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FDA approves Avastin to treat patients with aggressive and late-stage cervical cancer
August 14, 2014
The U.S. Food and Drug Administration today approved a new use for Avastin (bevacizumab) to treat patients with persistent, recurrent or late-stage (metastatic) cervical cancer.
Cervical cancer grows in the tissues of the lower part of the uterus known as the cervix. It commonly occurs when human papillomaviruses (HPV), a virus that spreads through sexual contact, cause cells to become cancerous. Although there are two licensed vaccines available to prevent many types of HPV that can cause cervical cancer, the National Cancer Institute estimates that 12,360 American women will be diagnosed with cervical cancer and 4,020 will die from the disease in 2014.
Avastin works by interfering with the blood vessels that fuel the development of cancerous cells. The new indication for cervical cancer is approved for use in combination with chemotherapy drugs paclitaxel and cisplatin or in combination with paclitaxel and topotecan.
“Avastin is the first drug approved for patients with late-stage cervical cancer since the 2006 approval of topotecan with cisplatin,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “It is also the first biologic agent approved for patients with late-stage cervical cancer and was approved in less than four months under the FDA’s priority review program, demonstrating the agency’s commitment to making promising therapies available to patients faster.”
The FDA reviewed Avastin for treatment of patients with cervical cancer under its priority review program because the drug demonstrated the potential to be a significant improvement in safety or effectiveness over available therapy in the treatment of a serious condition. Priority review provides an expedited review of a drug’s application.
The safety and effectiveness of Avastin for treatment of patients with cervical cancer was evaluated in a clinical study involving 452 participants with persistent, recurrent, or late-stage disease. Participants were randomly assigned to receive paclitaxel and cisplatin with or without Avastin or paclitaxel and topotecan with or without Avastin. Results showed an increase in overall survival to 16.8 months in participants who received chemotherapy in combination with Avastin as compared to 12.9 months for those receiving chemotherapy alone.
The most common side effects associated with use of Avastin in patients with cervical cancer include fatigue, decreased appetite, high blood pressure (hypertension), increased glucose in the blood (hyperglycemia), decreased magnesium in the blood (hypomagnesemia), urinary tract infection, headache and decreased weight. Perforations of the gastrointestinal tract and abnormal openings between the gastrointestinal tract and vagina (enterovaginal fistula) also were observed in Avastin-treated patients.
Avastin is marketed by South San Francisco, California-based Genentech, a member of the Roche Group.
| Country | Patent Number | Approved | Expires (estimated) |
|---|---|---|---|
| Canada | 2286330 | 2008-06-10 | 2018-04-03 |
| Canada | 2145985 | 2003-09-16 | 2012-10-28 |
| Property | Value | Source |
|---|---|---|
| melting point | 61 °C (FAB fragment), 71 °C (whole mAb) | Vermeer, A.W.P. & Norde, W., Biophys. J. 78:394-404 (2000) |
| Protein chemical formula | C6538H10034N1716O2033S44 |
|---|---|
| Protein average weight | 149 kDa |
A recombinant humanized monoclonal IgG1 antibody that binds to and inhibits the biologic activity of human vascular endothelial growth factor (VEGF). Bevacizumab contains human framework regions and the complementarity-determining regions of a murine antibody that binds to VEGF. Bevacizumab is produced in a Chinese Hamster Ovary mammalian cell expression system in a nutrient medium containing the antibiotic gentamicin and has a molecular weight of approximately 149 kilodaltons.
sequence
>"Bevacizumab light chain" DIQMTQSPSSLSASVGDRVTITCSASQDISNYLNWYQQKPGKAPKVLIYFTSSLHSGVPS RFSGSGSGTDFTLTISSLQPEDFATYYCQQYSTVPWTFGQGTKVEIKRTVAAPSVFIFPP SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
>"Bevacizumab heavy chain" EVQLVESGGGLVQPGGSLRLSCAASGYTFTNYGMNWVRQAPGKGLEWVGWINTYTGEPTY AADFKRRFTFSLDTSKSTAYLQMNSLRAEDTAVYYCAKYPHYYGSSHWYFDVWGQGTLVT VSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVL QSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPEL LGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREE QYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPS REEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDK SRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized (from mouse) |
| Target | VEGF-A |
| Clinical data | |
| Trade names | Avastin |
| AHFS/Drugs.com | monograph |
| Licence data | EMA:Link, US FDA:link |
| Pregnancy cat. | C (US) |
| Legal status | ℞ Prescription only |
| Routes | Intravenous |
| Pharmacokinetic data | |
| Bioavailability | 100% (IV only) |
| Half-life | 20 days (range: 11–50 days) |
| Identifiers | |
| CAS number | 216974-75-3  |
| ATC code | L01XC07 |
| DrugBank | DB00112 |
| UNII | 2S9ZZM9Q9V |
| KEGG | D06409 |
| ChEMBL | CHEMBL1201583  |
| Chemical data | |
| Formula | C6638H10160N1720O2108S44 |
| Mol. mass | approx. 149 kDa |
FDA has approved a new use of Avastin® (bevacizumab) in combination with fluoropyrimidine-based irinotecan or oxaliplatin chemotherapy for people with metastatic colorectal cancer (mCRC).
