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Home Industry News Lilly receives CHMP recommendation for soft tissue sarcoma therapy

Lilly receives CHMP recommendation for soft tissue sarcoma therapy

21st September 2016

Lilly has announced that its new drug olaratumab has been recommended for European regulatory approval for the treatment of adults with advanced soft tissue sarcoma.

The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended a conditional marketing authorisation for olaratumab in combination with doxorubicin for treating advanced soft tissue sarcoma not amenable to treatment with radiotherapy or surgery and who have not been previously treated with doxorubicin.

Lilly's submission for the drug was supported by data from a phase II trial demonstrating the safety and efficacy of the new therapy. The firm will need to provide results from the ongoing phase III study ANNOUNCE as part of the terms of the conditional marketing authorisation.

If approved, olaratumab will be marketed under the trade name Lartruvo, with a final decision from the European Commission expected within the next three months.

Dr Richard Gaynor, senior vice-president of product development and medical affairs for Lilly Oncology, said: "Advanced soft tissue sarcoma is a rare disease that is difficult to treat, and this milestone brings us one step closer to providing physicians in Europe with a new option that they can offer to their patients."

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