FDA Approves Rituxan for Previously Untreated and Treated CLL

Strategic Insights -

The U.S. Food and Drug Administration (FDA) has approved Rituxan (rituximab) in combination with fludarabine and cyclophosphamide (FC) for people with previously untreated and previously treated CD20-positive chronic lymphocytic leukemia (CLL). CLL is a slow-growing cancer that affects nearly 90,000 people in the United States, accounting for one-third of all leukemia cases. The approval is based on data from two Phase III studies, CLL8 and REACH, which demonstrated that Rituxan plus FC significantly extends the time people with CLL live without the disease worsening.

Key Takeaways:

  • The FDA approval is based on data from two Phase III studies, CLL8 and REACH, which enrolled 817 and 552 patients, respectively.
  • The primary endpoint for both studies was progression-free survival (PFS), and Rituxan plus FC significantly improved PFS in both previously untreated and previously treated patients.
  • In CLL8, patients who received Rituxan plus FC lived a median of 39.8 months without the disease worsening, compared to 31.5 months for those who received FC alone.
  • In REACH, patients who received Rituxan plus FC lived a median of 26.7 months without the disease worsening, compared to 21.7 months for those who received FC alone.
  • The most common severe (Grade 3 or greater) adverse events in patients who received Rituxan plus FC included cytopenias, infusion-related reactions, and in previously untreated patients, hypotension and hepatitis B.
  • Rituxan works by binding to a specific protein called CD20 found on the surface of cancerous and normal B-cells, and can eliminate marked CD20-positive B-cells with the body's own immune system.
  • The approval reinforces the significance of Rituxan in hematologic cancers, which has now achieved five approvals for the most common forms of non-Hodgkin's lymphoma and adult leukemia.
  • Approximately 15,000 new CLL cases are expected to be diagnosed in the U.S. in 2009.

Statistics:

  • 87,910 people in the United States are living with CLL, accounting for one-third of all leukemia cases (American Cancer Society).
  • 15,000 new CLL cases are expected to be diagnosed in the U.S. in 2009.
  • 817 patients were enrolled in CLL8, a global, multi-center, randomized, open-label, Phase III study.
  • 552 patients were enrolled in REACH, a global, multi-center, randomized, open-label, Phase III study.
  • The median PFS for patients who received Rituxan plus FC in CLL8 was 39.8 months.
  • The median PFS for patients who received Rituxan plus FC in REACH was 26.7 months.
  • The hazard ratio for PFS in CLL8 was 0.56, indicating a 44% risk reduction.
  • The hazard ratio for PFS in REACH was 0.76, indicating a 24% risk reduction.

Sources:

  • Genentech, Inc.
  • Biogen Idec (Nasdaq: BIIB)
  • U.S. Food and Drug Administration (FDA)
  • American Cancer Society
  • Blood Weekly