WARNING: HEMORRHAGE, GASTROINTESTINAL PERFORATION, COMPROMISED WOUND HEALING
Hemorrhage: Severe and sometimes fatal hemorrhage, including gastrointestinal (GI) hemorrhage, has been reported in the patients who have received ZALTRAP in combination with FOLFIRI. Monitor patients for signs and symptoms of GI bleeding and other severe bleeding. Do not administer ZALTRAP to patients with severe hemorrhage [ see Dosage and Administration, Warnings and Precautions
].
Gastrointestinal Perforation: Gastrointestinal (GI) perforation including fatal GI perforation can occur in patients receiving ZALTRAP. Discontinue ZALTRAP therapy in patients who experience GI perforation [ see Dosage and Administration, Warnings and Precautions
].
Compromised Wound Healing: Severe compromised wound healing can occur in patients receiving ZALTRAP/FOLFIRI. Discontinue ZALTRAP in patients with compromised wound healing. Suspend ZALTRAP for at least 4 weeks prior to elective surgery, and do not resume ZALTRAP for at least 4 weeks following major surgery and until the surgical wound is fully healed [ see Dosage and Administration, Warnings and Precautions
].
|
ZALTRAP SUMMARY
Ziv-aflibercept is a recombinant fusion protein consisting of Vascular Endothelial Growth Factor (VEGF)-binding portions from the extracellular domains of human VEGF Receptors 1 and 2 fused to the Fc portion of the human IgG1. Ziv-aflibercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) K-1 mammalian expression system. Ziv-aflibercept is a dimeric glycoprotein with a protein molecular weight of 97 kilodaltons (kDa) and contains glycosylation, constituting an additional 15% of the total molecular mass, resulting in a total molecular weight of 115 kDa.
ZALTRAP, in combination with 5-fluorouracil, leucovorin, irinotecan-(FOLFIRI), is indicated for patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen [see Clinical Studies].
|
NEWS HIGHLIGHTS
Published Studies Related to Zaltrap (Aflibercept)
Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration. [2012]
Bayer HealthCare, Berlin, Germany) with monthly ranibizumab... CONCLUSIONS: Intravitreal aflibercept dosed monthly or every 2 months after 3
Aflibercept for the treatment of neovascular age-related macular degeneration. [2012]
Age-related macular degeneration (AMD) can have devastating effects on vision,
especially in its neovascular form. In the last decade, the use of intravitreal
pharmacotherapy targeted to vascular endothelial growth factor (VEGF) has
significantly improved the visual outcomes in patients with neovascular AMD...
Clinical Trials Related to Zaltrap (Aflibercept)
Intravitreal Aflibercept Injection for Radiation Retinopathy [Recruiting]
The purpose of this study is to assess the safety of intravitreal aflibercept injection - in
the treatment of macular edema associated with retinopathy secondary to previous radiation
therapy.
REGN910 (SAR307746) and Aflibercept ("Ziv-aflibercept" in the U.S.) in Patients With Advanced Solid Malignancies [Recruiting]
This is an open-label, multicenter, ascending, multiple dose study of REGN910 (SAR307746) in
combination with aflibercept ("ziv-aflibercept" in the U. S.)
Aflibercept and FOLFOX6 Treatment for Previously Untreated Stage IV Colorectal Cancer [Recruiting]
This phase II trial studies how well giving aflibercept together with combination
chemotherapy works in treating patients with previously untreated colon or rectal cancer
that is metastatic or locally advanced and cannot be removed by surgery. Aflibercept may
stop the growth of colon or rectal cancer by blocking blood flow to the tumor. Drugs used in
chemotherapy, such as leucovorin calcium, fluorouracil, and oxaliplatin, work in different
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Giving aflibercept together with combination chemotherapy may kill more tumor
cells
EYLEA Age-Related Macular Degeneration (AMD) Post-marketing Surveillance in Japan [Recruiting]
This study is a regulatory post-marketing surveillance in Japan, and it is a local
prospective and observational study of patients who have received EYLEA for Age-Related
Macular Degeneration (AMD).
The objective of this study is to assess safety and effectiveness of EYLEA using in real
clinical practice.
A total of 4,000 patients are to be enrolled and assessed in 3 years standard observational
period. An annual follow-up survey will be conducted for 5 years at the longest after
standard observational period.
FOLFOX +/- Ziv-Aflibercept for Esophageal and Gastric Cancer [Not yet recruiting]
This research study is a Phase II clinical trial to test the safety and effectiveness of the
investigational drug Ziv-aflibercept in combination with mFOLFOX6 compared to mFOLFOX6
alone. The drugs used in mFOLFOX6 include Fluorouracil (5-FU), Leucovorin and Oxaliplatin.
In patients with esophagogastric cancer, mFOLFOX6 has been used in both clinical trials and
standard of care. "Investigational" means that the FDA has not yet approved this combination
for the treatment of esophagogastric cancer.
Every person has molecules in their bloodstream called vascular endothelial growth factors
(VEGFs). These molecules help grow and sustain new blood vessels needed by the human body.
Cancer tumors hijack this mechanism because they need new blood vessels and oxygen to grow.
Ziv-aflibercept is an antibody, a "targeted therapy" called a "VEGF Trap", that "traps"
(binds) these VEGFs and prevents the cancer from using them to grow. Ziv-aflibercept has
recently been approved by the FDA for patients with treatment-resistant colorectal cancer.
Patients who received standard 5-fluoruracil based chemotherapy pus ziv-aflibercept lived
significantly longer than those patients who received standard 5-fluoruracil alone.
In this research study, investigators will see if adding ziv-aflibercept to standard
chemotherapy (mFOLFOX6) works better than mFOLFOX6 chemotherapy alone in patients with
metastatic or unresectable esophagogastric cancer.
|
