Lilly drug to receive fast US review in soft tissue sarcoma
The US Food and Drug Administration (FDA) will give Eli Lilly’s olaratumab a fast review in advanced soft tissue sarcoma (STS), for patients not amenable to curative treatment with radiotherapy or surgery.
The filing comes as Lilly looks to new drugs to replace lost sales after former blockbuster antidepressant Cymbalta (duloxetine) lost patent protection in Europe and the US several years ago.
Lilly’s orphan drug had already been designated as a Breakthrough Therapy, meaning it could be an advance in an area where existing therapies are considered inadequate, and the FDA also allowed it a fast track development programme.
The drug will now receive a six-month Priority Review instead of the standard 10, after Lilly’s filing in the first quarter of this year.
Lilly’s filing was based upon results from a pivotal phase 2 trial, JGDG, an open-label, randomised study comparing olaratumab in combination with doxorubicin chemotherapy to doxorubicin alone, in patients with advanced STS not amenable to curative treatment with surgery or radiotherapy.
The drug is also receiving an accelerated assessment in Europe following a filing in the first quarter of this year.
Olaratumab is a human IgG1 monoclonal antibody that is designed to disrupt the PDGF Receptor-α (platelet-derived growth factor receptor α) pathway on tumour cells and on cells in the tumour microenvironment. This means it may cause anticancer activity by targeting tumour cells directly, as well as cells that surround and support tumour growth.
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