Difference between revisions of "Regorafenib (Stivarga)"
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| − | '''FDA approved 9/27/2012''' | + | '''FDA approved 9/27/2012'''. |
==General information== | ==General information== | ||
| − | Class/mechanism: Small molecule inhibitor of multiple tyrosine kinases, such as: VEGFR1, VEGFR2, VEGFR3, KIT, RET, PDGFR-alpha, PDGFR-beta, FGFR1, FGFR2, TIE2, DDR2, Trk2A, Eph2A, RAF-1, BRAF, BRAFV600E, SAPK2, PTK5, and Abl | + | Class/mechanism: Small molecule inhibitor of multiple tyrosine kinases, such as: VEGFR1, VEGFR2, VEGFR3, KIT, RET, PDGFR-alpha, PDGFR-beta, FGFR1, FGFR2, TIE2, DDR2, Trk2A, Eph2A, RAF-1, BRAF, BRAFV600E, SAPK2, PTK5, and Abl, which are involved in tumor cell proliferation, survival, and angiogenesis. Its major active metabolites are M-2 and M-5.<ref name="insert">[http://labeling.bayerhealthcare.com/html/products/pi/Stivarga_PI.pdf Regorafenib (Stivarga) package insert]</ref><ref>[[Media:Regorafenib.pdf | Regorafenib (Stivarga) package insert (locally hosted backup)]]</ref><ref>[http://www.stivarga.com Stivarga manufacturer's website]</ref> |
<br>Route: PO | <br>Route: PO | ||
<br>Extravasation: n/a | <br>Extravasation: n/a | ||
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==Diseases for which it is used== | ==Diseases for which it is used== | ||
*[[Colon cancer]] | *[[Colon cancer]] | ||
| + | *[[Sarcoma|GIST (Gastrointestinal Stromal Tumor)]] | ||
==Clinical trials== | ==Clinical trials== | ||
| Line 17: | Line 18: | ||
==Patient drug information== | ==Patient drug information== | ||
| − | *[http://labeling.bayerhealthcare.com/html/products/pi/Stivarga_PI.pdf#page= | + | *[http://labeling.bayerhealthcare.com/html/products/pi/Stivarga_PI.pdf#page=19 Regorafenib (Stivarga) package insert PDF pages 19-23]<ref name="insert"></ref> |
| + | *[http://www.chemocare.com/chemotherapy/drug-info/regorafenib.aspx Regorafenib (Stivarga) patient drug information (Chemocare)]<ref>[http://www.chemocare.com/chemotherapy/drug-info/regorafenib.aspx Regorafenib (Stivarga) patient drug information (Chemocare)]</ref> | ||
| + | *[http://www.uptodate.com/contents/regorafenib-patient-drug-information Regorafenib (Stivarga) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/regorafenib-patient-drug-information Regorafenib (Stivarga) patient drug information (UpToDate)]</ref> | ||
| + | |||
| + | ==History of changes in FDA indication== | ||
| + | *9/27/2012: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm321378.htm FDA approved] for "patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy." | ||
| + | *2/25/2013: [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm340958.htm FDA approved] for "patients with advanced gastrointestinal stromal tumors (GIST) that cannot be surgically removed and no longer respond to other FDA-approved treatments for this disease." | ||
| + | |||
| + | ==Also known as== | ||
| + | BAY 73-4506. | ||
==References== | ==References== | ||
<references/> | <references/> | ||
| + | |||
| + | [[Category:Drug index]] | ||
| + | [[Category:Chemotherapy]] | ||
| + | [[Category:Tyrosine kinase inhibitors]] | ||
| + | [[Category:Colon cancer medications]] | ||
| + | [[Category:Sarcoma medications]] | ||
| + | [[Category:Drugs FDA approved in 2012]] | ||
Revision as of 16:24, 3 April 2013
FDA approved 9/27/2012.
General information
Class/mechanism: Small molecule inhibitor of multiple tyrosine kinases, such as: VEGFR1, VEGFR2, VEGFR3, KIT, RET, PDGFR-alpha, PDGFR-beta, FGFR1, FGFR2, TIE2, DDR2, Trk2A, Eph2A, RAF-1, BRAF, BRAFV600E, SAPK2, PTK5, and Abl, which are involved in tumor cell proliferation, survival, and angiogenesis. Its major active metabolites are M-2 and M-5.[1][2][3]
Route: PO
Extravasation: n/a
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the package insert.
Diseases for which it is used
Clinical trials
- CORRECT: A randomized, double-blind, placebo-controlled phase III study of regorafenib plus BSC versus placebo plus BSC in patients with metastatic colorectal cancer (CRC) who have progressed after standard therapy 2012 ASCO Gastrointestinal Cancers Symposium abstract LBA385;[4] Clinicaltrials.gov NCT01103323; Bayer study 14387
- Regorafenib in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor after Failure with Imatinib or Sunitinib;[5] Clinicaltrials.gov NCT01068769
- List of regorafenib clinical trials at Cancer.gov
Patient drug information
- Regorafenib (Stivarga) package insert PDF pages 19-23[1]
- Regorafenib (Stivarga) patient drug information (Chemocare)[6]
- Regorafenib (Stivarga) patient drug information (UpToDate)[7]
History of changes in FDA indication
- 9/27/2012: FDA approved for "patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy."
- 2/25/2013: FDA approved for "patients with advanced gastrointestinal stromal tumors (GIST) that cannot be surgically removed and no longer respond to other FDA-approved treatments for this disease."
Also known as
BAY 73-4506.
References
- ↑ 1.0 1.1 Regorafenib (Stivarga) package insert
- ↑ Regorafenib (Stivarga) package insert (locally hosted backup)
- ↑ Stivarga manufacturer's website
- ↑ Axel Grothey, Alberto F. Sobrero, Salvatore Siena, Alfredo Falcone, Marc Ychou, Heinz-Josef Lenz, Takayuki Yoshino, Frank Cihon, Andrea Wagner, Eric Van Cutsem, on behalf of the CORRECT Study Team. Results of a phase III randomized, double-blind, placebo-controlled, multicenter trial (CORRECT) of regorafenib plus best supportive care (BSC) versus placebo plus BSC in patients (pts) with metastatic colorectal cancer (mCRC) who have progressed after standard therapies. 2012 ASCO Gastrointestinal Cancers Symposium abstract LBA385 link to abstract
- ↑ George S, Wang Q, Heinrich MC, Corless CL, Zhu M, Butrynski JE, Morgan JA, Wagner AJ, Choy E, Tap WD, Yap JT, Van den Abbeele AD, Manola JB, Solomon SM, Fletcher JA, von Mehren M, Demetri GD. Efficacy and safety of regorafenib in patients with metastatic and/or unresectable GI stromal tumor after failure of imatinib and sunitinib: a multicenter phase II trial. J Clin Oncol. 2012 Jul 1;30(19):2401-7. Epub 2012 May 21. link to original article PubMed
- ↑ Regorafenib (Stivarga) patient drug information (Chemocare)
- ↑ Regorafenib (Stivarga) patient drug information (UpToDate)