It will be a tense time for Abbott in September when a revised meta-analysis of two failed trials of its prostate cancer agent Xinlay (atrasentan) will come before the US Food and drug Administration’s Oncologic Drugs Advisory Committee as a treatment for advanced prostate cancer that is refractory to hormone therapies [[15/12/04d]].
The initial meta-analysis, presented at ASCO in 2004, assessed a 2.5 mg dose and showed a statistically significant 20% reduction in time to disease progression compared with placebo. The revised analysis, presented at ASCO this year, assessed data on a 10 mg dose in the same two trials. Results showed a non-significant 14% reduction in progression versus placebo (p=0.045).
The following day, Celgene’s Revlimid (lenalidomide) will be reviewed for use in myelodysplastic syndromes and GlaxoSmithKline’s nucleoside analogue Arranon (nelarabine) is slated for review the same day for treatment of T-cell acute lymphoblastic leukemia and lymphoma. Celgene presented positive Phase II data for Revlimid at the American Society of Clinical Oncology annual meeting in May, showing a 70% cytogenetic response rate. Celgene also reported that 66% of the 146 patients who were transfusion dependent at baseline achieved transfusion independence and a median hemoglobin increase of 5.3 g/dL [[11/04/05f]].
The committee will also review GSK’s prodrug Arranon (nelarabine). The agent has a priority review action date of October 29 for the treatment of relapsed or refractory T-cell acute lymphoblastic leukemia and lymphoma. GSK completed a rolling NDA submission of Arranon April 29 based on Phase II data in both adults and children.