OFF-LABLEL "The FDA does not have the legal autho
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"The FDA does not have the legal authority to regulate the practice of the medicine, and the physician may prescribe a drug off-label. Contrary to popular notion, it is legal in the United States and in many other countries to use drugs off-label, including controlled substances such as opiates."
As soon as Leronlimab approves there is a possibility of using off-label.
In the US 40% of cancer drugs are used off-label.
It is important that the drug is approved, that there are no side effects, and that in the first test the drug showed its efficacy.
This can not be advertised but no one can stop using it, Leronlimab can quickly become very popular.
If Leronlimab at mTNBC shows high efficacy, and is approved as a combo for HIV, I think he will start massively using the off-label, for cancers, even for HIV as mono.