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FDA Approved Drugs » 2006
Medical Areas: Oncology
View By:Year | Company | Conditions | Therapeutic Areas | Drug Names
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved January 2006
Treatment Area: Kidney Cancer/Gastrointestinal Stromal Tumors
Sutent is an orally-available small-molecule multiple receptor
tyrosine kinase inhibitor. Receptor tyrosine kinases are implicated
in a number of cell-cell signaling pathways governing angiogenesis,
cell division and growth, and cell survival. By disrupting these
systems, Sutent inhibits the ability of tumor cells to divide and
Sutent is specifically indicated for the treatment of a pair on
oncology indications: gastrointestinal stromal tumors (GIST) that
are refractory to or have relapsed following treatment with
imatinib; and advanced renal cell carcinoma (RCC).
Sutent is supplied as a hard gelatin capsule for oral
administration. The recommended initial dose regimen is 50 mg once
daily for 4 weeks, followed by 2 weeks off treatment. Dose may be
adjusted up or down in 12.5 mg increments, based on patient
response and tolerability.
FDA Approval: GIST
Approval of Sutent for the treatment of GIST was based on two
studies, dubbed Study A and Study B.
This two-arm, international, randomized, double-blind,
placebo-controlled study enrolled 312 patients, who received either
50 mg Sutent (n=207) or placebo (n=105) once daily for 4 weeks,
followed by 2 weeks off, until evidence of disease progression was
observed. Sutent was shown to significantly increase median time to
tumor progression, to 27.3 weeks, vs. 6.4 weeks for placebo
(p<0.0001). Secondary efficacy was also established, with the
drug producing progression free survival (24.1 weeks, vs. 6.0
weeks; p<0.0001) and an objective response rate (6.8% vs. 0%;
p=0.006) superior to placebo.
This open-label, multi-center, single-arm, dose-escalation study
was designed to investigate the objective tumor response rate for
Sutent therapy. The trial enrolled 55 subjects, who received 50 mg
Sutent once daily on the 4-weeks on/2-weeks off schedule. Trial
data yielded confirmed partial responses in 5 subjects, a 9.1%
objective response rate.
FDA Approval: RCC
Approval of single-agent Sutent for the treatment of RCC was based
on a pair of single-arm, multi-center studies.
This trial enrolled 106 patients who had failed prior cytokine
therapy (as defined by radiographic evidence of disease progression
(RECIST or WHO criteria) within 9 months of completion of a
cytokine regimen). The trial was designed to investigate the
objective response rate of Sutent therapy. Subjects received daily
doses of 50 mg Sutent on the 4-weeks-on/2-weeks-off schedule until
evidence of disease progression or eligibility for withdrawal was
met. Sutent was shown to produce objective tumor responses (Partial
responses) in 25.5% of subjects (n=27), with a median duration of
response to date of 27.1 weeks (these data were immature at the
time of approval, as 41.5% of subjects remained on protocol without
evidence of progression to date).
Study 2 utilized a similar design to trial 1, treating 63 RCC
patients failing cytokine therapy (as defined by evidence of
disease progression or unacceptable treatment-related toxicity) on
the 50 mg, 4/2 regimen. This study was also designed to investigate
objective response rate and duration of response. In this study,
Sutent produced partial tumor responses in 36.5% of subjects
(n=23), with a median response duration of 54 weeks. At the time of
approval, 11 patients remained on protocol, with ongoing disease
Ongoing Study Commitments
Adverse events associated with the use of Sutent for the
treatment of GIST may include, but are not limited to, the
Adverse events associated with the use of Sutent for the
treatment of RCC may include, but are not limited to, the
Significant incidence of serious (Grade 3/4) hematological
abnormalities (including neutropenia, anemia, lymphopenia,
thrombocytopenia and leukopenia) was observed. Patients should work
in close concert with their physicians to manage these effects.
In addition, Sutent has been associated with reductions in
left-ventricular ejection fraction, including some falls to levels
below the lower limit of normal. Use of Sutent in patients with
cardiac conditions, including congestive heart failure (CHF),
should be pursued only in close consultation with patients'
physicians, and it is recommended that treatment be discontinued in
patients who manifest CHF symptoms while on Sutent therapy.
Sutent is designed to inhibit multiple receptor tyrosine
kinases, including platelet-derived growth factor receptors
(PDGFR-alpha and PDGFR-beta), 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). A number of these kinases have
been implicated in tumor growth, pathologic angiogenesis, and
Motzer RJ, Michaelson MD, Redman BG, Hudes GR, Wilding
G, Figlin RA, Ginsberg MS, Kim ST, Baum CM, DePrimo SE, Li JZ,
Bello CL, Theuer CP, George DJ, Rini BI Activity of
SU11248, a multitargeted inhibitor of vascular endothelial growth
factor receptor and platelet-derived growth factor receptor, in
patients with metastatic renal cell carcinoma. Journal of
Clinical Oncology 2006 Jan 1;24(1):16-24. Epub 2005 Dec 5
Faivre S, Delbaldo C, Vera K, Robert C, Lozahic S,
Lassau N, Bello C, Deprimo S, Brega N, Massimini G, Armand JP,
Scigalla P, Raymond E Safety, pharmacokinetic, and
antitumor activity of SU11248, a novel oral multitarget tyrosine
kinase inhibitor, in patients with cancer. Journal of Clinical
Oncology 2006 Jan 1;24(1):25-35. Epub 2005 Nov 28
Marzola P, Degrassi A, Calderan L, Farace P, Nicolato E,
Crescimanno C, Sandri M, Giusti A, Pesenti E, Terron A, Sbarbati A,
Osculati F Early antiangiogenic activity of SU11248
evaluated in vivo by dynamic contrast-enhanced magnetic resonance
imaging in an experimental model of colon carcinoma. Clinical
Cancer Research 2005 Aug 15;11(16):5827-32
Osusky KL, Hallahan DE, Fu A, Ye F, Shyr Y, Geng
L The receptor tyrosine kinase inhibitor SU11248 impedes
endothelial cell migration, tubule formation, and blood vessel
formation in vivo, but has little effect on existing tumor vessels.
For additional information regarding Sutent, Gastrointestinal
Stromal Tumors or Renal Cell Carcinoma, please visit the
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