FDA Grants Priority Review to Advanced Soft Tissue Sarcoma Tx
Lilly announced that the Food and Drug Administration (FDA) has granted Priority Review for the Biologics License Application (BLA) for olaratumab, in combination with doxorubicin, for the potential treatment of advanced soft tissue sarcoma (STS) not amenable to curative treatment with radiotherapy or surgery.
The BLA submission was supported by data from the open-label, randomized, Phase 2 trial, JGDG, which evaluated olaratumab in combination with doxorubicin vs. doxorubicin alone in patients with advanced STS not amenable to curative treatment with surgery or radiotherapy. Findings from the study were presented at the 2015 American Society of Clinical Oncology annual meeting and the 2015 Connective Tissue Oncology Society annual meeting.
Olaratumab previously received various designations from the FDA for the STS indication, including Breakthrough Therapy, Fast Track and Orphan Drug Status. A Phase 3 study of olaratumab in combination with doxorubicin for advanced STS is ongoing.
Olaratumab is a human IgG1 monoclonal antibody designed to disrupt the PDGF Receptor-α (platelet-derived growth factor receptor α) pathway on tumor cells and on cells in the tumor microenvironment.
For more information call (800) 545–5979 or visit Lilly.com.