FDA Grants Priority Review for Lilly’s BLA for Cancer mAb

The US Food and Drug Administration (FDA) has granted priority review for Eli Lilly and Company’s biologics license application (BLA) for olaratumab, a PDGFRα antagonist, in combination with doxorubicin, for the potential treatment of people with advanced soft tissue sarcoma (STS) not amenable to curative treatment with radiotherapy or surgery.

Lilly has received additional designations for olaratumab from the FDA, including breakthrough therapy, fast track and orphan drug, for this indication. According to the FDA, breakthrough therapy designation is a process designed to expedite the development of a potential medicine that is intended to treat a serious condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint.

Lilly also submitted olaratumab to the European Medicines Agency in the first quarter of 2016, and the application is currently being reviewed under an accelerated assessment schedule. Its submission to the FDA was completed in the first quarter of 2016.

Olaratumab is a human IgG1 monoclonal antibody that is designed to disrupt the PDGF Receptor-α (platelet-derived growth factor receptor α) pathway on tumor cells and on cells in the tumor microenvironment. This means it may cause anticancer activity by targeting tumor cells directly, as well as cells that surround and support tumor growth. A Phase III trial of olaratumab and doxorubicin in advanced STS is currently recruiting adult patients

Source: Eli Lilly and Company

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