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Avastin

Description Avastin® (bevacizumab) is a recombinant humanized antibody designed to specifically bind to a protein called vascular endothelial growth factor (VEGF) that plays an important role throughout the lifecycle of the tumor to develop and maintain blood vessels, a process known as angiogenesis. Avastin is designed to interfere with the blood supply to a tumor by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells. Avastin does not bind to receptors on normal or cancer cells. The tumor blood supply is thought to be critical to a tumor's ability to grow and spread in the body (metastasize).

Development Status In the second half of 2009, we plan to submit data from two clinical trials, RIBBON-1 and AVADO data, for first-line HER2-negative metastatic breast cancer in order to convert the accelerated approval in first-line HER2-negative metastatic breast cancer to a full approval.

Genentech is evaluating Avastin across more than 30 different cancer types in a broad late-stage clinical development program that involves more than 450 clinical trials worldwide. It is being studied in combination with a variety of chemotherapy regimens as well as with targeted medicines, such as Herceptin, Rituxan and Tarceva. Clinical trials are also ongoing or planned evaluating Avastin in combination with investigational targeted agents, such as DR5-Agonist Antibody (PRO95780), dulanermin, Hedgehog Pathway Inhibitor (GDC-0449), MetMAb and PI3 Kinase Inhibitor (GDC-0941).

Genentech is evaluating Avastin across more than 30 different cancer types in a broad late-stage clinical development program that involves more than 450 clinical trials worldwide. It is being studied in combination with a variety of chemotherapy regimens as well as with targeted medicines, such as Herceptin, Rituxan and Tarceva. Clinical trials are also ongoing or planned evaluating Avastin in combination with investigational targeted agents, such as DR5-Agonist Antibody (PRO95780), dulanermin, Hedgehog Pathway Inhibitor (GDC-0449), MetMAb and PI3 Kinase Inhibitor (GDC-0941).

Approved Uses

  • In February 2004, the FDA approved Avastin for use in combination with intravenous 5-Fluorouracil (5-FU)-based chemotherapy as a treatment for patients with first-line metastatic cancer of the colon or rectum.
  • In June 2006, the FDA approved Avastin for use in combination with intravenous 5-FU-based chemotherapy for patients with second-line metastatic cancer of the colon or rectum.
  • In October 2006, the FDA approved Avastin in combination with carboplatin and paclitaxel for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer.
  • In August 2009, the FDA approved Avastin in combination with interferon-alfa for the treatment of patients with metastatic renal cell carcinoma.

BOXED WARNINGS and Additional Important Safety Information Patients treated with Avastin may experience side effects. In clinical trials, some patients treated with Avastin experienced serious side effects, including:

Gastrointestinal (GI) perforation:
Treatment with Avastin can result in the development of a serious side effect called GI perforation, which is the development of a hole in the stomach, small intestine, or large intestine. In clinical trials, this side effect occurred in 0.3 to 2.4% of patients and in some cases resulted in fatality. Avastin therapy should be permanently stopped in people with GI perforation.

Surgery and wound healing problems:
Treatment with Avastin can lead to slow or incomplete wound healing (for example, when a surgical incision has trouble healing or staying closed). In some cases this event resulted in fatality. In a clinical trial, 15% of patients with metastatic colorectal cancer who had surgery while receiving Avastin treatment had serious and fatal complications compared to 4 percent of patients who did not receive Avastin. Avastin should not be initiated for at least 28 days following surgery and until the surgical wound is fully healed. Avastin therapy should be permanently stopped in patients with wound healing problems that require medical treatment. The appropriate waiting time between stopping treatment with Avastin and having surgery has not been determined.

Severe bleeding:
Severe or fatal bleeding, including hemoptysis (coughing up of blood), GI bleeding, hematemesis (bloody vomit), central nervous system (CNS) hemorrhage (bleeding in the brain), epistaxis (nose bleeds), and vaginal bleeding occurred up to five-fold more frequently in patients receiving Avastin compared to patients receiving only chemotherapy. Across indications, Grade 3 or higher (severe or fatal) bleeding events have occurred in 1.2 to 4.6% of patients receiving Avastin. In patients with previously treated glioblastoma, intracranial hemorrhage (bleeding within the brain) occurred in 8 of 163 patients and two people had Grade 3 to 4 (severe) bleeding. In patients treated with Avastin and chemotherapy for lung cancer, serious and sometimes fatal pulmonary hemorrhage (bleeding in the lungs) occurred in 4 of 13 (31%) patients with squamous cell histology, and 2 of 53 (4%) patients with non-squamous NSCLC compared to none of 32 (0%) patients treated with chemotherapy. People with serious bleeding or recent hemoptysis should not receive Avastin.

In clinical trials, additional serious side effects seen across different cancer types, in some cases resulting in fatality, included the following: formation of an abnormal passage from parts of the body to another part (non-GI fistula formation - less than 0.3%); stroke or heart problems (arterial thromboembolic events - 2.6%); high blood pressure (5 to 18%); nervous system and vision disturbances known as RPLS (reversible posterior leukoencephalopathy syndrome - less than 0.1%); severe infusion reactions (0.2% of people), and too much protein in the urine, and kidney damage (nephrotic syndrome - less than 1%).

The most common adverse reactions observed in Avastin patients at a rate of more than 10 percent and at least twice the control arm rate, were nose bleeds, headache, high blood pressure, irritation of the nose (rhinitis), protein in the urine, taste alteration, dry skin, rectal bleeding, tear production disorder (lacrimation), and inflammation of the skin (exfoliative dermatitis).

Avastin may cause problems getting pregnant. People who are pregnant or thinking of becoming pregnant should talk with their doctor about the potential risks of loss of pregnancy or the potential risk of Avastin to the fetus. Nursing mothers should not breast-feed while receiving Avastin or for a short period of time after treatment is finished.

For Avastin full prescribing information, including Boxed WARNINGS and additional important safety information, please visit http://www.avastin.com.

Additional Information on Clinical Trials For inquiries about our clinical trials, please submit a request through our information request form or call (888) 662-6728.

National Institutes of Health Website: www.clinicaltrials.gov

September 2009