FDA Grants Priority Review for Lilly's Olaratumab, an Investigational Medicine for Advanced Soft Tissue Sarcoma
Lilly has received additional designations for olaratumab from the
"We are encouraged that the
Providing Priority Review status for olaratumab reinforces that olaratumab is a potential medicine that treats a serious condition and can provide significant improvement in the treatment of people with advanced STS. Submission was completed in the first quarter of 2016.
The BLA submission for olaratumab was based upon the results from a pivotal Phase 2 trial, JGDG, an open-label, randomized study that compared olaratumab in combination with doxorubicin chemotherapy to doxorubicin alone in patients with advanced STS not amenable to curative treatment with surgery or radiotherapy. Results from JGDG were presented at the 2015
Lilly also submitted olaratumab to the
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 3 trial of olaratumab and doxorubicin in advanced STS is currently recruiting adult patients (ClinicalTrials.gov Identifier: NCT02451943).
Sarcomas are a diverse and relatively rare type of cancer that usually develop in the connective tissue of the body, which include fat, blood vessels, nerves, bones, muscles, deep skin tissues and cartilage. Soft tissue sarcoma (STS) is a complex disease with multiple subtypes, making it very difficult to treat. According to the
About Lilly Oncology
For more than 50 years, Lilly has been dedicated to delivering life-changing medicines and support to people living with cancer and those who care for them. Lilly is determined to build on this heritage and continue making life better for all those affected by cancer around the world. To learn more about Lilly's commitment to people with cancer, please visit www.LillyOncology.com.
About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and newsroom.lilly.com/social-channels. P-LLY
Lilly Forward-Looking Statement
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about the potential of olaratumab as a potential treatment of advanced soft tissue sarcoma and reflects Lilly's current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that future study results and patient experience will be consistent with the study findings to date. There can also be no guarantee that olaratumab will receive regulatory approval or that, if approved, it will prove to be commercially successful. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, please see the company's latest Forms 10-K and 10-Q filed with the
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