Jevtana(cabazitaxel)

Oncology· 772 cited findings· 1 source document

What the regulatory reviews say

Jevtana (cabazitaxel) is a drug indicated for the treatment of prostate cancer. Regulatory review documents show a median overall survival of 12.7 months and 15.1 months, with an overall survival hazard ratio of 0.70 (p-value <0.0001). The median progression-free survival was 2.8 months, with a hazard ratio of 0.74 (p-value <0.0001). The tumor response rate (RECIST) was 4.4%, and the PSA response rate was 17.8% and 39.2%.

Regarding safety, 39.4% of patients experienced Grade >=3 treatment-emergent adverse events (TEAEs). Specific adverse events included diarrhea (Grade >=3) at 0.3%, vomiting (all grades) at 10.2% and 22.6%, and nausea (Grade >=3) at 0.3% and 1.9%. Hepatobiliary disorders (all grades) were reported in 1.6% of patients, while ear and labyrinth disorders (all grades) occurred in 3.5% of patients, with 0% for Grade >=3.

The Marketing Authorisation application was submitted on 20 April 2010, and the CHMP issued a positive opinion on 20 January 2011, recommending the granting of the marketing authorization. The Marketing Authorisation was approved in the USA on 17 June 2010.

Key figures — cited to the source page

Median overall survival	12.7	Sanofi — Jevtana EMA EPAR public assessment report (EMEA/H/C, p.45
Overall survival hazard ratio	0.70	Sanofi — Jevtana EMA EPAR public assessment report (EMEA/H/C, p.45
Median progression-free survival	2.8	Sanofi — Jevtana EMA EPAR public assessment report (EMEA/H/C, p.50
Progression-free survival hazard ratio	0.74	Sanofi — Jevtana EMA EPAR public assessment report (EMEA/H/C, p.50
TEAEs (grade >=3)	39.4	Sanofi — Jevtana EMA EPAR public assessment report (EMEA/H/C, p.55
Diarrhoea (grade >=3)	0.3	Sanofi — Jevtana EMA EPAR public assessment report (EMEA/H/C, p.55
Marketing Authorisation application submission date	20 April 2010	Sanofi — Jevtana EMA EPAR public assessment report (EMEA/H/C, p.4
CHMP positive opinion date	20 January 2011	Sanofi — Jevtana EMA EPAR public assessment report (EMEA/H/C, p.5

Source documents

Sanofi — Jevtana EMA EPAR public assessment report (EMEA/H/C/002018, 2011) (2011)

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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.