Bevacizumab, CAS NO 216974-75-3
A MONOCLONAL ANTIBODY
January 23, 2013
Avastin (bevacizumab) is a recombinant humanized monoclonal IgG1 antibody that binds to and inhibits the biologic activity of human vascular endothelial growth factor (VEGF) in in vitro and in vivo assay systems. Bevacizumab contains human framework regions and the complementarity-determining regions of a murine antibody that binds to VEGF. Avastin has an approximate molecular weight of 149 kD. Bevacizumab is produced in a mammalian cell (Chinese Hamster Ovary) expression system in a nutrient medium containing the antibiotic gentamicin. Gentamicin is not detectable in the final product.
FDA has approved a new use of Avastin® (bevacizumab) in combination with fluoropyrimidine-based irinotecan or oxaliplatin chemotherapy for people with metastatic colorectal cancer (mCRC).
On January 23, 2013, the FDA has approved a new use of Avastin® (bevacizumab) in combination with fluoropyrimidine-based irinotecan or oxaliplatin chemotherapy for people with metastatic colorectal cancer (mCRC). The new indication will allow people who received Avastin plus an irinotecan or oxaliplatin containing chemotherapy as an initial treatment (first-line) for mCRC to continue to receive Avastin plus a different irinotecan or oxaliplatin containing chemotherapy after their cancer worsens (second-line treatment).
People who start on Avastin for mCRC can now stay on Avastin after their cancer worsens.
Bevacizumab (trade name Avastin, Genentech/Roche) is an angiogenesis inhibitor, a drug that slows the growth of new blood vessels. It is licensed to treat various cancers, including colorectal, lung, breast (outside the USA), glioblastoma (USA only), kidney and ovarian.
Bevacizumab is a humanized monoclonal antibody that inhibits vascular endothelial growth factor A (VEGF-A).[1] VEGF-A is a chemical signal that stimulates angiogenesis in a variety of diseases, especially in cancer. Bevacizumab was the first clinically available angiogenesis inhibitor in the United States.[citation needed]
Bevacizumab was approved by the U.S. Food and Drug Administration (FDA) for certain metastatic cancers. It received its first approval in 2004, for combination use with standard chemotherapy for metastatic colon cancer.[2] It has since been approved for use in certain lung cancers, renal cancers, and glioblastoma multiforme of the brain.
At one point bevacizumab was approved for breast cancer by the FDA, but the approval was revoked on 18 November 2011.[3][4]
- Los, M.; Roodhart, J. M. L.; Voest, E. E. (2007). “Target Practice: Lessons from Phase III Trials with Bevacizumab and Vatalanib in the Treatment of Advanced Colorectal Cancer”. The Oncologist 12 (4): 443–50. doi:10.1634/theoncologist.12-4-443. PMID 17470687.
- http://www.gene.com/gene/products/information/pdf/avastin-prescribing.pdf
- Pollack, Andrew (18 November 2011). “F.D.A. Revokes Approval of Avastin for Breast Cancer”. New York Times.
- “Cancer drug Avastin loses US approval”. BBC. November 18, 2011.
SEQUENCE
>1bj1_H|Fab-12, F(ab)-12, 12-IgG1, rhuMAb-VEGF|||VH-CH1 (VH(1-123)+CH1(124-215))|||||||231||||MW 24867.8|MW 24867.8| EVQLVESGGGLVQPGGSLRLSCAASGYTFTNYGMNWVRQAPGKGLEWVGWINTYTGEPTY AADFKRRFTFSLDTSKSTAYLQMNSLRAEDTAVYYCAKYPHYYGSSHWYFDVWGQGTLVT VSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVL QSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHT >1bj1_L|Fab-12, F(ab)-12, 12-IgG1, rhuMAb-VEGF|||L-KAPPA (V-KAPPA(1-107)+C-KAPPA(108-213))|||||||214||||MW 23451.0|MW 23451.0| DIQMTQSPSSLSASVGDRVTITCSASQDISNYLNWYQQKPGKAPKVLIYFTSSLHSGVPS RFSGSGSGTDFTLTISSLQPEDFATYYCQQYSTVPWTFGQGTKVEIKRTVAAPSVFIFPP SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC >1bj1_J|Fab-12, F(ab)-12, 12-IgG1, rhuMAb-VEGF|||L-KAPPA (V-KAPPA(1-107)+C-KAPPA(108-213))|||||||214||||MW 23451.0|MW 23451.0| DIQMTQSPSSLSASVGDRVTITCSASQDISNYLNWYQQKPGKAPKVLIYFTSSLHSGVPS RFSGSGSGTDFTLTISSLQPEDFATYYCQQYSTVPWTFGQGTKVEIKRTVAAPSVFIFPP SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC >1bj1_K|Fab-12, F(ab)-12, 12-IgG1, rhuMAb-VEGF|||VH-CH1 (VH(1-123)+CH1(124-215))|||||||231||||MW 24867.8|MW 24867.8| EVQLVESGGGLVQPGGSLRLSCAASGYTFTNYGMNWVRQAPGKGLEWVGWINTYTGEPTY AADFKRRFTFSLDTSKSTAYLQMNSLRAEDTAVYYCAKYPHYYGSSHWYFDVWGQGTLVT VSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVL QSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHT
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