The U.S. Food and Drug Administration (FDA) has approved use of Roche’s Avastin for patients with colorectal cancer that has gotten worse despite treatment with the medication.
This new approval will permit patients who were already treated once with Avastin plus chemotherapy to be treated again with Avastin in combination with a different chemotherapy regimen.
Hal Barron, MD, Roche’s Chief Medical Officer and Head of Global Product Development said:
“The majority of people diagnosed with metastatic colorectal cancer receive Avastin plus chemotherapy as their initial treatment. These people now have the option to continue with Avastin plus a new chemotherapy after their cancer worsens, which may help them live longer than changing to the new chemotherapy alone.”
The new approval is based on the results of a Phase III study that were presented at the 2012 American Society of Clinical Oncology annual meeting, and revealed that people who continued to receive an Avastin regimen after their cancer progressed, lived longer compared with people who changed to just chemotherapy alone.
Avastin, commonly known as bevacizumab is an antibody that inhibits vascular endothelial growth factor (VEGF), a protein that tumors require to develop nutrient-providing blood vessels.
Avastin is the only medicine with FDA approval to treat patients with metastatic colorectal cancer combined with intravenous 5FU-based chemotherapy as first treatment, as well as treatment for people whose cancer has intensified after chemotherapy by itself, and now as a treatment for people whose cancer has intensified after an Avastin-based regimen.
Avastin has already been approved in Europe for combination use with fluoropyrimidine-based chemotherapy for the treatment of metastatic carcinoma of the colon or rectum.
The phase II was a randomized, open-label, and multinational trial that measured the safety and efficacy of Avastin plus standard second round chemotherapy in 820 patients with mCRC whose disease had developed further after Avastin plus standard first-line chemotherapy.
One group was given chemotherapy plus Avastin and the other group just had chemotherapy alone.
Findings showed that…:
- The risk of death decreased by 19 percent for people who took Avastin in combination with standard chemotherapy in both the first and second rounds compared with those who just underwent chemotherapy alone. Middle value survival rate was 11.2 months compared to 9.8 months
- The risk of cancer becoming worse or death (progression-free survival) fell by 32 percent. Middle value progression-free survival rate was 5.7 months compared 4.1 months.
- Total survival and progression-free survival were measured from the time patients were randomized to the second-line treatment.
- Adverse effects were similar to those seen in previous trials of Avastin.
Colorectal cancer is one of most common cancers around the world, with more than 1.2 million new cases diagnosed annually. It causes over 600,000 deaths internationally every year. When diagnosed with colorectal cancer, 40 percent of patients are already at an advanced stage and require surgery.
Risk factors for colorectal cancer include:
- old age
- diet high in fat, animal protein, and calories
- family history of colorectal cancer
- having Crohn’s disease or Irritable Bowl Syndrome
Written by Kelly Fitzgerald