ONXX-STIVARGA was also once recalled by FDA-Blackbox warning label then approved now $2Billion Mkt
The Stivarga label will include a warning that severe and fatal liver toxicity occurred in some patients treated with the medicine during clinical studies, the FDA said.
The approval in Japan was supported by phase 3 data from the CORRECT study, which demonstrated a statistically significant 29 percent improvement in overall survival (OS) in mCRC patients treated with Stivarga following prior failure of approved agents.
Big problem with Omontys is that it is not needed in the marketplace. CKD anemia patients' needs are adequately met by industry standard Epogen/Aranesp with proven safety profiles. Omontys is effective, but it is not safe so it will never return to market.