Approval Date
June 17, 2010

Release Date
July 19, 2010


Taxane antimicrotubule

In combination with prednisone, hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen.

Active Ingredient
Cabazitaxel 60mg/1.5mL; soln for IV infusion after dilution; contains polysorbate 80, diluent contains ethanol.

Agency Roster
Saatchi & Saatchi Wellness (consumer)
Saatchi & Saatchi Healthcare Professional Advertising (pro.)

Marketing Strategy/Execution
Sanofi-Aventis is using online disease awareness to educate the oncology community about its newly approved treatment for advanced prostate cancer, Jevtana. Consumer-facing website, by Saatchi & Saatchi Wellness, features in-depth educational content and safety information about a disease which can be quite confusing for patients. HCPs are directed to the portal Professional-oriented ads by Saatchi & Saatchi Healthcare Professional Advertising are running in at least two publications, MPR and Clinical Advisor. Jevtana gives oncologists a new way to treat those who have previously been on a docetaxel-based treatment regimen, like Sanofi’s own Taxotere, the top-selling chemotherapy. As the only drug to show significant survival benefit (2.4 months) in second-line treatment, Jevtana’s price could be north of $50,000/year (an analyst estimate relative to what Dendreon charges for first-line prostate cancer treatment Provenge and its four-month benefit). Generic versions of Taxotere should begin appearing in late 2010 in the US and EU, so Jevtana gives Sanofi a way to offset the revenue loss to genericization, particularly if the firm initiates expansion into the first-line setting. A black box warning on neutropenia and severe hypersensitivity could limit earlier use, though, especially given Dendreon’s availability.

Also in the Pipeline (courtesy of Adis R&D Insight)

Drug: Sprycel
Manufacturer:Bristol-Myers Squibb
Indication: Prostate cancer, treatment-experienced patients
Active ingredient: Dasatinib
Phase: II

Drug: MDV3100
Manufacturer: Astellas Pharma
Indication: Prostate cancer, hormone-refractory
Active ingredient: MDV 3100
Phase: III

Drug: AZD 4054
Manufacturer: Dendreon
Indication: Prostate cancer, hormone-refractory
Active ingredient: Zibotentan
Phase: III

Source: Wolters Kluwer Pharma Solutions

Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.

Clinical Trials
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.

Adverse Reactions
Not recommended.

Pretreat with IV antihistamine, corticosteroid, and H2 blocker 30 min before each dose (see literature) and with antiemetic (IV or oral as needed). 25mg/m2 by IV infusion over 1 hour every 3 weeks, with oral prednisone 10mg/day during treatment. Do not treat if neutrophil count ≤1,500 cells/mm3. Prolonged grade ≥3 neutropenia (>1 week), febrile neutropenia, grade ≥3 diarrhea: delay treatment and/or reduce dose to 20mg/m2 (see literature). Discontinue if reactions persist after dosing at 20mg/m2.

<18yrs: not recommended.

Do CBC weekly in 1st cycle and before each subsequent cycle. Increased risk of neutropenia complications; consider G-CSF prophylaxis. Hepatic impairment: not recommended. Severe renal impairment (CrCl <30mL/min) or ESRD. Elderly (increased susceptibility to adverse reactions); monitor closely. Pregnancy (Cat.D; avoid). Nursing mothers: not recommended.

Baseline neutrophil count ≤1,500cells/mm3. Allergy to polysorbate 80.