Eli Lilly Wins FDA Approval For Gastric Cancer Combination Drug
Published: Nov 06, 2014
November 6, 2014
By Jessica Wilson, BioSpace.com Breaking News Staff
Eli Lilly and Co. today announced that the U.S. Food and Drug Administration (FDA) has approved its gastric cancer drug Cyramza (ramucirumab) in combination with paclitaxel (a type of chemotherapy) for the treatment of advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma in patients whose cancer has progressed on or after prior fluoropyrimidine- or platinum-containing chemotherapy.
This is the second approval Cyramza has earned this year. The FDA approved Cyramza as a single agent treatment for patients with these conditions in April.
The FDA based its latest approval of the drug on results from a Phase III trial referred to as RAINBOW, which compared Cyramza plus paclitaxel to placebo plus paclitaxel. RAINBOW was a multinational, randomized, double-blinded, placebo-controlled study initiated in 2010. The study included 665 patients across 27 countries in North America, South America, Europe, Australia and Asia.
In the RAINBOW study, the combination treatment of Cyramza plus paclitaxel extended median overall survival of patients 9.6 months, while the treatment of placebo plus paclitaxel extended it 7.4 months. In addition, Cyramza plus paclitaxel delayed disease progression a statically significant degree longer than the placebo plus paclitaxel treatment. Finally, more patients responded to the combination treatment than to the treatment with paclitaxel and the placebo. Side effects were found, the most serious an increased risk of hemorrhage, including severe and sometimes fatal hemorrhagic events.
“This FDA approval of Cyramza represents another milestone for people battling this devastating and difficult-to-treat disease,” Richard Gaynor, senior vice president of product development and medical affairs for Lilly Oncology, was quoted as saying in a press release from the company. “Lilly is pleased to continue delivering on its commitment to provide new treatment options to people living with cancer and those who care for them.”
In the wake of the April approval of Cyramza as a single agent treatment, Debbie Zelman, president and founder of the international patient advocacy organization, Debbie's Dream Foundation, was quoted as saying in the press release, “As someone who has experienced firsthand the limited options available to treat this devastating disease, I consider this approval to be much needed. This is a significant moment for many patients and their families.”
Zelman founded Debbie’s Dream Foundation after her own gastric cancer diagnosis to raise awareness about gastric cancer, advance funding for research, and provide education and support to those affected by the disease. Debbie’s Dream Foundation and Lilly Oncology have established a partnership to serve the needs of patients with gastric cancer and their caregivers.