BAYER HLTHCARE — Stivarga FDA Review (NDA/BLA 203085, 2019)
Bayer Aktiengesellschaft · 2019 · FDA Review (Drugs@FDA) · company profile →
Report summary
The FDA approved Stivarga (regorafenib) for hepatocellular carcinoma (HCC) in patients previously treated with sorafenib, based on the RESORCE (Study 15982) trial. This supplemental new drug application (sNDA) builds on existing approvals for metastatic colorectal cancer (CRC) and gastrointestinal stromal tumor (GIST). The RESORCE trial demonstrated significant improvements in overall survival and progression-free survival for regorafenib compared to placebo, addressing an unmet medical need. The safety profile was consistent with previous approvals, with common adverse reactions including hand-foot skin reactions, infection, and hemorrhage. The recommended dosage is 160 mg daily for 21 days on/7 days off. The review also confirmed the consistency of efficacy across subgroups and an acceptable toxicity profile.
Key findings — cited to the page
| incidence of >=Grade 3 infection | 9 % | · p.48 |
| incidence of >=Grade 3 hand-foot skin reaction (HFSR) | 16 % | · p.48 |
| Grade 3+ infection | 9 % | · p.40 |
| Grade 3+ hemorrhage | 3 % | · p.40 |
| incidence of Grade 3 hypertension in younger patients | 9 % | STIVARGA · p.58 |
| incidence of >=Grade 3 hemorrhage | 3 % | · p.48 |
| Grade 4 hypertension events in patients >= 65 years | 1 | · p.58 |
| Grade 3+ hand-foot skin reaction (HFSR) | 16 % | · p.40 |
| Pyrexia (all grades, placebo) | 7 % | Study 15982 · p.102 |
| Grade 4 hypertension events in younger patients | 0 | · p.58 |
| incidence of Grade 3 hypertension in patients >= 65 years | 18 % | STIVARGA · p.58 |
| incidence of >=Grade 3 rash | 3 % | · p.48 |
Source: Bayer Aktiengesellschaft ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →