The Korean health authorities said they would update approval condition for Stivarga (regorafenib) after learning that Europe had a report of peripheral neuropathy in a patient who took the liver cancer medication.
|Bayer’s liver cancer treatment Stivarga
The Ministry of Food and Drug Safety said Tuesday it would review the European Commission’s safety information about regorafenib and reflect it on the local license.
Peripheral neuropathy, one of the side effects of anticancer drugs, causes infections in peripheral nerves at the tips of fingers and toes and makes them feel numb. In severe cases, patients find it difficult to even walk because of the poor sense of balance.
Developed by Bayer, Stivarga is indicated in Korea for treatment of patients with metastatic colorectal cancer who have been treated with chemotherapy based on fluoropyrimidine-based drugs, anti-VEGF therapy, and anti-EGFR treatment (RAS normal).
Other indications include treatment of patients with metastatic or unresectable local advanced gastrointestinal stromal tumor (GIST) who have been treated with imatinib (product name: Gleevec) and sunitinib (Sutene) and treatment of patients with hepatocellular carcinoma who have been treated with sorafenib (Nexavar).
The ministry advised the pharmaceutical industry to submit an opinion about the upcoming changes in approval condition for Stivarga and backup data by April 17.
Physicians have evaluated Stivarga as potent in liver cancer treatment since the medicine arrived in Korea. Last year, a real-world study confirming the drug’s effectiveness and safety on Koreans was revealed at the Asia session of the European Society for Medical Oncology.
More than 51 percent of Korean patients with hepatocellular carcinoma treated with Stivarga after their Nexavar therapy had a two-year overall survival (OS).
The result was almost the same as the RESORCE trial on 573 patients in 21 countries. According to the study, the median of the total OS of patients who used Stivarga after Nexavar treatment was 26 months.
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