Eli Lilly Plans Additional Regulatory Filing for Cancer Drug CyramzaBy
Eli Lilly plans to initiate a regulatory submission in the first half of 2015 for Cyramza (ramucirumab) for treating metastatic colorectal cancer (mCRC) following positive Phase III clinical trials. The drug was approved earlier this year as a a single agent for treating advanced or metastatic gastric or gastroesophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy.
The company reported that a Phase III study of ramucirumab in combination with chemotherapy in patients with mCRC met its primary endpoint of overall survival. The global, randomized, double-blind study compared ramucirumab plus FOLFIRI to placebo plus FOLFIRI as a second-line treatment in patients with mCRC after treatment with bevacizumab, oxaliplatin, and a fluoropyrimidine in the first-line setting.
“We now have four Phase III ramucirumab trials that improved survival in three of the world’s most common and deadly cancers–gastric, lung, and colorectal–supporting global regulatory submissions in multiple indications,” said Richard Gaynor, senior vice president, product development and medical affairs for Lilly Oncology, in a company press release. The company has several studies underway or planned to investigate Cyramza as a single agent and in combination with other anti-cancer therapies for the treatment of multiple tumor types.
Ramucirumab is a vascular endothelial growth factor (VEGF) Receptor 2 antagonist that specifically binds VEGF Receptor 2 and blocks binding of VEGF receptor ligands VEGF-A, VEGF-C, and VEGF-D. VEGF Receptor 2 is an important mediator in the VEGF pathway. In an in vivo animal model, ramucirumab inhibited angiogenesis. Angiogenesis is a process by which new blood vessels form to supply blood to normal healthy tissues as well as tumors, enabling the cancer to grow. Some tumors create proteins called VEGF. These proteins attach to the VEGF receptors of blood vessel cells causing new blood vessels to form around the tumors, enabling growth. Blocking the VEGF protein from linking to the blood vessels helps to inhibit tumor growth by slowing angiogenesis and the blood supply that feeds tumor.
Source: Eli Lilly