Eli Lilly’s cancer drug candidate scores FDA priority review

pharmafile | May 5, 2016 | News story | |  Eli Lilly, US FDA, oncology, regulation 

US drugmaker Eli Lilly (NYSE: LLY) said the US Food and Drug Administration (FDA) has granted priority review for its drug candidate to treat cancerous tumours.

The company said its experimental monoclonal antibody olaratumab is being developed as a combination therapy with doxorubicin to treat advanced soft tissue sarcoma (STS).

Richard Gaynor, senior vice president, product development and medical affairs for Lilly Oncology, said: “We are encouraged that the FDA has granted Priority Review for olaratumab as a potential treatment for advanced soft tissue sarcoma. We are hopeful that, if approved, olaratumab will provide a meaningful addition to the limited treatment options for this rare and difficult-to-treat disease.”

The FDA has already granted breakthrough therapy, fast track and orphan drug designations for olaratumab in this indication.

Lilly’s application for olaratumab to the European Medicines Agency (EMA), earlier this year, is currently being reviewed under an accelerated assessment schedule.

Priority review status for olaratumab reinforces that the trial drug is a potential medicine that treats a serious condition and can provide significant improvement in the treatment of people with advanced STS, the company said in a statement.

Anjali Shukla

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