Eli Lilly receives FDA Priority Review approval for olaratumab

5 May 2016 (Last Updated May 5th, 2016 18:30)

American pharmaceutical company Eli Lilly and Company has received Priority Review approval from the US Food and Drug Administration (FDA), for its biologics license application (BLA) for olaratumab.

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American pharmaceutical company Eli Lilly and Company has received Priority Review approval from the US Food and Drug Administration (FDA) for its biologics license application (BLA) for olaratumab.

Olaratumab is a PDGFRa antibody, which in combination with doxorubicin, serves as a treatment for people affected with advanced soft tissue sarcoma (STS) that fails to respond to curative treatment with radiotherapy or surgery.

Eli Lilly has bagged additional designations for olaratumab from the FDA that includes breakthrough therapy, fast track and orphan drug, for this indication.

Preliminary clinical evidence reveals that the drug might be capable of resulting into substantial improvement over available therapy on a clinically significant endpoint.

"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."

Lilly Oncology product development and medical affairs senior vice-president Dr Richard Gaynor 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 BLA submission for olaratumab was completed in the first quarter of this year and was based on the results from a Phase II trial, JGDG, an open-label, randomised test that compared olaratumab in combination with doxorubicin chemotherapy to doxorubicin alone in patients suffering from advanced STS.

Lilly has also submitted an application for olaratumab to the European Medicines Agency (EMA) during the same period and is currently being reviewed under an accelerated assessment schedule.


Image: Undifferentiated soft tissue sarcoma in left lung of young child. Photo: courtesy of ThatPeskyCommoner.