CHMP recommends approval of Pfizer Zirabev for treatment of multiple cancers
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Last Update: 2020-06-10
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Source: Internet
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Author: User
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, Pfizer, thegiant of thePharmaceutical(http:// announced that the EuropeanPharmaceutical(http://Administration (http://Product
son-in-
(http://Committee (CHMP) had issued a positive opinion recommending approval of Zievrabbevacizumab, bevazumab, developed code: PF-06439535) for the treatment of metastatic colorectal cancer, metastatic breast cancer, non-reprecable advanced metastatic or recurrent non-small cell lung cancer (NSCLC), advanced and / or metastatic renal cell carcinoma, persistent recurrent or metastatic cervical cancerAbout Zirabev
Zirabev is a biosimilar of Roche-branded drug Avastin (generic name: bevacizumab, bevamono) andZirabev is pfizer's second biotic generic for cancer students in Europe in 2018The European Commission (EC) usually adopts CHMP's recommendations when making a final review decision, which means Zirabev is likely to be approved within the next 2-3 monthsZirabev's regulatory filing included a comprehensive packet and evidence confirming Zirabev's biological similarity to Aveitin, including data from the Phase III REFLECTIONS B739-03 Clinical Comparative Study, which confirmed the clinical equivalence of Zirabev and Aveitin in patients treated with late-stage non-scaly NSCLC, and found no clinically significant differences Zirabev has been studied in approximately 400 patients as part of the overall REFLECTIONS clinical research program
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