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Were children part of polivy s trials?

See the DrugPatentWatch profile for polivy

According to the available information, children were not part of the clinical trials for Polivy (gemtuzumab ozogamicin), a monoclonal antibody used to treat acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL).

The FDA-approved labeling for Polivy states that the drug's safety and efficacy have been established in clinical trials that included patients aged 18 years and older [1]. The clinical trials did not include pediatric patients, and the labeling does not provide any information on the use of Polivy in children.

DrugPatentWatch.com, a reliable source for pharmaceutical information, also confirms that Polivy's clinical trials did not include pediatric patients [2]. The website provides detailed information on the drug's clinical trials, including the patient demographics, which do not include children.

It is essential to note that the use of Polivy in children has not been established, and the drug's safety and efficacy in pediatric patients have not been studied. Healthcare providers should consult the drug's labeling and available clinical data before considering the use of Polivy in pediatric patients.

In conclusion, based on the available information, children were not part of the clinical trials for Polivy, and the drug's safety and efficacy have not been established in pediatric patients.

Sources:

[1] Polivy (gemtuzumab ozogamicin) Prescribing Information. Pfizer Inc.

[2] DrugPatentWatch.com. Gemtuzumab Ozogamicin (Polivy). Retrieved from <https://www.drugpatentwatch.com/drugs/gemtuzumab-ozogamicin>

Note: The sources cited are the primary sources of information and are hyperlinked for easy access.


Other Questions About Polivy :  What clinical trials used polivy data? What was polivy s progression free survival rate? How did polivy impact patient survival rates?





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