FDA Grants Lilly's Ramucirumab Priority Review as a Potential Single-Agent Treatment for Advanced Gastric Cancer
"We are very pleased that the
Priority Review status for a biologics license application, or BLA, means that the
This BLA for ramucirumab was based on data from REGARD, a global, randomized, double-blind Phase III study of ramucirumab plus best supportive care compared to placebo plus best supportive care as a treatment in patients with advanced gastric cancer (including adenocarcinomas of the gastro-esophageal junction) following progression after initial chemotherapy. A registration dossier is also under regulatory review by the
Lilly also studied ramucirumab in combination with paclitaxel for the treatment of advanced gastric cancer in its Phase III RAINBOW trial. The combination-therapy ramucirumab data from that trial will be the basis for separate regulatory applications. Lilly expects top-line results from three additional Phase III trials of
ramucirumab — one each in colorectal, hepatocellular (liver) and lung cancer — in 2014.
About Ramucirumab
Ramucirumab is designed to directly inhibit angiogenesis, a process by which blood vessels supply blood to tumors. Ramucirumab is a human, receptor-targeted antibody that specifically blocks the vascular endothelial growth factor (VEGF) receptor 2 and inhibits downstream signaling involved in the formation and maintenance of aberrant blood vessels that supply blood to tumors.
Ramucirumab, which Lilly gained through its 2008 acquisition of
About Lilly Oncology
For more than five decades, Lilly Oncology has been dedicated to delivering innovative solutions that improve the care of people living with cancer. Lilly Oncology is committed to delivering life-extending and life-enhancing medicines to patients. To learn more about Lilly's commitment to cancer, please visit www.LillyOncology.com.
About
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in
P-LLY
This press release contains forward-looking statements about the potential of ramucirumab as a treatment of various cancers 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. There is no guarantee that future studies will be positive or that ramucirumab will receive regulatory approvals or prove to be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's filings with the
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