Why has the FDA recalled a cancer drug but is it still in use in Europe?

In recent days, there have been news about discontinuation of multiple myeloma drug American pharmacies caused a stir in Europe, because on the old continent it is still routinely prescribed to these cancer patients. This is suspicious. If they are recalled in the USA, then why not here? Isn’t it dangerous?

And the truth is, no, it’s not. The drug in question is blendrepand sold by the company Pharmaceutical company GSKreceived a so-called conditional permit two years ago. In other words, given the emergency care of the patients receiving it, it was approved despite the fact that clinical trials had not yet been completed. It was sanctioned by both European Medicines Agency (EMA)as for himUnited States Drug and Drug Administration (FDA). Both gave the green light, subject to a new evaluation after completion of the test. clinical trials.

This moment has already arrived, and the results are not as expected. The drug remains safe and somewhat effective. However, he did not achieve all the milestones he proposed at the time. For this reason, it has already been withdrawn in the USA. In Europe, this new assessment will not take place until 2023. However, patients 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.

Why did the drug receive conditional approval?

Conditional authorization for a drug is given when serious situationbenefits of its administration far outweigh the risks.

In this case, the EMA explained, it has proven effective in patients with multiple myeloma who are not responding to other treatments. nearly 32% of participants in clinical trialsat the time the authorization was given, responded to the drug with a reaction 11 months. In addition, it continued to be observed in hospitals after his permission.

With regard to side effects, it was observed that the most frequent were corneal injurywhich may affect more than 7 out of 10 people, and low platelets in the blood, which can affect more than 3 out of 10 people.

For the most common serious side effects, which can affect up to 1 in 10 people, they were pneumonia, fever and infusion reactions, which is its way of introducing. However, it has also been noted that most of these effects are reversible and correctable with dose changes and careful monitoring. Therefore, the benefits were considered to outweigh the risks, and a drug authorization was chosen.

However, both the EMA and the FDA approved it with two conditions. On the one hand, its use only in patients who have responded inadequately to previous treatment with monoclonal antibodies. And on the other hand, count on the team a physician experienced in dealing with the aforementioned side effects.

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What will happen to these cancer patients now?

Clinical trials of Blenrep have already been completed. In this way, GSK was held accountable to the health authorities who provided them with conditional permission. Side effects have not changed. They are still manageable. However, when it comes to efficiency, there were promises they failed to deliver.

For example, we expected to further increase the response time, older than 11 monthsBut it was impossible. This can be seen as a problem, but it should be noted that other multiple myeloma drugs have a response time of 7 months. Therefore, although the difference is not great, it is relevant enough to draw attention to it.

The FDA is very strict in this regard, so withdrawn approval. As for the EMA, it has not yet done a new review of clinical trials. However, because it is effective in patients who are resistant to other treatments, it is expected to continue to be used.

After all, parole is nothing new or dangerous. While the green light is being given before the end of the clinical trials, this is done with minimal guarantees and in the knowledge that it will result in corresponding benefits. In the case of this drug, the benefits for patients with multiple myeloma are more than obvious. So for those who get it, don’t panic about the US decision. It wasn’t nothing to do with its risks.