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bevacizumab

Sold as Avastin. Class: VEGF/VEGFR (Vascular Endothelial Growth Factor / -Receptor) inhibitors; Antineovascularisation agents. First FDA approval 02/26/2004: 22 years on the US market.

This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.

A

Score breakdown (91/100)

Safety ×35%
B
Evidence ×25%
A
Regulatory ×15%
A
Money & lawsuits ×15%
A
Options ×10%
C

Safety: 85

Evidence: 100

Regulatory history: 95

Money & lawsuits: 100

Options: 70

Independent reviews and post-approval warnings

WHO Essential Medicine

Listed on the WHO Model List of Essential Medicines: a global expert panel judged it among the medicines a health system should always have, on evidence of value, not marketing.

What the FDA label says

Approved uses

Avastin is a vascular endothelial growth factor inhibitor indicated for the treatment of: Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment. ( 1.1 ) Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen. ( 1.1 ) Limitations of Use : Avastin is not indicated for adjuvant treatment of colon cancer. ( 1.1 ) Unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first-line treatment. ( 1.2 ) Recurrent glioblastoma in adults. ( 1.3 ) Metastatic renal cell carcinoma in combination with interferon alfa. ( 1.4 ) Persistent, recurrent, or metastatic cervical cancer, in combination with paclitaxel and cisplatin, or paclitaxel and topotecan. ( 1.5 ) Epithelial ovarian, fallopian tube, or primary peritoneal cancer: in combination with carboplatin and paclitaxel, followed by Avastin as a single agent, for stage III or IV disease following ...

Contraindications

None. None ( 4 )

Warnings and precautions

Gastrointestinal Perforations and Fistula : Discontinue for gastrointestinal perforations, tracheoesophageal fistula, grade 4 fistula, or fistula formation involving any organ ( 5.1 ) Surgery and Wound Healing Complications : In patients who experience wound healing complications during Avastin treatment, withhold Avastin until adequate wound healing. Withhold for at least 28 days prior to elective surgery. Do not administer Avastin for at least 28 days following a major surgery, and until adequate wound healing. The safety of resumption of AVASTIN after resolution of wound healing complication has not been established. Discontinue for wound healing complication of necrotizing fasciitis. ( 5.2 ) Hemorrhage: Severe or fatal hemorrhages have occurred. Do not administer for recent hemoptysis. Discontinue for Grade 3-4 hemorrhage ( 5.3 ) Arterial Thromboembolic Events (ATE) : Discontinue for severe ATE. ( 5.4 ) Venous Thromboembolic Events (VTE) : Discontinue for Grade 4 VTE. ( 5.5 ) Hypertension : Monitor blood pressure and treat hypertension. Withhold if not medically controlled; resume once controlled. Discontinue for hypertensive crisis or hypertensive encephalopathy. ( 5.6 ) Poste...

Adverse reactions (label)

The following clinically significant adverse reactions are described elsewhere in the labeling: Gastrointestinal Perforations and Fistulae [see Warnings and Precautions (5.1) ] . Surgery and Wound Healing Complications [see Warnings and Precautions (5.2) ]. Hemorrhage [see Warnings and Precautions (5.3) ]. Arterial Thromboembolic Events [see Warnings and Precautions (5.4) ]. Venous Thromboembolic Events [see Warnings and Precautions (5.5) ]. Hypertension [see Warnings and Precautions (5.6) ]. Posterior Reversible Encephalopathy Syndrome [see Warnings and Precautions (5.7) ]. Renal Injury and Proteinuria [see Warnings and Precautions (5.8) ]. Infusion-Related Reactions [see Warnings and Precautions (5.9) ]. Ovarian Failure [see Warnings and Precautions (5.11) ]. Congestive Heart Failure [see Warnings and Precautions (5.12) ]. Most common adverse reactions incidence (incidence > 10%) are epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, hemorrhage, lacrimation disorder, back pain and exfoliative dermatitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Genentech, Inc. at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 ...

Recent major label changes

Indications and Usage ( 1.1 ) 9/2022 Dosage and Administration ( 2.2 ) 9/2022 Warnings and Precautions, Infusion-Related Reactions ( 5.9 ) 9/2022

Source: FDA SPL label for Avastin (Genentech, Inc.), effective 20250106. Full label on DailyMed.

Side-effect reports sent to the FDA

These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.

91,819reports that mention this drug
91,774of those blame this drug, not another one the person was taking
90%of reports describe a serious outcome, such as a hospital stay (average for all drugs: 57%)
21.0%of reports include a death, from any cause (average for all drugs: 9.1%)

Problems reported most often

Off Label Use · 14,169Death · 9,203Diarrhoea · 5,679Fatigue · 5,461Disease Progression · 5,152Nausea · 5,148Hypertension · 4,733Vomiting · 3,671Anaemia · 3,670Neutropenia · 3,268Drug Ineffective · 3,007Pyrexia · 2,989Decreased Appetite · 2,964Asthenia · 2,890Thrombocytopenia · 2,756

Reports per year

20192020202120222023202420252026
6,5356,6117,9858,0848,8468,4818,8074,335

Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.

Recalls and regulatory record

0recall actions on file
0 / 0brand / generic applications
0label changes since 2021
NoREMS program

Evidence base

1,109randomized trials (PubMed)
345systematic reviews
3,404registered trials
57%of completed trials posted results
14%terminated or withdrawn
43%industry-funded

Independent Cochrane reviews

Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.

Money and lawsuits

In 2024, drug companies reported $37,424 in payments to US physicians and hospitals tied to this drug across 655 transactions (Avastin $37,424).

No pending federal MDL names this drug or its brands.

Not named in any federal pharmaceutical settlement of $100M or more on record.

Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.

Who takes it and what it costs

335Medicare Part D patients (2024)
1,712prescriptions filled
$5,276average cost per fill
$9Mtotal Medicare spend

Same-class alternatives

brolucizumabpegaptanibramucirumabverteporfin

Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.

Questions to ask your prescriber

  1. The most-reported problems in FDA's adverse event data are death, diarrhoea, fatigue. How would we recognize and handle those?
  2. Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?
  3. Why this one over aflibercept, brolucizumab, faricimab? What would make you pick one of those instead?
  4. There is no generic. Is there an older generic in the same class that works as well for my situation?
  5. What result are we expecting, by when, and what is the plan if it does not happen?
  6. If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)