On June 17, 2010, the US Food and Drug Administration (FDA) approved the use of cabazitaxel (Jevtana®) injection, with prednisone, for the treatment of castration-resistant distant metastatic (M1) prostate cancer that was previously treated with a docetaxel-containing treatment regimen. Cabazitaxel (Jevtana®) is an antineoplastic agent belonging to the taxane class. Cabazitaxel (Jevtana®) is a microtubule inhibitor that binds to tubulin to promote its assembly into microtubules, while simultaneously inhibiting disassembly. This leads to the stabilization of microtubules and the hindering of microtubule depolymerization and cell division. The result is an interruption of mitotic and interphase cellular functions, cell arrest, and limited tumor cell proliferation. Cabazitaxel (Jevtana®) has demonstrated antitumor activity in docetaxel-sensitive tumors. Additionally, it has demonstrated antitumor activity in tumor models that are insensitive to chemotherapy that contained docetaxel.
This FDA approval was based primarily on the results of a single, randomized, open-label, international trial of 755 patients with castration-resistant distant metastatic (M1) prostate cancer previously treated with docetaxel-containing regimens. Individuals were treated with cabazitaxel (Jevtana®) in combination with prednisone until disease progression, death, unacceptable toxicity, or completion of 10 cycles of therapy. The results showed that treatment with cabazitaxel (Jevtana®) in combination with prednisone for hormone-refractory metastatic prostate cancer resulted in a statistically significant reduction in the risk of death by 30 percent (p<0.0001). A median overall survival improvement of 15.1 months was observed in the cabazitaxel (Jevtana®) combination group compared to 12.7 months in the control combination treatment. Individuals treated with the cabazitaxel (Jevtana®) combination also experienced a significant improvement in median progression-free survival of 2.8 months compared to 1.4 months in the control arm (p<0.0001). However, this superior efficacy came at the cost of relatively high toxicity, with the cabazitaxel (Jevtana®) combination causing a considerable decrease in white blood cell count, resulting in 82 percent of patients having grade 3/4 neutropenia.
There may be additional indications contained in the Policy section of this document due to evaluation of criteria highlighted in the Company’s off-label policy, and/or review of clinical guidelines issued by leading professional organizations and government entities.
Policy: MA08.012c:Off-label Coverage for Prescription Drugs and/or Biologics