Avastin/Lucentis Update 25: Comparative Studies Proliferate – France Joins the Fray
According to a story just published in APM Health Europe (September 14, 2009), a French study comparing Roche's Avastin (bevacizumab) and Novartis' Lucentis (ranibizumab) in the treatment of wet age-related macular degeneration (AMD) has enrolled its first patients.
The U.S. CATT Study (Comparison of Age-Related Macular Degeneration Treatment Trials) was launched in February 2008, and a U.K. study is also underway as well as similar studies being carried out in Austria, Germany and Spain.
In France, Professor Gisèle Soubrane of the Creteil hospital outside Paris suggested a comparative study as early as 2006 but failed to secure financing. Early in 2008, the Lyon group of hospitals (HCL) put forward a new protocol and applied for financing. There were various delays and setbacks but the GEFAL (Groupe d'Evaluation Français Avastin versus Lucentis) study is now underway.
The study is sponsored by an academic hospital in Lyon (Hospices Civils de Lyon), the government (via a national research founding program), and the national health insurance system (which reimbursed for Lucentis).
The first recruiting centre in Lyon enrolled an initial patient at the end of June. Contacted by APM last week, Professor Laurent Kodjikian of HCL said: "We have now enrolled 10 patients and by autumn we shall have at least 40 centres."
The GEFAL study is due to enroll 600 patients over a period of 12 to 18 months and they will be monitored for one year.
The French health products safety agency (Afssaps) has been notified that the study involves 46 centres (34 hospitals and 12 private centres).
The study will evaluate the safety and efficacy of Avastin. Provided Avastin is shown to be comparable to Lucentis, the findings should bring down the cost of AMD treatment. This is important since the disease affects elderly people, a population group set to increase.
According to IMS Health figures published in July, in 2008, Lucentis was the 15th most sold drug in France. Turnover was just below 150 million euros. Sales practically tripled between 2007 and 2008.
AFSSAPS RECOMMENDATIONS
Contacted by APM on the off-label use of Avastin since July 2006, Afssaps initially responded by saying it was not in a position to control such use and said it did not intend to communicate with doctors on the matter but later decided to look into the problem.
On Thursday, Afssaps published an information sheet on the off-label use of Avastin, drawing attention to the fact that in its current pharmaceutical form, the product is not adapted to intravitreal administration (insufficient stability data, etc.) and pointing out that the safety data on the use of Avastin in ophthalmology are limited.
The agency says adverse effects with the off-label use of Avastin have been "under-notified" but notes the risk of endophthalmitis/uveitis linked with the injection, and risk of tearing or detachment of the pigment layer of the cornea. Cases of thrombotic side-effects have also been reported.
The agency points out that other products have been authorised for the treatment of wet AMD. Until the results of the GEFAL study and others are available, Afssaps recommends caution in the use of intravitreal Avastin.
Reported by: Sylvie Lapostolle
With the AAO Meeting coming up next month, I expect to hear about the first results of the CATT Study, and perhaps more from some of these other comparative studies as well.
Stay tuned and I will continue to update findings on both the drugs and other technologies for treating AMD.
The U.S. CATT Study (Comparison of Age-Related Macular Degeneration Treatment Trials) was launched in February 2008, and a U.K. study is also underway as well as similar studies being carried out in Austria, Germany and Spain.
In France, Professor Gisèle Soubrane of the Creteil hospital outside Paris suggested a comparative study as early as 2006 but failed to secure financing. Early in 2008, the Lyon group of hospitals (HCL) put forward a new protocol and applied for financing. There were various delays and setbacks but the GEFAL (Groupe d'Evaluation Français Avastin versus Lucentis) study is now underway.
The study is sponsored by an academic hospital in Lyon (Hospices Civils de Lyon), the government (via a national research founding program), and the national health insurance system (which reimbursed for Lucentis).
The first recruiting centre in Lyon enrolled an initial patient at the end of June. Contacted by APM last week, Professor Laurent Kodjikian of HCL said: "We have now enrolled 10 patients and by autumn we shall have at least 40 centres."
The GEFAL study is due to enroll 600 patients over a period of 12 to 18 months and they will be monitored for one year.
The French health products safety agency (Afssaps) has been notified that the study involves 46 centres (34 hospitals and 12 private centres).
The study will evaluate the safety and efficacy of Avastin. Provided Avastin is shown to be comparable to Lucentis, the findings should bring down the cost of AMD treatment. This is important since the disease affects elderly people, a population group set to increase.
According to IMS Health figures published in July, in 2008, Lucentis was the 15th most sold drug in France. Turnover was just below 150 million euros. Sales practically tripled between 2007 and 2008.
AFSSAPS RECOMMENDATIONS
Contacted by APM on the off-label use of Avastin since July 2006, Afssaps initially responded by saying it was not in a position to control such use and said it did not intend to communicate with doctors on the matter but later decided to look into the problem.
On Thursday, Afssaps published an information sheet on the off-label use of Avastin, drawing attention to the fact that in its current pharmaceutical form, the product is not adapted to intravitreal administration (insufficient stability data, etc.) and pointing out that the safety data on the use of Avastin in ophthalmology are limited.
The agency says adverse effects with the off-label use of Avastin have been "under-notified" but notes the risk of endophthalmitis/uveitis linked with the injection, and risk of tearing or detachment of the pigment layer of the cornea. Cases of thrombotic side-effects have also been reported.
The agency points out that other products have been authorised for the treatment of wet AMD. Until the results of the GEFAL study and others are available, Afssaps recommends caution in the use of intravitreal Avastin.
Reported by: Sylvie Lapostolle
With the AAO Meeting coming up next month, I expect to hear about the first results of the CATT Study, and perhaps more from some of these other comparative studies as well.
Stay tuned and I will continue to update findings on both the drugs and other technologies for treating AMD.
posted by Irv Arons @ 12:19 PM
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