NAPSR News: Eli Lilly's CYRAMZA® gets fourth FDA approval

WASHINGTON - April 27, 2015 - PRLog -- Eli Lilly’s breakthrough cancer treatment CYRAMZA^® (ramucirumab) has received another approval from the U.S Food and Drug Administration (FDA) making this the fourth approved indication for the treatment.  CYRAMZA can now be combined with FOLFIRI (irinotecan, folinic acid, and 5-fluorouracil) chemotherapy for the treatment of patients with metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.

"CYRAMZA now has approvals in advanced or metastatic forms of three of the world's most common and deadly cancers - gastric, non-small cell lung, and colorectal - with four FDA approvals received in just over a year," said Sue Mahony, Ph.D., senior vice president and president, Lilly Oncology. "This progress is encouraging and supports our ongoing development program for CYRAMZA. Achieving today's milestone is another example of Lilly's commitment to people living with gastrointestinal cancers."

Dr. Mahony added, "We are also pleased with the efficient and collaborative reviews we had with the FDA on these submissions." While granted a standard review, this application for CYRAMZA in mCRC was reviewed and approved in approximately nine weeks following its submission to the FDA. All three supplemental applications for CYRAMZA received FDA approval within six months from the time of submission.

FDA approval for this indcation stems from the RAISE Phase II trial which compared CYRAMZA plus FOLFIRI to placebo plus FOLFIRI in people with mCRC who had disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine. The results confirmed that major efficacy endpoints were reached which included the measure of overall survival (OS) and the supportive efficacy outcome measure of progression-free survival (PFS).

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