on the available evidence on its efficacy and safety, the needs of hospitals and the price conditions offered by pharmaceutical companies.
Multiple myeloma is the second most frequent type of hematological cancer, with an estimated incidence of about five cases per 100,000 inhabitants. In Spain, a total of 3,200 patients were diagnosed in 2020, with an average age of between 65 and 70 years. It is a disease that has no cure, although the available treatments can slow its progress for a few months or years.
The FDA and the EMA approved Blenrep, whose active ingredient is the monoclonal antibody belantamab mafodotin, a few days apart in the summer of 2020. The former did so by the so-called accelerated route on August 5, a step that the latter had taken conditionally on July 24.
“Each agency has its system, but what is substantial in both cases is that a drug is approved faster than conventional procedures provide because it is considered to have significant potential benefits. This means that even if there are uncertainties about its effectiveness, it is considered worth taking the risk. In return, pharmaceutical companies must carry out new trials to confirm the possible benefits, something that Blenrep has not achieved now”, explains Eduardo López Briz, coordinator of the Genesis group for drug evaluation of the Spanish Society of Hospital Pharmacy (SEFH).
The procedures of the two agencies are similar, but have some differences at the end. The two approve the drug on the fast track when clinical trials are still in the so-called phase II, which provides for shorter tests and with fewer patients, so they are also significantly cheaper to perform. After approval, pharmaceutical companies must carry out —also in the US and Europe— confirmatory trials with more patients, the so-called phase III trials.
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