Roche's blockbuster cancer drug Avastin has added to its list of indications in the US with a new approval for its use in people with metastatic colorectal cancer (mCRC).
The drug is already licensed for use in combination with chemotherapy as a first-line treatment for people with the condition, but Avastin (bevacizumab) can now also be used alongside a different chemotherapy as a second-line treatment if the disease progresses.
“The majority of people diagnosed with metastatic colorectal cancer receive Avastin plus chemotherapy as their initial treatment,” said Dr Hal Barron, Roche's 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.”
The FDA approval is based on the phase III ML18147 study, data from which demonstrated that people with mCRC who continued to receive Avastin in combination with fluoropyrimidine-based irinotecan or oxaliplatin chemotherapy lived longer than people who switched to chemotherapy alone.
The median progression-free survival for people in the Avastin arm of the trial was 5.7 months compared to 4.1 months in the non-Avastin arm - a reduction in risk of progression-free survival of 32 per cent.
These results have already seen Avastin's European product information updated in December, 2012, allowing people with mCRC who received the Avastin regimen as a first-line treatment to continue to receive Avastin as part of a second-line treatment.
The latest FDA approval is the second major regulatory milestone for Avastin in recent months after it was cleared in the EU for the treatment of recurrent ovarian cancer in November, 2012.
In addition to its colorectal cancer indications in the US, it is also approved to treat non-small cell lung cancer (NSCLC), kidney cancer and progressive glioblastoma, while in Europe it is available for use in the treatment of advanced stages of breast cancer, colorectal cancer, NSCLC, kidney cancer and ovarian cancer.
The drug is one of Roche's most successful products and achieving sales of 2.81bn Swiss francs (about €2.25bn) during the first six months of 2012.