The FDA has approved a new use for Avastin (Genentech; bevacizumab) in combination with fluoropyrimidine-based irinotecan or oxaliplatin chemotherapy for use in patients with metastatic colorectal cancer (mCRC). The new indication will allow people who received Avastin plus an irinotecan- or oxaliplatin-containing chemotherapy as an initial treatment (first-line) for mCRC to continue to receive Avastin plus a different irinotecan- or oxaliplatin-containing chemotherapy after their cancer worsens (second-line treatment).
The approval is based on positive results from the Phase III ML18147 study, which showed that people who continued to receive an Avastin-based treatment regimen after their cancer worsened lived longer than people who switched to chemotherapy alone.
“The majority of people diagnosed with metastatic colorectal cancer receive Avastin plus chemotherapy as their initial treatment,” said Hal Barron, MD, chief medical officer and head of global product development at Genentech, in a press release. “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 ML18147 study was a randomized, open-label, multicenter, multinational trial evaluating the efficacy and safety profile of Avastin plus standard second-line chemotherapy in 820 patients with mCRC whose disease had progressed following Avastin plus standard first-line chemotherapy (irinotecan- or oxaliplatin-based). The primary end point of the trial was overall survival measured from the time patients were randomized to receive the second-line treatment.
Results showed that the risk for death was reduced by 19% in patients who received Avastin in combination with standard chemotherapy in both first- and second-line, compared with those who received chemotherapy alone (hazard ratio, 0.81; P=0.0057). The median overall survival was 11.2 months in the Avastin group compared with 9.8 months in the chemotherapy-alone group.
Adverse effects in the trial were consistent with those seen in previous pivotal trials of Avastin in mCRC. Avastin contains several boxed warnings: In clinical trials, some people treated with Avastin experienced serious and sometimes fatal side effects, including gastrointestinal perforation, surgery and wound-healing problems, and severe bleeding.
—Based on a press release