Sunitinibis a small molecule that inhibits multiple receptor tyrosine kinases, some of which are implicated intumorgrowth, pathologic angiogenesis, and metastatic progression of cancer.Sunitinibwas evaluated for its inhibitory activity against a variety of kinases (>80 kinases) and was identified as an inhibitor of platelet-derived growth factor receptors (PDGFRalpha and PDGFRbeta), vascular endothelial growth factor receptors (VEGFR1, VEGFR2 and VEGFR3), stem cell factor receptor (KIT),Fms-like tyrosine kinase-3 (FLT3), colony stimulating factor receptor Type 1 (CSF-1R), and the glial cell-line derived neurotrophic factor receptor (RET).
SUTENT is indicated in the US for the treatment of gastrointestinal stromaltumor (GIST) after disease progression on or intolerance toimatinibmesylate; the treatment of advanced RCC; the adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy; and the treatment of progressive, well-differentiated pancreatic neuroendocrinetumors(pNET) in patients withunresectablelocally advanced or metastatic disease.
SUTENT Important Safety Information from the US FDA Approved Label
Boxed Warning/Hepatotoxicity has been observed in clinical trials andpostmarketingexperience. Hepatotoxicity may be severe, and in some cases fatal. Monitor hepatic function and interrupt, reduce, or discontinue dosing as recommended. Fatal liver failure has been observed. Monitor liver function tests before initiation of treatment, during each cycle of treatment, and as clinically indicated. Interrupt SUTENT for Grade 3 or 4 drug-related hepatic adverse reactions and discontinue if there is no resolution. Do not restart SUTENT if patients subsequently experience severe changes in liver function tests or have signs and symptoms of liver failure.
Additional warnings and precautions for SUTENT include cardiovascular events, QT prolongation andTorsadesde Pointes, hypertension,hemorrhagicevents,tumorlysis syndrome (TLS), thromboticmicroangiopathy(TMA), proteinuria, dermatologic toxicities including erythemamultiforme, Sevens-Johnson syndrome, and toxic epidermal necrolysis, necrotizing fasciitis, thyroid dysfunction,hypoglycemia, osteonecrosis of the jaw (ONJ), impaired wound healing, embryofetaltoxicity and impaired reproductive potential, potential harm during lactation, venous thromboembolic events, reversible posterior leukoencephalopathy syndrome (RPLS), and pancreatic function.
Common adverse reactions (reported in at least 20% of patients) in patients receiving SUTENT for treatment-nave metastatic RCC werediarrhea, fatigue, nausea, anorexia, altered taste,mucositis/stomatitis, pain in extremity/limb discomfort, vomiting, bleeding, all sites, hypertension, dyspepsia, arthralgia, abdominal pain, rash, hand-foot syndrome, back pain, cough, asthenia,dyspnea, skin discoloration/yellow skin, peripheraledema, headache, constipation, dry skin, fever, and haircolorchanges.
Common adverse reactions (reported in at least 20% of patients) in patients receiving SUTENT for adjuvant treatment of RCC, GIST orpNET- and more commonly than in patients given placebo - weremucositis/stomatitis/oral syndromes,diarrhea, fatigue, asthenia, hand-foot syndrome, hypertension, altered taste, nausea, dyspepsia, abdominal pain, hypothyroidism/TSH increased, rash, haircolorchanges, anorexia, skin discoloration, constipation, vomiting, bleeding events, epistaxis, anddysgeusia.
For more information and full Prescribing Information, visitwww.SUTENT.com [http://www.SUTENT.com ].
About Merck-Pfizer Alliance
Immuno-oncology is a top priority for Merck and Pfizer. The global strategic alliance between Merck and Pfizer enables the companies to benefit from each other's strengths and capabilities and further explore the therapeutic potential of avelumab, an anti-PD-L1 antibody initially discovered and developed by Merck. The immuno-oncology alliance is jointly developing and commercializing avelumab and advancing Pfizer's PD-1 antibody. The alliance is focused on developing high-priority international clinical programs to investigate avelumab as a monotherapy as well as combination regimens, and is striving to find new ways to treat cancer.
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About Merck
Merck, a leading science and technology company, operates across healthcare, life science and performance materials. Around 51,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices - the company is everywhere. In 2017, Merck generated sales of EUR 15.3 billion in 66 countries.
Scientific exploration and responsible entrepreneurship have been key to Merck's technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as EMDSeronoin healthcare, MilliporeSigmain life science, and EMD Performance Materials.
Pfizer Inc.: Working together for a healthierworld(R)
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website atwww.pfizer.com [https://urldefense.proofpoint.com/v2/url?u=http-3A__www.pfiz... ] . In addition, to learn more, please visit us onwww.pfizer.com [https://urldefense.proofpoint.com/v2/url?u=http-3A__www.pfiz... ] and follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
Pfizer Disclosure Notice
The information contained in this release is as of February 11, 2019. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
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