In recent days, the news of the withdrawal of a drug against multiple myeloma of American pharmacies has caused a stir in Europe, since in the old continent it is still administered normally to these cancer patients. This breeds suspicion. If they withdraw it in the United States, why not here? Isn’t it dangerous?
And the truth is that no, it is not. The drug in question, called blenrepand marketed by the GSK pharmaceutical company, received what is known as conditional authorization two years ago. In other words, given the emergency of the patients who receive it, it was authorized despite the fact that the clinical trials had not finished. It was authorized by both the European Medicines Agency (EMA)as for hima United States Drug and Drug Administration (FDA). Both gave the green light on the condition of making a new evaluation once the tests were finished. clinical trials.
That moment has already arrived and the results are not as expected. The drug remains safe and somewhat effective. However, it has not reached all the milestones that it proposed at the time. For this reason, in the United States it has already been withdrawn. In Europe, this new evaluation will not be carried out until 2023. However, patients who are receiving it have nothing to fear. It’s still not dangerous, and even if it doesn’t do everything it promises, it’s still better than other multiple myeloma drugs.
The conditional authorization of a drug is given when, in a serious situationthe benefits of its administration significantly outweigh the risks.
In this case, as explained by the EMA, has been shown to be effective in patients with multiple myeloma who do not respond to other treatments. almost a 32% of participants in clinical trialsat the time the authorization was given, responded to the drug, with a response of 11 months. In addition, this has continued to be observed in hospitals after its authorization.
Regarding adverse effects, it was seen that the most common were corneal damagewhich may affect more than 7 in 10 people, and the low platelet count in the blood, which can occur in more than 3 out of 10 people.
As for the most common serious side effects, which may affect up to 1 in 10 people, they were pneumonia, fever and infusion-related reactions, which is its route of administration. However, it was also noted that most of these effects are reversible and manageable with dose modifications and close monitoring. Therefore, it was considered that the benefits outweigh the risks and the authorization of the drug was opted for.
Even so, both the EMA and the FDA they approved it with two conditions. On the one hand, using it only in patients who had not reacted adequately to a previous treatment with monoclonal antibodies. And, on the other, count on the team physician with expertise in the above-mentioned side effects.
What will happen now with these cancer patients?
The clinical trials of Blenrep have already finished. Therefore, GSK has been held accountable to the health authorities who gave them conditional authorization. Adverse effects have not changed. They are still manageable. However, when it comes to efficacy, there have been promises that they have not been able to keep.
For example, they hoped to increase the response time even more, above 11 months, But it has not been possible. It can be seen as a problem, but it should be noted that in other drugs against multiple myeloma this response is 7 months. Therefore, although the difference is not great, it is relevant enough to pay attention to it.
The FDA is very strict in this regard, hence the withdrawn approval. As for the EMA, it has not yet done a new review of clinical trials. However, since it is being effective in patients who have shown resistance to other treatments, it is expected that it will continue to be used.
After all, parole is not something new or dangerous. Although the green light is given before the end of the clinical trials, it is done with minimal guarantees and taking into account that it will entail a significant benefit. In the case of this drug, the benefit is more than clear for patients with multiple myeloma. So, for those who are receiving it, don’t panic about the US decision. This has not had nothing to do with its risks.