FDA Grants BAVENCIO® (avelumab) Approval for a Common Type of Advanced Bladder Cancer (4)

 

FDA Grants BAVENCIO® (avelumab) Approval for a Common Type of Advanced Bladder Cancer (4)

Publicado 09/05/2017 22:11:28CET

This release contains forward-looking information about BAVENCIO (avelumab), Merck-Pfizer's Alliance involving anti-PD-L1 and anti-PD-1 therapies, and clinical development plans, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of BAVENCIO; the uncertainties inherent in research and development, including the ability to meet anticipated clinical study commencement and completion dates and regulatory submission dates, as well as the possibility of unfavorable study results, including unfavorable new clinical data and additional analyses of existing clinical data; risks associated with interim data; the risk that clinical trial data are subject to differing interpretations, and, even when we view data as sufficient to support the safety and/or effectiveness of a product candidate, regulatory authorities may not share our views and may require additional data or may deny approval altogether; whether and when drug applications may be filed in any other jurisdictions for the Indication or in any jurisdictions for any other potential indications for BAVENCIO, combination therapies or other product candidates; whether and when any such applications (including the pending application for BAVENCIO for metastatic Merkel cell carcinoma in the EU) may be approved by regulatory authorities, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of BAVENCIO, combination therapies or other product candidates; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2016, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at http://www.sec.gov and http://www.pfizer.com.

References   

1) BAVENCIO Prescribing Information. Rockland, MA: EMD Serono Inc.; 2017. 2) National Cancer Institute. Bladder Cancer Treatment (PDQ) - Health Professional Version. Available at https://www.cancer.gov/types/bladder/hp/bladder-treatment-pdq. Accessed May 9, 2017. 3) National Comprehensive Cancer Network. NCCN Guidelines Version 1.2017 Updates. Bladder Cancer. Available from: https://www.nccn.org/professionals/physician_gls/pdf/bladder.pdf.    Accessed May 9, 2017. 4) National Cancer Institute. The Surveillance, Epidemiology, and End Results (SEER): Cancer Stat Facts: Bladder Cancer. Available at: https://seer.cancer.gov/statfacts/html/urinb.html. Accessed May 9 [https://seer.cancer.gov/statfacts/html/urinb.html.%20Accessed%20May%209 ], 9 May. (Logo:  http://mma.prnewswire.com/media/477506/Merck_Pfizer_Logo.jpg ) -

(Logo: http://mma.prnewswire.com/media/495843/Bavencio_Logo.jpg )

Photo: http://mma.prnewswire.com/media/477506/Merck_Pfizer_Logo.jpg  http://mma.prnewswire.com/media/495843/Bavencio_Logo.jpg

CONTACT: Merck: Media, Gangolf Schrimpf, +49-6151-72-9591, InvestorRelations: +49-6151-72-3321; Pfizer: Media (US) Sally Beatty+1-212-733-6566, Media (EU) Lisa O'Neill, +44-1737-331536; InvestorRelations: Ryan Crowe, +1-212-733-8160.

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