Supplemental BLAs submitted for Rituxan for chronic lymphocytic leukemia

Genentech and Biogen Idec announced that they submitted two supplemental Biologics License Applications (sBLAs), along with a priority review request, to the FDA for Rituxan (rituximab) plus standard (fludarabine and cyclophosphamide) chemotherapy for patients with previously untreated or treated chronic lymphocytic leukemia (CLL). The sBLAs are based on positive results from two global, multi-center, randomized, open-label Phase 3 studies known as CLL8 and REACH. These studies showed that Rituxan plus standard chemotherapy for CLL extended the time patients lived without the cancer advancing (the studies' primary end point, also known as progression-free survival or PFS) compared to those receiving chemotherapy alone. In CLL8, previously untreated patients who received Rituxan plus chemotherapy had a 69 percent improvement in PFS compared to those who received chemotherapy alone. In REACH, patients whose cancer relapsed after previous treatment had a 54 percent improvement in PFS after receiving Rituxan plus chemotherapy compared to patients receiving chemotherapy alone.  Secondary endpoints were overall survival, event-free survival, duration of response, response rate and complete response.

Rituxan is a therapeutic antibody indicated for the treatment of Non-Hodgkin's Lymphoma (NHL) and in combination with methotrexate for moderate-to-severe rheumatoid arthritis (RA) in adults.

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