The European Commission has approved Bayer HealthCare's Stivarga (regorafenib) tablets for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have previously been treated with, or are not considered candidates for, available therapies. These include fluoropyrimidine based chemotherapy, an anti VEGF therapy and an anti EGFR therapy.
“Following the approval of Stivarga for mCRC in several countries worldwide, including the US and Japan, we are pleased to offer patients in Europe a new treatment option,” said Kemal Malik, MD, member of the Bayer HealthCare Executive Committee and head of Global Development. “At Bayer, we are committed to developing treatments that can improve the lives of patients, and from these data anticipate that Stivarga can positively impact those suffering from mCRC.”
“Colorectal cancer is one of the most prevalent cancer types for which there is a real unmet need for new treatment options. Currently people with early CRC can have surgery to remove the cancer, preceded or followed by radiotherapy and/or chemotherapy to prevent it coming back. Yet for many people their disease progresses to other parts of the body, dramatically reducing their chance of being cured,” said Prof. Eric Van Cutsem, lead CORRECT investigator, University Hospital Gasthuisberg Leuven, Belgium. “The multi-targeted action of Stivarga provides a new option in targeting mCRC. In the CORRECT trial, Stivarga significantly improved both overall and progression-free survival in this difficult-to-treat population. These data show that Stivarga can provide new treatment option for patients with mCRC,” van Cutsem concluded.
The approval of Stivarga was based on data from the pivotal phase III CORRECT (Colorectal cancer treated with regorafenib or placebo after failure of standard therapy) trial. Full results from the CORRECT study were presented at the 48th Annual Meeting of the American Society of Clinical Oncology.
Stivarga is approved for the treatment of patients with mCRC and gastrointestinal stromal tumours (GIST) in several countries, including the US and Japan.
Stivarga (regorafenib) is an oral multi-kinase inhibitor that inhibits various kinases within the mechanisms involved in tumor growth and progression – angiogenesis, oncogenesis and the tumour microenvironment. In preclinical studies, Stivarga inhibits several angiogenic VEGF receptor tyrosine kinases that play a role in tumor neoangiogenesis (the growth of new blood vessels). It also inhibits various oncogenic and tumor microenvironment kinases including VEGFR 1-3, KIT, RET, PDGFR, and FGFR, which individually and collectively impact upon tumour growth, formation of a stromal microenvironment and disease progression.
Stivarga is a Bayer compound developed by Bayer and jointly promoted by Bayer and Onyx in the USA. In 2011, Bayer entered into an agreement with Onyx, under which Onyx receives a royalty on all global net sales of regorafenib in oncology.
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The Bayer Group is a global enterprise with core competencies in the fields of health care, agriculture and high-tech materials.
The Bayer Group is a global enterprise with core competencies in the fields of health care, agriculture and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 18.6 billion (2012), is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany.