Label Expansion for Roche's Avastin - Analyst Blog
The US Food and Drug Administration (FDA) recently approved Roche 's ( RHHBY ) Avastin (bevacizumab) in combination with fluoropyrimidine-based irinotecan or oxaliplatin chemotherapy for treating patients suffering from metastatic colorectal cancer (mCRC).
Patients suffering from mCRC and initially treated with Avastin along with an irinotecan or oxaliplatin containing chemotherapy may now continue to receive Avastin plus a different irinotecan or oxaliplatin containing chemotherapy if the cancer worsens (second-line treatment).
We note that the FDA's approval was based on encouraging results from a phase III study (ML18147). Results from the study showed that patients continuing with an Avastin-based regimen, even after the worsening of their cancer, survived longer than those who underwent chemotherapy alone. The risk of death for patients who received Avastin plus standard chemotherapy as both the first- and second-line treatment of mCRC, was 19% lower in comparison to patients receiving chemotherapy alone.
Notably, this is Roche's third approval for Avastin as a treatment of mCRC. The drug is already approved by the FDA for treating patients suffering from mCRC in combination with intravenous 5FU-based chemotherapy. Roche has also gained approval for Avastin for treating patients whose cancer worsened after chemotherapy alone.
Avastin plus fluoropyrimidine-based chemotherapy is approved in the EU for the treatment of adults suffering from metastatic carcinoma of the colon or rectum.
We are pleased with Avastin's label expansion. The mCRC market boasts of big players like Bristol-Myers Squibb Company ( BMY ).
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