The CHMP has given a positive opinion to Eisai’s breast cancer drug Halaven (eribulin) in the treatment of patients with advanced disease.
The treatment has been recommended by the CHMP as a monotherapy for locally advanced (LA) or metastatic breast cancer (MBC) in patients who have progressed after therapy with an anthracycline and a taxane, unless patients were not suitable for these treatments.
In Phase III trials, Halaven has been proven to improve overall survival by 2.7 months compared to the current treatment of choice.
“This is very positive news for women with pretreated locally advanced or metastatic breast cancer,” said Professor Gordon McVie, senior consultant at the European Institute of Oncology, Milan. “Halaven is a promising therapy for these patients who currently have very limited treatment options.”
Other drugs recommended for marketing authorisation by the CHMP this month include:
· Sanofi-aventis’ Jevtana (cabazitaxel) for the treatment of patients with hormone refractory metastatic prostate cancer (in combination with prednisone or prednisolone)
· Pravafenix (fenofibrate/pravastatin) from Laboratoires S.M.B. S.A., for the treatment of adults at high risk of coronary heart disease with mixed dyslipidaemia
· Glaxo’s adjunctive epilepsy treatment Trobalt (retigabine).
The CHMP also gave positive opinions for the following extensions of indication:
· Bristol-Myers Squibb’s Baraclude (entecavir), to include treatment of chronic hepatitis B virus infection and decompensated liver disease
· INO Therapeutics’ INOmax (nitric oxide), to include treatment of pulmonary hypertension peri- and post heart surgery
· Janssen-Cilag’s Prezista (darunavir), to include the second-line treatment of HIV infection in adults.