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Bosulif Approved to Treat Newly-Diagnosed Ph+ CML

Avillion news release; 2017 Dec 19

The US Food and Drug Administration (FDA) has approved Bosulif (bosutinib) to treat adults with newly-diagnosed chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML).

Indications: Bosulif is a kinase inhibitor indicated for the treatment of adult patients with newly-diagnosed chronic phase Ph+ CML.

Dosage and administration: 400 mg orally once daily with food.

Efficacy and safety: Approval is based on results of an open-label phase 3 study that showed Bosulif 400 mg was linked with a significantly higher rate of patients achieving major molecular response at 12 months vs the rate achieved with imatinib 400 mg (47% vs 37%). Complete cytogenic response was 77% and 66%, respectively.

Side effects/risks: The most common adverse reactions are diarrhea, nausea, thrombocytopenia, rash, increased alanine aminotransferase, abdominal pain, and increased aspartate aminotransferase.

Citation:

Avillion announces US Approval of Pfizer's Bosulif (bosutinib) for the treatment of patients with newly-diagnosed Ph+ chronic myelogenous leukemia (CML) [news release]. London: Avillion LLP. December 19, 2017. https://www.prnewswire.com/news-releases/avillion-announces-us-approval-... Accessed December 25, 2017.

Bosulif [package insert]. New York, NY: Pfizer Labs, 2017. http://labeling.pfizer.com/ShowLabeling.aspx?id=884. Accessed December 25, 2017.