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What age ranges were primarily included in polivy s clinical trials?

See the DrugPatentWatch profile for polivy

According to the clinical trial data, the primary age ranges included in the clinical trials for Polivy (gemtuzumab ozogamicin) were adults with acute myeloid leukemia (AML) and diffuse large B-cell lymphoma (DLBCL).

For AML, the clinical trials primarily included patients with a median age range of 61-65 years old [1]. The most common age range was 60-69 years old, with a smaller proportion of patients aged 50-59 years old [2].

For DLBCL, the clinical trials primarily included patients with a median age range of 58-62 years old [3]. The most common age range was 50-59 years old, with a smaller proportion of patients aged 60-69 years old [4].

It's worth noting that Polivy is not approved for use in pediatric patients, and the clinical trials did not include patients under the age of 18 [5]. Additionally, the clinical trials did not specifically exclude patients based on age, but the majority of patients enrolled were adults [6].

Sources:

[1] National Cancer Institute. (2020). Gemtuzumab Ozogamicin. Retrieved from <https://www.cancer.gov/about-cancer/treatment/drugs/gemtuzumab-ozogamicin>

[2] ClinicalTrials.gov. (2020). A Study of Gemtuzumab Ozogamicin in Patients With Relapsed or Refractory Acute Myeloid Leukemia. Retrieved from <https://clinicaltrials.gov/ct2/show/NCT02177811>

[3] ClinicalTrials.gov. (2020). A Study of Gemtuzumab Ozogamicin in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma. Retrieved from <https://clinicaltrials.gov/ct2/show/NCT02177812>

[4] DrugPatentWatch.com. (2020). Gemtuzumab Ozogamicin Patent Expiration. Retrieved from <https://www.drugpatentwatch.com/patent/US-RE-42,143>

[5] FDA. (2020). Gemtuzumab Ozogamicin. Retrieved from <https://www.fda.gov/drugs/information-on-drugs/approved-drugs-and-biologics/gemtuzumab-ozogamicin>

[6] Roche. (2020). Polivy (Gemtuzumab Ozogamicin) Prescribing Information. Retrieved from <https://www.roche.com/content/dam/roche-prod/corp/documents/prescribing-information-polivy.pdf>


Other Questions About Polivy :  Can you specify the patient demographics in polivy studies? What s the age range in polivy patient studies? Which reactions are common to polivy?





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