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Association details:
Biomarker:No biomarker
Cancer:Hepatocellular Cancer
Drug:Stivarga (regorafenib) (Multi-tyrosine kinase inhibitor)
Direction:Sensitive
Evidence:
Evidence Level:
Sensitive: A1 - Approval
Title:

Bayer receives approval in China for Stivarga® (regorafenib) for the second-line systemic Treatment of liver cancer

Published date:
12/13/2017
Excerpt:
...Bayer announced today that the Chinese Food and Drug Administration (CFDA) approved Stivarga® (regorafenib) tablets for the second-line treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with Nexavar® (sorafenib).
Evidence Level:
Sensitive: A1 - Approval
Title:

Bayer Receives Approval for Stivarga® in Japan for Second-Line Treatment of Hepatocellular Carcinoma

Published date:
06/26/2017
Excerpt:
...Bayer announced today that the Ministry of Health, Labour and Welfare (MHLW) in Japan has granted marketing authorization for Stivarga® (regorafenib) tablets for the second-line treatment of patients with unresectable hepatocellular carcinoma (HCC) who have progressed after treatment with cancer chemotherapy. 
Evidence Level:
Sensitive: A1 - Approval
Published date:
08/26/2013
Excerpt:
Stivarga is indicated as monotherapy for the treatment of adult patients with:...hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
Evidence Level:
Sensitive: A1 - Approval
Source:
Published date:
09/27/2012
Excerpt:
STIVARGA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
Evidence Level:
Sensitive: A2 - Guideline
Source:
Title:

Systemic Therapy for Advanced Hepatocellular Carcinoma: ASCO Guideline

Published date:
11/16/2020
Excerpt:
Recommendations...First-Line Therapy...Where there are contraindications to atezolizumab and/or bevacizumab, tyrosine kinase inhibitors (TKIs) sorafenib or lenvatinib may be offered as first-line treatment of patients with advanced HCC…Second-Line Therapy...second-line therapy with a TKI (ie, sorafenib, lenvatinib, cabozantinib, or regorafenib) may be recommended...second-line therapy with another TKI (cabozantinib or regorafenib), ramucirumab (AFP ≥ 400 ng/mL)...
DOI:
0.1200/JCO.20.02672 Journal of Clinical Oncology
Evidence Level:
Sensitive: A2 - Guideline
New
Source:
Title:

Hepatocellular carcinoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up

Excerpt:
Management of advanced disease...Regorafenib is the standard of care for patients with advanced HCC who have tolerated sorafenib but progressed. It is recommended in patients with well-preserved liver function and ECOG PS 0–1 [I, A]
DOI:
10.1093/annonc/mdy308
Evidence Level:
Sensitive: A2 - Guideline
New
Source:
Excerpt:
The panel now recommends several subsequent-line therapy options for patients with disease progression following systemic therapy. Category 1 options include regorafenib, cabozantinib, and ramucirumab. Regorafenib and cabozantinib are recommended only for patients with C-P A liver function, while ramucirumab is recommended only for patients with a baseline AFP level of 400 ng/mL or greater.
Evidence Level:
Sensitive: B - Late Trials
New
Source:
Title:

Regorafenib for patients with hepatocellular carcinoma who progressed on sorafenib treatment (RESORCE): a randomised, double-blind, placebo-controlled, phase 3 trial

Excerpt:
Regorafenib improved overall survival with a hazard ratio of 0·63 (95% CI 0·50–0·79; one-sided p<0·0001); median survival was 10·6 months (95% CI 9·1–12·1) for regorafenib versus 7·8 months (6·3–8·8) for placebo….Regorafenib is the only systemic treatment shown to provide survival benefit in HCC patients progressing on sorafenib treatment.
DOI:
https://doi.org/10.1016/S0140-6736(16)32453-9
Trial ID: