Roche investigating off-label Avastin use after 15 Indian patients hospitalized
- Roche will begin an internal investigation into the use of its cancer drug Avastin for off-label treatment of macular degeneration in India, reports The Economic Times. Sales of Avastin were halted last week in two Indian states, Gujarat and Telangana, after 15 patients went to the hospital with vision problems.
- Roche has emphatically reiterated Avastin is not approved for intraocular use by the FDA or the Indian government, even though it has long been used by physicians in different countries for treatment of age-related macular degeneration (AMD).
- The cancer med has been shown to limit vision loss, and doctors often turn to it because it is costs a fraction of Novartis's AMD drug Lucentis' price.
Last week, the Drug Controller of India released an alert reminding health officials that Avastin is not approved for ophthalmological purposes. The alert directed state regulatory authorities to "monitor the movement of the said drug and its use in ophthalmology."
Roche has stood by its response that Avastin is only approved for treatment of certain cancers, rather than ocular disease.
The AMD market in India is growing, as has off-label use of Avastin due to the cost of Novartis' approved AMD med Lucentis. The occurrence of these serious adverse events has drawn the spotlight onto this common practice.
Some reports indicated health authorities in the two Indian states are investigating whether the hospitalized patients may have been given counterfeit versions of Avastin.
- Economic Times of India Roche begins probe into Avastin use for eye ailments
- BioPharma Dive Off-label use of Avastin in India hospitalizes 15, sales halted in two states