Janssen’s Imbruvica (ibrutinib) + Rituximab Receives the EC’s Marketing Authorization for Previously Untreated Patients with Chronic Lymphocytic Leukemia

 Janssen’s Imbruvica (ibrutinib) + Rituximab Receives the EC’s Marketing Authorization for Previously Untreated Patients with Chronic Lymphocytic Leukemia

Janssen, Imbruvica, (ibrutinib), Receives, EC, Marketing Authorisation, Approval, Chronic Lymphocytic Leukaemia

Shots:

  • The approval is based on P-III E1912 study assessing Imbruvica + rituximab (IR) followed by ibrutinib until disease progression or unacceptable toxicity, or six cycles of FCR in 529 previously untreated CLL patients aged ≤70 yrs.
  • Results: @median follow-up of 37 mos. IR treated patients lived longer without disease progression with a PFS (88 %), compared to 75 % for FCR treated patients. The study also showed an OS advantage for the IR regimen
  • Ibrutinib (oral, qd) is a first-in-class BTK inhibitor that blocks the BTK protein and helps abnormal B cells movement out of their nourishing environments in the lymph nodes, bone marrow, and other organs. Ibrutinib is approved for CLL, MCL, and WM in Europe and in 99+ countries for at least one indication

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Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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