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Regulators in Europe approve Zeltia’s oncology drug Yondelis for ovarian cancer.
Yondelis can now be used for the new indication in combinationwith Johnson & Johnson’s Doxil (doxorubicin).
Yondelis (trabectedin) which isalready approved for the treatment of advanced soft tissue sarcoma, gota positive recommendation for ovarian cancer in September from theEuropean Medicines Agency’s Committee for Medicinal Products for HumanUse, so the decision by the EuropeanCommission was expected.
Thecompany, based in Madrid, said the combo has been approved for usein the 27 countries of the European Union, plus Norway, Iceland andLiechenstein.
Yondelis will be launched first in the UK, Austria,Germany, Denmark, Sweden, Finland and Norway, “where it is notnecessary to negotiate prices”.
The European approval is incontrast to the stance being taken by regulators across the Atlantic.In September, the US Food and Drug Administration issued a completeresponse letter on the Yondelis/Doxil combination for ovarian cancerand requested additional information, including overall survival datafrom the company’s ongoing pivotal trial and further clinicalpharmacology studies.
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