he oncology compound regorafenib (Stivarga) from Bayer has been recommended for approval by the European Committee for Medicinal Products for Human Use (CHMP) for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib. The decision of the European Commission on the approval is expected in the third quarter of 2014. Stivarga is already approved in the EU for the treatment of patients with metastatic colorectal cancer (mCRC).
“The recommendation by the CHMP for Stivarga brings us one step closer to fulfilling a serious unmet medical need for patients suffering from this rare but aggressive cancer” said Dr. Joerg Moeller, member of the Bayer HealthCare executive committee and head of global development. “As an oral multi-kinase inhibitor that targets multiple tumor pathways, Stivarga would provide a new option for those patients with GIST who have no other approved treatment alternatives. At Bayer, we are committed to developing treatments that truly make a difference for patients battling the toughest of cancers.”
The CHMP decision is based on the results of the pivotal Phase 3 GRID trial which showed that regorafenib plus best supportive care (BSC) significantly improved progression-free survival (PFS) compared to placebo plus BSC in patients with metastatic and/or unresectable GIST who were previously treated with imatinib and sunitinib. The median PFS was 4.8 months in the regorafenib arm versus 0.9 months in the placebo arm. The increase in PFS was consistent independent of patient age, sex, geographic region, prior lines of treatment or ECOG performance status.
The most frequently reported drug-related adverse events in regorafenib-treated patients versus placebo-treated patients, respectively, were: asthenia/fatigue, hand-foot skin reaction (HFSR)/palmar-plantar erythrodysesthesia (PPE), diarrhea, decreased appetite and food intake, hypertension, mucositis, dysphonia, infection, pain (not otherwise specified), decreased weight, gastrointestinal and abdominal pain, rash, fever and nausea. The most serious adverse drug reactions in patients receiving Stivarga are hepatotoxicity, hemorrhage, and gastrointestinal perforation.
Results from the study were presented at the Annual Meeting of the American Society of Clinical Oncology (ASCO) in June 2012 and published in November 2012 in the journal The Lancet.
Regorafenib is approved under the brand name Stivarga in several countries worldwide, including the United States, Europe and Japan, for the treatment of patients with mCRC. In several countries, including the United States and Japan, the product has also been approved for the treatment of GIST.
Date: June 27, 2014
Source: Bayer HealthCare
Filed Under: Drug Discovery