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The only microtubule inhibitor approved in combination with prednisone for treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing regimen.

MORE Survival:

Sustained an Overall Survival Advantage in mCRPC Patients at 2 Years1,2

The TROPIC trial was a randomized, open-label, international, multi-center study of JEVTANA 25 mg/m2 (n=378) vs. mitoxantrone 12 mg/m2 (n=377) in patients with mCRPC previously treated with a docetaxel-containing treatment regimen. The primary endpoint was median overall survival.


Primary Endpoint: Median Overall Survival1,4

Median overall survival: 30% reduced risk of death at 12.8 months and 28% reducted risk of death at 2 years
  • 12.8 month follow-up: 15.1 months (95% CI: 14.1-16.3) median overall survival for patients receiving JEVTANA 25 mg/m2 vs 12.7 months (95% CI: 11.6-13.7) with mitoxantrone (P<0.0001). Number of deaths were 234 (62%) with JEVTANA vs 279 (74%) with mitoxantrone.
  • 2-year follow-up: number of deaths were 350 (93%) with JEVTANA vs 366 (97%) with mitoxantrone.
  • Due to study limitations, the 2-year advantage is the probability of survival with a data cutoff of March 2010.

JEVTANA 20 mg/m2 Dose Was Validated in the PROSELICA Trial Delivering a Median Overall Survival Comparable to 25 mg/m2 1

The PROSELICA trial was a non-inferiority, multicenter, randomized, open-label study of JEVTANA 20 mg/m2 (n=598) vs. JEVTANA 25 mg/m2 (n=602) in patients with mCRPC previously treated with a docetaxel-containing regimen. The primary endpoint was overall survival.


Per-Protocol Population:
Median Overall Survival4

  • No notable difference in overall survival was observed in subgroups based on the stratification factors, ECOG performance status score, measurability of disease, or region.1
  • Per intent-to-treat population: 13.4 months (95% CI: 12.2 - 14.9) median overall survival JEVTANA 20 mg/m2 and 14.5 months (95% CI: 13.5 - 15.3) for JEVTANA 25 mg/m2 (HR = 1.024) (97.78% CI: 0.886 - 1.184).1
View Adverse Reactions in 20 mg/m2 vs 25 mg/m2

NCCN CATEGORY 1

JEVTANA is a NCCN designated Category 1 second-line therapy for mCRPC.3

SEE TRIALS &
PATIENTS STUDIED

IMPORTANT SAFETY INFORMATION

WARNING: NEUTROPENIA AND HYPERSENSITIVITY

  • Neutropenic deaths have been reported. Obtain frequent blood counts to monitor for neutropenia. JEVTANA is contraindicated in patients with neutrophil counts of ≤1,500 cells/mm3. Primary prophylaxis with G-CSF is recommended in patients with high-risk clinical features.
  • Severe hypersensitivity reactions can occur and may include generalized rash/erythema, hypotension and bronchospasm. Severe hypersensitivity reactions require immediate discontinuation of the JEVTANA infusion and administration of appropriate therapy. Patients should receive premedication. JEVTANA is contraindicated in patients who have a history of severe hypersensitivity reactions to cabazitaxel or to other drugs formulated with polysorbate 80.

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