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ANSM wants company data on the benefits and risks of using Avastin over Lucentis in the treatment of wet age-related macular degeneration.
French agency Agence Nationale de Sécurité de Médicament et des Produits de Santé (ANSM) wrote a letter to Roche, which ANSM posted on its website on Nov. 6, 2014, asking the pharmaceutical company to provide data on the use of Avastin (bevacizumab) to treat wet age-related macular degeneration (AMD), an off-label use of the drug. Avastin is approved to treat metastatic colorectal cancer, advanced nonsquamous non-small cell lung cancer, metastatic renal cell carcinoma, and recurrent glioblastoma.
Avastin is often used off-label over Lucentis (ranibizumab injection) to treat chronic eye disease AMD, as Lucentis costs approximately 30 times more than Avastin. Therapies for AMD require repeated treatment to prevent vision loss, so costs for Lucentis can quickly add up. According to the letter from ANSM, the method of action of Avastin in the eye is similar to that of Lucentis, making it a cheaper option with comparable results. ANSM plans to use its own research via a “risk-benefit committee,” coupled with the information requested from Roche on the safety and efficacy of Avastin for AMD, to make a recommendation on the use of the drug in the first part of 2015. ANSM also wants to use the information from Roche to estimate the number of patients potentially affected by this off-label use in France and propose a draft protocol for monitoring patients.
Allowing off-label use of a medication without clinical trials may be considered risky, as FDA has not approved Avastin for AMD. However, both Avastin and Lucentis were found to be highly effective (equivalent) to treat visual acuity in a two-year Comparison of AMD Treatments Trials (CATT), and these results were published both in the journal Ophthalmology and the New England Journal of Medicine. Physicians in Europe and the US already use Avastin to treat AMD, and some pharmacies offer to split the dosage of Avastin into smaller portions for eye injections. Splitting the doses in this manner, however, can introduce the risk of bacterial contamination in the vials as a result of the extra handling. Contamination of this kind can lead to infection and blindness, as the New York Times reported in 2011.
Meanwhile, Novartis and Roche, the makers of Avastin, have discouraged the substitution of Avastin for Lucentis, even though Roche can stand to benefit from the sale of both Lucentis and Avastin. “We have received the letter regarding the evaluation process in wet AMD to be started and we will of course fully cooperate with the authorities," a Roche spokeswoman told Reuters. "Our position regarding the use of Avastin in wet AMD has not changed."
ANSM, as translated by Google Translator