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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.
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.
“We commend the ECOG-ACRIN Cancer Research Group and the National Cancer Institute for conducting a robust study that has generated insightful and landmark results in the treatment of CLL,” said Craig Tendler, MD, vice president, Clinical Development and Global Medical Affairs, Oncology, Janssen Research & Development, in the press release. “We are committed to the continued study of [Imbruvica]-based regimens and building upon the efficacy and safety of the most comprehensively studied BTK inhibitor in our efforts to improve the lives of patients facing a blood cancer diagnosis.”
“FCR, a chemoimmunotherapy-based regimen, has been the standard of care for many previously untreated younger patients with CLL. With the introduction of this ibrutinib-rituximab combination, patients now have a more effective, non-chemoimmunotherapy option,” added Brian Koffman, MD, co-founder and chief medical officer and executive vice president, CLL Society, a nonprofit organization focused on CLL patient education, support, and research, in the press release. “In the 14 years since I was first diagnosed with CLL, the treatment landscape has advanced dramatically for the better, with ibrutinib continuing to play a pioneering role in defining what it means to live with this disease.”
Source: Johnson & Johnson