U.S. FDA Approves IMBRUVICA ® (ibrutinib) Plus Rituximab for the Treatment of Patients with Chronic Lymphocytic Leukemia (CLL)

HORSHAM, Pa., April 21, 2020 – The Janssen Pharmaceutical Companies of Johnson &Johnson announced today the U.S. Food and Drug Administration (FDA) approval of IMBRUVICA® (ibrutinib) in combination with rituximab for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who are new to therapy. The approval is based on positive results from the landmark Phase 3 E1912 study that was designed and conducted by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) and sponsored by the National Cancer Institute, part of the National Institutes of Health. Today’s milestone marks the 11th U.S. FDA approval for IMBRUVICA® across six disease areas and is the sixth approval for IMBRUVICA® in CLL.The E1912 study showed newly diagnosed patients ages 70 years or younger (median age of 58 years) treated with IMBRUVICA® plus rituximab lived longer without disease progression, with a progression-free survival (PFS) rate of 88 percent at 37 months, compared to patients treated with fludarabine, cyclophosphamide and rituximab (FCR), with a PFS rate of 75 percent. Extended follow-up results from the E1912 study were most recently presented at the 2019 American Society of Hematology (ASH) Annual Meeting. “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 mor...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news

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Source: Expert Review of Hematology - Category: Hematology Tags: Expert Rev Hematol Source Type: research
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