Sorafenib (Nexavar) is an oral multikinase inhibitor approved by the U.S. Food and Drug Administration for the treatment of patients with advanced renal cell carcinoma (RCC) and those with unresectable hepatocellular carcinoma (HCC). While the U.S. Food and Drug Administration (FDA) has approved the multikinase inhibitors sorafenib ( Nexavar
®; Bayer) in first line treatment and regorafenib Stivarga ®; Bayer) in second-line treatment of HCC, these agents have been shown to extend overall survival by fewer than 3 months with. A study at The University of Texas MD Anderson Cancer Center , funded, in part, by the National Institutes of Health (NIH) discovered a cellular pathway tied to cancer that may be beneficial in reducing side effects and extending duration of immunotherapy in some patients with hepatocellular carcinoma (HCC), a tumor of the parenchymal cells of the liver.1.
Bayer has announced that National Institute for Health and Care Excellence (NICE) has recommended Stivarga® (regorafenib) as an option for treating advanced unresectable HCC in adults who have had Nexavar® (sorafenib) only if patients have Child-Pugh grade A liver impairment and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 1 We conducted a phase 3 study, the Treatment Approaches in Renal Cancer Global Evaluation Trial (TARGET), to determine the effects of sorafenib on progression-free survival and overall survival in patients with advanced clear-cell renal-cell carcinoma in whom one previous systemic therapy had failed. Results from this large phase 3 trial demonstrate the potential of Lenvima to improve the outcomes of liver cancer patients, and provide an overall survival benefit that is non-inferior to Nexavar, currently the only systemic therapy approved by the European Medicines Agency for unresectable HCC,” Jeff Evans, MD, FRCP, from the University of Glasgow, said in a press release.
Indian pharma major Cipla's announcement that it has decided to slash the price of generic version of Bayer's cancer drug Nexavar to treat certain types of kidney and liver cancers from around Rs 28,000 to Rs 6,840 for a monthly dose is seen as a price war in the cancer treatment. The only included study that provided mean and standard deviation values reported that patients treated with sorafenib had lower PPPM costs than sunitinib as first-line treatment for mRCC ($6,990.36 ± 3,073.11 vs. $7,944.91 ± 2,993.36) ( 23 ). In a retrospective claims database analysis, Duh et al. found that the mean medical costs of sorafenib were less than that of sunitinib in the treatment of aRCC ($6,998 and $8,213, respectively) ( 29 ). Similarly, in an analysis of 18 American community oncology clinics, Chen et al. reported that sunitinib was associated with higher PPPM costs than sorafenib ($9,417.35 ± 670.78 vs. $7,992.48 ± 682.29) ( 30 ). Although the costs of the two drugs were not greatly different, sorafenib therapy might help relieve the financial pressure on patients and their families to some extent, extend the time of using TKIs while providing equivalent treatment efficacy as sunitinib, and even relieve the psychological burden of patients facing high medical expenses, especially for patients from low-income families or developing countries. In addition, the SOFIA study (Sorafenib Italian Assessment) (45) found that full-dose Sorafenib was not cost-effective compared with BSC for patients with the intermediate or advanced stages of HCC.... The results show that Sorafenib costeffective within their societal willing-to-pay thresholds (26,27) A study of cost-effectiveness analysis of real world data acquired from the SEER-Medicare database.
Until recently, the only FDA approved first line drug for patients with advanced HCC (stage C according to BCLC classification) is the multi-kinase inhibitor sorafenib 4 Unfortunately, large trials have shown only a minimal benefit with sorafenib, translated to a median survival and time to progression benefit of less than three months, at the cost of potentially serious side effects 5 , 6 Therefore, until more effective and safe therapies for patients with advanced HCC are made available, one should cautiously consider the benefit of this treatment on an individual basis, especially in patients with more advanced liver disease 7. In a retrospective study reported in the Journal of Clinical Oncology , Reiss et al found that reducing the starting dose of sorafenib (Nexavar) was associated with noninferior overall survival, reduced cost, and lower risk of discontinuing treatment in patients with advanced hepatocellular carcinoma. Hepatocellular carcinoma is the most common type of liver cancer in adults, and while we have seen recent therapeutic advancements, there are still limited treatment options for advanced recurrent disease,” Andrew X. Zhu, MD, PhD, lead investigator and director of liver cancer research at Massachusetts General Hospital and professor of medicine at Harvard Medical School, said in a statement.
In the palliative substudy, which was presented at the International Liver Congress, 424 patients with inoperable hepatocellular carcinoma (HCC) who were not candidates for transarterial chemoembolization (TACE) were randomized to receive treatment with either SIRT with yttrium-90 resin microspheres (SIR-Spheres, Sirtex Medical Inc.) plus sorafenib (target dose 400 mg twice daily) or sorafenib alone.