Avastin Case Study

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Kind of cancer Endpoint Results* Treatment NSCLC OS 2 months Avastin + chemotherapy mRCC PFS 4.8 months Avastin + interferon alfa CC OS 3.9 months Avastin + chemotherapy prOC PFS 3.4 months Avastin + chemotherapy * Difference between the Avastin treatment and the traditional treatment. All Avastin results show an increased in the OS or PFS when are compared to the traditional treatment Table 5. Result of clinical trials of Avastin for the treatment of lung, renal, cervical and ovarian cancer Production systems and processes: Avastin is produced through recombinant biotechnology in Chinese hamster ovary (CHO) mammalian cell expression systems suspended in growth media with antibiotic. The humanized antibody is constituted by a murine fraction…show more content…
If a batch of bevacizumab has a volume of 14 L, this will generate 1000 vials or 800 vials in the presentations of 100 or 400 mg/vial, respectively and if its produced a batch of 1372 L, this will result in 311000 vials or 83000 vials in the presentations of 100 or 400 mg/vial, respectively [13]. Prior to the filling process, a filtration step is made and the sterile filling is achieved in a nitrogen and steam atmosphere in which the product is maintained at 2 to 8°C. The package used is depyrogenated Type I glass vials with a steam sterilised stopper and aluminium flip off caps. All the filling equipment must be sterilised and the inspection of filled vials is done for each unit produced at the end of the process [13]. Avastin is manufactured in Genentech South San Francisco and Genentech Vacaville with the filling process in San Francisco site. Both facilities are GMP compliance [13]. The process for the production of Avastin is shown in the Figure 2. Figure 2. Manufacturing process of Avastin [13] Registration and sales of Avastin: Genentech a member of the Roche manufactures Avastin. Roche holds the patent numbers US6054297 [16] and WO1992022653 [17] for Avastin and the marketing authorization in: Australia [18]: • Australian Registration Number of Avastin 100 mg/4 mL: AUST R 99755 • Australian Registration Number of Avastin 400 mg/16 mL: AUST…show more content…
During 2014, the worldwide sales of Avastin increased in a 6% related to 2013, reporting $7,3 billion US dollars on sales (Figure 3) [19] [21]. In EU sales were mainly derived from ovarian cancer treatment and other indications; in USA, sales were derived from colorectal, cervical and ovarian cancer; in Japan sales were derived from breast cancer, ovarian cancer and malignant glioma. In the rest of the world sales were increased due to launching of Avastin in new markets for colorectal cancer and ovarian cancer [19]. Sales were also positively affected due to the FDA approval of Avastin for the treatment of persistent, recurrent or metastatic CC in combination with chemotherapy in August 2014, the approval for the treatment of recurrent prOC in November 2014 in addition to the EMA approval for the treatment of prOC on June 2014 [19]. Avastin sales per year (US billion dollars) Year 2014 2013 2012 2011 2010 2009 2008 2007 2006 Sales 7.37 6.91 6.29 6.23 6.34 5.59 4.49 3.10

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