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تسجيل الدخول/حساب جديد
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الاخبار اخبار الادوية FDA staff release review of Roche's Avastin in breast cancer
الاخبار اخبار الادوية FDA staff release review of Roche's Avastin in breast cancerFDA staff release review of Roche's Avastin in breast cancer
نشر بتاريخ الثلاثاء, 20 تموز/يوليو 2010 00:42 | | 
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| الزيارات: 195
| | الزيارات: 195
In documents posted ahead of an FDA panel meeting July 20 ,
agency staff said that two new studies of Roche's Avastin show that the drug, when paired with chemotherapy, did not extend progression free survival in patients with advanced breast cancer to the same levels observed in a previous trial used to garner approval of the drug in this indication in 2008
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The FDA approval of Avastin as a treatment for breast cancer was based on the E2100 clinical trial, which demonstrated that Avastin plus paclitaxel slowed the spread of breast cancer by an additional 5.5 months, compared with paclitaxel alone
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However, data from the AVADO clinical trial, which was completed post-approval, suggest that a high dose of Avastin used in combination with docetaxel extended progression free survival by 0.9 months, compared with docetaxel alone, according to the staff review. Progression free survival was extended by 0.8 months in patients receiving a lower dose of Roche's drug
A second post-approval trial, RIBBON 1, demonstrated that Avastin combined with taxane or anthracycline-based chemotherapies extended progression-free survival by 1.2 months compared to chemotherapy alone. The review notes that patients receiving Avastin in combination with Xeloda (capecitabine) lived 2.9 months longer than patients receiving chemotherapy alone
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Commenting on the new data, Philippe Bishop, Roche’s vice president of clinical development for Avastin, said "what we have learned through these trials is that there is a consistent magnitude of benefit," adding that "there was no significant increase in overall survival, but what is important in our understanding is that there was also no added detriment."
However, Mirabaud Securities analyst Nick Turner said "my gut feeling would be that it doesn’t look good for Avastin. The real worry here may be that the adverse events associated with Avastin are overriding any anti-cancer effect.
" Citigroup analyst, Mark Dainty, added that "the key question is whether FDA will accept this progression-free survival benefit as a clinical benefit in absence of an improvement in measured quality of life and without a proven extension of survival." Withdrawal of approval may affect as much as $1 billion from annual sales by 2015, according to Sanford C. Bernstein's Jack Scannell.
