Genentech receives FDA approval for new use of Avastin plus chemotherapy to treat mCRC

GenentechJan 23 2013

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved a new use of Avastin^® (bevacizumab) in combination with fluoropyrimidine-based irinotecan or oxaliplatin chemotherapy for people 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 majority of people diagnosed with metastatic colorectal cancer receive Avastin plus chemotherapy as their initial treatment," said Hal Barron, M.D., chief medical officer and head of Global Product Development. "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."

Avastin in combination with fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin based chemotherapy is now indicated for the second-line treatment of patients with metastatic colorectal cancer who have progressed on a first-line Avastin containing regimen. The approval is based on positive results from the Phase III ML18147 study, which were presented at the 2012 American Society of Clinical Oncology annual meeting and showed that people who continued to receive an Avastin-based regimen after their cancer worsened lived longer than people who switched to chemotherapy alone.

• The risk of death was reduced by 19 percent for people who received Avastin in combination with standard chemotherapy in both the first- and second-line compared to those who received chemotherapy alone  (HR=0.81, p=0.0057). Median overall survival was 11.2 months compared to 9.8 months.
• The risk of the cancer worsening or death (progression-free survival; PFS) was reduced by 32 percent (HR=0.68, p<0.0001). Median PFS was 5.7 months compared to 4.1 months.
• Overall survival and PFS were calculated from the time patients were randomized to the second-line treatment.
• There was no significant difference in response rate between treatment arms.
• Adverse events (AEs) in ML18147 were consistent with those seen in previous pivotal trials of Avastin in mCRC.

Avastin is the only biologic medicine approved by the FDA to treat people with mCRC in combination with intravenous 5FU-based chemotherapy as an initial treatment, as treatment for people whose cancer worsened after chemotherapy alone, and now as a treatment for people whose cancer has worsened after initial treatment with an Avastin-based regimen. This is the third approval for Avastin in mCRC based on improved overall survival. Avastin is not indicated for adjuvant treatment of colon cancer.

Avastin is approved in Europe in combination with fluoropyrimidine-based chemotherapy for the treatment of adult patients with metastatic carcinoma of the colon or rectum. The European product information has been updated based on the positive results of the Phase III ML18147 study with an implementation date of December 12, 2012, allowing people with mCRC who received Avastin plus chemotherapy as a first-line treatment to continue to receive Avastin plus chemotherapy after their cancer worsens as part of their second-line treatment.