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FDA Approval: Bevacizumab (Avastin) for Colorectal Cancer
FDA approved Bevacizumab (Avastin), an anti-VEGF antibody, for certain people with colorectal cancer. What was approved, the evidence, and what it does and doesn't mean.
Original commentary from the Cancer Explained editorial team.
Historical context: this page explains an event dated 2004. It was published as an explainer on July 12, 2026 and is not breaking news.
Please note: this page is educational only — it is not medical advice, and it does not speculate about anyone’s health beyond reliable public reporting. For questions about your own health, talk with your healthcare team.
What FDA approved, and when
On February 26, 2004, the Food and Drug Administration approved Avastin. That is the brand name for bevacizumab. It was cleared under Biologic License Application 125085, held by Genentech. The indication was narrow: Avastin, used with intravenous chemotherapy based on 5-fluorouracil, for first-line treatment of metastatic cancer of the colon or rectum.
"First-line" means the first drug treatment given after the cancer has spread. It was the first drug of its kind cleared for any cancer.
Starving a tumor of blood supply
A tumor bigger than a few millimeters cannot survive on the blood vessels already around it. It sends out chemical signals that recruit new ones. That process is called angiogenesis.
One of the loudest of those signals is vascular endothelial growth factor, or VEGF. Bevacizumab is a monoclonal antibody, a laboratory-made protein built to grab one target. It binds VEGF in the bloodstream so the signal cannot reach the cells that would build new vessels.
The drug does not attack cancer cells directly. It works on the tissue around them. That is a different idea from most of what came before it, and it explains the pattern of side effects.
The trial behind the approval
Study 1 was randomized, double-blind and active-controlled. Everyone received chemotherapy; the question was what adding bevacizumab did.
People were assigned to one of three arms. The first got bolus-IFL, a regimen of irinotecan, 5-fluorouracil and leucovorin, plus placebo. The second got bolus-IFL plus bevacizumab by infusion every two weeks, dosed by body weight. The third got 5-FU and leucovorin plus bevacizumab. That third arm was closed early, as planned, once the second arm looked tolerable.
The comparison that supported the approval used 411 people on chemotherapy plus placebo and 402 on chemotherapy plus bevacizumab.
What the numbers showed
Median overall survival was 15.6 months with chemotherapy and placebo, and 20.3 months with bevacizumab added. The hazard ratio was 0.66, and the difference was significant at p below 0.001.
Median progression-free survival, the time before the cancer grew again, went from 6.4 months to 10.6 months, hazard ratio 0.54. The proportion of people whose tumors shrank by a defined amount rose from 35 percent to 45 percent. Median duration of response went from 7.1 months to 10.4 months.
Overall survival is the endpoint that matters most, and this trial moved it. That is worth saying plainly, because many approvals rest on softer measures. Our page on clinical trial phases explains what separates those endpoints.
The harms that came with it
The 2004 label led with warnings. Gastrointestinal perforation is a hole in the wall of the bowel. It occurred in 2 percent of people receiving bolus-IFL with bevacizumab. It happened at any point in treatment, not after a set exposure. The label said the usual presentation was abdominal pain with symptoms such as constipation and vomiting. The drug was to be stopped for good if it happened.
Wound healing complications came next: surgical wounds coming apart, sometimes needing intervention. The label noted that the right gap between stopping bevacizumab and elective surgery had not been established. A separate warning covered hemorrhage, specifically serious and sometimes fatal coughing up of blood in people with non-small cell lung cancer.
Raised blood pressure was also more common with bevacizumab in Study 1, and the label gave dosing instructions for it. Blocking VEGF affects normal blood vessels, not only the ones a tumor is building. A drug that works on blood supply cannot be selective about whose blood supply it works on.
Where this sits in colorectal cancer today
The American Cancer Society puts new colorectal cancers in the United States in 2026 at 158,850 and deaths at 55,230; SEER, the federal cancer statistics program, republishes both. It is the fourth most common cancer in the country. About 23 percent are already at a distant stage when found. That is the group this approval addressed.
Five-year relative survival across all stages was 65.4 percent for people diagnosed from 2016 through 2022. That is a group statistic covering every stage, and it does not describe any one person's outlook.
What this does and doesn't change
The approval expanded first-line options for people with metastatic colorectal cancer, and it opened a whole drug class. It did not do the following things:
- It did not apply to earlier-stage colorectal cancer, where the cancer has not spread.
- It did not establish that everyone with metastatic colorectal cancer benefits. The gain in median survival was about 4.7 months, in a trial population chosen by entry criteria.
- It did not remove the chemotherapy. Bevacizumab was approved for use with 5-fluorouracil-based chemotherapy, not instead of it.
- It did not settle cost, access or the practical burden of infusions every two weeks.
Labels also move. The 2004 label is a historical document; bevacizumab's current label reflects two decades of further evidence and now covers several cancers. Any decision about the drug today rests on the current label and on a person's own situation.
Reading the next approval headline
Three habits help. Find the indication: the exact sentence saying who the drug is for. Find the endpoint. Overall survival, progression-free survival and response rate are not the same thing. Then find the comparison group. A number with nothing to compare it to means very little.
Our overview of colorectal cancer covers stages and treatment, and our targeted therapy page turns this into things you can raise in an appointment.
Sources
- https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125085
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125085lbl.pdf
- https://www.cancer.gov/types/colorectal
- https://seer.cancer.gov/statfacts/html/colorect.html
An AI-assisted editorial system helped prepare this page. No named medical reviewer has reviewed it unless one is listed.
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Put the story in context
Prevention, possible warning signs, screening, and diagnosis
This story relates to Colorectal cancer. The information below is general: it does not reveal anything else about a public person’s health, and not every point applies to every cancer. Personal advice depends on age, symptoms, family history, exposures, and medical history.
Prevention and risk reduction
Not every cancer can be prevented. Avoiding tobacco, protecting skin from ultraviolet radiation, limiting alcohol, staying active, and receiving recommended HPV or hepatitis B vaccination can lower the risk of certain cancers. A risk factor is not a prediction or a cause in one individual.
Symptoms and possible early signs
Possible signs vary and are often caused by conditions other than cancer. Changes worth discussing include a new lump, unexplained bleeding or weight loss, a persistent cough, lasting bowel or bladder changes, a changing skin spot, or symptoms that persist or worsen. Some early cancers cause no symptoms.
Screening and early detection
Screening looks for certain cancers before symptoms begin. Recommended tests exist only for some cancers and depend on age and risk. Screening can have benefits and harms; it is not the same as evaluating a new symptom, and there is no single routine scan or blood test that reliably screens for every cancer.
How cancer is diagnosed
Diagnosis may involve a history and exam, imaging, laboratory tests, and often a biopsy. Pathology can identify the cancer type and may test biomarkers that guide treatment. Symptoms, screening results, tumor markers, or online stories alone cannot confirm cancer.
Learn about this story’s cancer topic
A public story may encourage questions, but it should not be used to estimate your risk or choose testing. Contact a healthcare professional about a persistent or concerning change. Seek urgent care for severe or rapidly worsening symptoms.