Off-label use of Avastin in India hospitalizes 15, sales halted in two states
- Two states in India, Gujarat and Telangana, have halted sales of Roche's Avastin (bevacizumab) after off-label use of the drug led vision problems in 15 patients, Reuters reports.
- Avastin is commonly used off-label to treat wet age-related macular degeneration (AMD) although the FDA has not approved it for that use. The cancer med has been shown to limit vision loss, and doctors often turn to it because it is costs a fraction of Novarti's AMD drug Lucentis' price.
- The drug controller of Gujarat recalled some of the medicine while regulators in Telangana have stopped all sales of the drug in that state. The clustering of the adverse events also raises some questions regarding the authenticity (or potentially the manufacturing quality) of the products at hand.
The main rationale for using Avastin instead of Lucentis in patients with wet AMD is to save money. Both Avastin and Lucentis' mechanism of action involves inhibition of vascular endothelial growth factor (VEGF). VEGF inhibitors reduce the growth of new blood vessels, including in the eyes, thereby decreasing growth of abnormal blood vessels in the central retina of patients with AMD.
The FDA has not approved Avastin for AMD treatment, nor does Roche recommend its off-label use.
Last September, France irked the pharma industry when its pharmaceuticals regulator put a law into effect allowing Avastin to be used to treat AMD. Avastin is considerably cheaper (1/30th of the cost) than Novartis' Lucentis and other drugs indicated for treatment of AMD.
However, Avastin has not been tested for ophthalmic applications. In response to the situation in India, Roche noted using Avastin off-label risks contamination, as reported by Reuters.
As for Novartis, in November 2015, the Swiss company clarified its position on the Avastin versus Lucentis issue. According to a release from Novartis:
- Lucentis and Avastin are different molecules with distinct molecular and pharmacological profiles and are manufactured to different standards.
- Only Lucentis was developed for and is approved by regulatory authorities for use in the eye.
- Avastin is approved and manufactured for intravenous use in cancer patients.
The situation in India was serious enough to warrant surgery for all 15 patients. A week later, six of these patients are still in the hospital. Regulators in India are testing the Avastin used to see if it was a counterfeit version of Avastin.