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FDA Approves J&J s BTK Inhibitor for Chronic Lymphocytic Leukemia Treatment

April 23, 2020

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The Janssen Pharmaceutical Companies of Johnson & Johnson announced on April 21, 2020 that FDA has approved Imbruvica (ibrutinib), a once-daily Bruton’s tyrosine kinase (BTK) inhibitor, in combination with rituximab for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma who are new to therapy.

According to a company press release, the approval was based off of positive results from a Phase III study that showed patients 70 years or younger treated with the BTK inhibitor lived longer without disease progression, with a progression-free survival rate of 88% over the course of 37 months.

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