FDA approves lower dose of cabazitaxel in treatment of mCRPC


Yesterday, in line with previously reported data, the US Food and Drug Administration (FDA) approved the used of a 20 mg/ml dose of cabazitaxel (Jevtana) in the treatment of men with metastatic, castration-resistant prostate cancer (mCRPC). However, the use of this dose of cabazitaxel is currently approved only for men who have previously been treated with docetaxel-based chemotherapy.

It is going to be an open question  whether payers will be willing to cover the costs of the use of cabazitaxel at this dose level as first-line chemotherapy in the treatment of mCRPC (i.e., “off-label”, prior to docetaxel-based chemotherapy). There will certainly be some physicians who recommend this to their patients.

The FDA approval is based on the data from the PROSELICA trial of cabazitaxel in some 1,200 patients with mCRPC, all of whom had received prior docetaxel-based chemotherapy. This information comes from an e-mail issued by the American Society of Clinical Information, in cooperation with the FDA, to all of its US-based members.

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