Cabazitaxel, a new molecular entity, is indicated as 2nd-line therapy for patients with metastatic castration- resistant prostate cancer. Cabazitaxel is licensed in the U.S. and received a positive opinion of the EMA’s Committee for Medicinal Products for Human Use based on the results of a phase III trial which investigated cabazitaxel + prednisone in comparison to mitoxantrone + prednisone. Median overall survival showed a statistically significant improvement for patients treated with cabazitaxel in comparison to mitoxantrone (HR=0.70, p<0.0001). However, the difference was only 2.4 months in comparison to a drug with an unknown impact on survival itself. Also, as this new therapy is associated with frequent and sometimes life-threatening adverse events, data on quality-of-life, which are still missing, are of utmost interest. Further questions which need to be addressed are the efficacy of cabazitaxel in comparison to docetaxel in the 1st-line setting.
In summary, reliable estimates of the drug’s true significance are not possible to date.