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Avastin – Newly FDA Approved Drug for Treating Cervical Cancer
- Updated: August 16, 2014
For years, focus has been on developing an effective drug for treating cervical cancer and recently, the Food and Drug Administration (FDA) announced success. Classified as an angiogenesis inhibitor called bevacizumab or formally, Avastin, this is not a standalone drug but one used in combination with chemotherapy. Even so, in-depth clinical studies offer promising results.
Bevacizumab was initially marketed in 2004 specifically for treating metastatic colorectal cancer but eventually, approval was expanded with the drug becoming a priority therapy for different stages of glioblastoma, metastatic renal-cell carcinoma, and non-small cell lung cancer. Although used for recurrent and platinum-resistant ovarian cancer and advanced breast cancer outside the United States, bevacizumab finally received FDA approval in 2008 for metastatic breast cancer. Unfortunately, after the FDA reviewed all submitted data, it felt that risks outweighed benefits and therefore, approval was revoked in 2011.
However, data from a study involving 452 patients with varying stages of cervical cancer to include persistent, recurrent, and late-stage was carefully reviewed by the FDA. As part of the trial, participants were randomly given bevacizumab with and without paclitaxel-cisplatin chemotherapy.
The survival rate for those in the group that included bevacizumab was 16.8 months compared to 12.9 months for those not administered the new drug. Thanks to this new review, the drug Avastin was recently given the nod of approval from the FDA.
Under the FDA’s priority review program, a special status is used to speed up the process of therapies shown to offer improvement over other current therapies. Using this granting status, action was taken to approve the use of bevacizumab as a cancer treatment when given in conjunction with paclitaxel plus topotecan or paclitaxel plus cisplatin.
Although topotecan with cisplatin has been used to treat cervical cancer since 2006, bevacizumab is the first drug approved since. It is also the first biologic agent used for treating cancer of this type under the priority review program, thereby allowing the FDA to grant approval in less than four months.
As with other FDA approved drugs, there are side effects of bevacizumab to include decreased appetite, hyperglycemia, fatigue, urinary tract infection, high blood pressure, weight loss, hypomagnesemia, and headache. On a lesser scale but reported in some patients is enterovaginal fistulae, which consists of a hole that develops between the vagina and intestine, and gastrointestinal perforation, a problem that causes contents of the intestine to leak into the abdominal cavity.
Even with certain risks, experts agree the approval of bevacizumab is incredible news. This drug works by targeting the vascular endothelial growth factor (VEGF) angiogenesis stimulating protein. Because of this finding, the cervical cancer indication is just one on a growing list of potential approvals. Clinical research is currently underway to determine the effects of bevacizumab on ovarian cancer, as well as advanced stage breast cancer.
Along with this, researchers are looking into the benefits but also risks of bevacizumab as it relates to liver cancer, neuroblastoma, melanoma, and rectal cancer. Studies are also being conducted for the different types of cancer that bevacizumab has already been approved for as a means of determining any expanded indications.