FDA approvals announced for advanced RCC, CML
medwireNews: The armamentarium has been extended for US patients with a recent diagnosis of advanced renal cell carcinoma (RCC) or newly diagnosed chronic myeloid leukemia in the chronic phase (CML–CP).
This decision follows an earlier approval for the use of the multikinase inhibitor in patients who have previously received anti-angiogenic therapy for advanced disease.
Bosutinib has been given accelerated approval for first-line use in patients with CML–CP who test positive for the Philadelphia chromosome.
The decision is based on the BFORE trial findings for the second-generation tyrosine kinase inhibitor that were initially presented at the 2017 American Society of Clinical Oncology annual meeting, in Chicago, Illinois, USA.
Newly diagnosed patients given bosutinib were significantly more likely to achieve a major molecular response at 12 months than their imatinib-treated counterparts. The recommended dose is 400 mg/day, to be taken with food.
Bosutinib was previously granted FDA approval for use by patients with CML in the chronic, accelerated or blast phase who have developed resistance or intolerance to prior therapy.
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