AbbVie Imbruvica receives FDA approval for 11 indications

Recently, AbbVie announced that the US Food and Drug Administration (FDA) approved the combination of Imbruvica with rituximab for the treatment of chronic lymphocytic leukemia (CLL) / small Patients with lymphocytic leukemia (SLL). This marks the 11 indication approvals that Imbruvica has received since its launch in 2013, and 6 approvals for CLL indications.

 

Brian Koffman, chief medical officer and executive vice president of the CLL Institute, said: “For many CLL patients, intravenous chemotherapy has been the gold standard for clinical first-line treatment for many years, but many patients cannot tolerate chemotherapy. For patients, the FDA approval of Imbruvica + rituximab treatment plan is undoubtedly exciting news. This will also promote the change of clinical treatment for young CLL patients. "

 

The FDA's approval was mainly based on Imbruvica's Phase III E1912 research results. The FDA has accelerated the approval process for this application by using various approaches such as real-time oncology review (RTOR), priority review, and Orbis program. In the E1912 study, 529 untreated CLL patients (under 70 years old, median age 58 years old) were enrolled. They were randomly divided by 2: 1 and received Imbruvica + rituximab (= 354) and fludarabine + Cyclophosphamide + rituximab (FCR, n = 175). The results show that Imbruvica + rituximab can significantly prolong progression-free survival (PFS) compared to FCR regimen.