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European regulators greenlight U.S. biotech's kidney cancer drug
2017年6月23日 / 中午11点55分 / 1 个月内

European regulators greenlight U.S. biotech's kidney cancer drug

1 分钟阅读

June 23 (Reuters) - European regulators on Friday recommended approving Aveo Pharmaceuticals Inc's drug to treat kidney cancer, marking a victory for the U.S. biotech that has faced setbacks in bringing the drug to market.

The European Medicines Agency (EMA) said experts at the Committee for Medicinal Products for Human Use (CHMP) had backed medicinal product tivozanib, or Fotivda, for marketing approval as a first-line treatment for advanced renal cell carcinoma, or kidney cancer.

The drug was also backed for treating adult patients with advanced kidney cancer who met certain criteria and had received one prior treatment with cytokine therapy, the EMA said.

Recommendations for marketing approval by the CHMP are normally endorsed by the European Commission within a couple of months.

Specialty pharmaceutical business EUSA Pharma was granted the European rights to tivozanib for the treatment of kidney cancer by Aveo. (Reporting by Esha Vaish in Bengaluru; Editing by Sai Sachin Ravikumar)

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