The European Commission has granted approval to Bayer HealthCare’s oncology drug Stivarga (regorafenib) for the treatment of patients with unresectable or metastatic gastrointestinal stromal tumors (GIST) who have progressed or shown intolerance to prior treatment with imatinib and sunitinib.
Regorafenib is an oral multi-kinase inhibitor that works to bind different kinases within angiogenesis and oncogenesis, mechanisms involved in tumor progression and spread. The drug has already been approved in the EU for the treatment of patients with metastatic colorectal cancer (mCRC). The new European approval was supported by positive results from the pivotal Phase III study GRID, in which the drug achieved a statistically meaningful improvement in progression-free survival (PFS) versus placebo. Results from the GRID study were presented by Bayer at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) and published in The Lancet in 2012. Stivarga is co-marketed by Bayer and Amgen subsidiary Onyx.
Dr. Joerg Moeller, Member of the Bayer HealthCare Executive Committee and Head of Global Development, said, “Following the approval of Stivarga for GIST in several countries worldwide, including the U.S. and Japan, we are delighted to offer patients in Europe a new option for treating this rare yet relentless cancer.”
Gastrointestinal stromal tumors (GIST) are the leading form of sarcoma that grows on the muscle wall of the gastrointestinal tract. GIST becomes lethal once it has spread to other parts of the body or is impossible to be surgically removed. The disease affects 11 to 20 patients per million annually worldwide. “GIST is a highly aggressive cancer that can go undetected for years and, at the point of diagnosis, most patients have already progressed to advanced stages of disease. Survival rates are low and treatments are limited after imatinib and sunitinib,” said Professor Jean Yves-Blay, GRID investigator and Head of the Medical Oncology Department, Centre Leon Berard at Université Claude Bernard in Lyon, France. Professor Yves-Blay reported that regorafenib increased PFS fivefold compared to placebo in the trial.
Bayer said Stivarga’s second indication approval was secured within one year of its application.
Stivarga along with other newly launched products played a part in the company sales growth this second quarter for Bayer’s HealthCare group. The company reported a 0.9 percent increase estimated at EUR 4,845 million for the business unit. “This growth continued to be driven by our recently launched pharmaceutical products,” said Management Board Chairman Dr. Marijn Dekkers. Stivarga was included in the list of recently launched products as well as another cancer treatment Xofigo, eye treatment Eylea, pulmonary hypertension drug Adempas, and anticoagulant Xarelto.