Genentech is committed to transparent, timely communication of adverse events associated with the use of ocrelizumab in the treatment of relapsing forms of multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). This website is meant to serve as just one of the ways we will provide updated, verified safety information to healthcare professionals (HCPs). We will also be providing safety information routinely through publications and presentations at major multiple sclerosis (MS) congresses.
This website is not a comprehensive source of safety information on ocrelizumab. Due to the nature of post-marketing adverse event reports, information may be duplicate and/or incomplete. Some of the investigations remain ongoing, and therefore the information is subject to change. Additionally, the existence of an adverse event report does not establish causation. We evaluate these reports through our drug safety department, and attempt to verify the information to the extent possible. The Prescribing Information remains the primary source of information on the known and potential risks of ocrelizumab for RMS and PPMS.
An adverse event is an untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have a casual relationship with this treatment. A post-marketing adverse event report is a report received by Genentech regarding an adverse event in a patient taking one of our marketed products.
Following the launch of the searchable FDA Adverse Event Reporting System (FAERS) public dashboard, Genentech received multiple inquiries regarding spontaneously reported fatalities and PML in patients who received ocrelizumab in the post-marketing setting. To address these inquiries and provide timely, accurate information, Genentech created this website. This website serves as just one of the ways in which we plan to communicate safety information. We welcome the FDA's public dashboard and share their vision for data transparency.
Robust global systems are in place to continuously monitor the safety of a drug, from the time it is first evaluated in clinical studies through commercialization. All adverse event reports received by Genentech/Roche are reviewed, assessed, and due diligence is performed. The reports are then submitted to the FDA as per regulatory requirements.
Yes, this website includes post-marketing adverse event reports received by Genentech/Roche. As part of our robust global pharmacovigilance process, these adverse event reports are reviewed, assessed, and due diligence is performed.
The FAERS database generally includes post-marketing cases reported by the Market Authorization Holder. However, FAERS may also include reports from clinical trials based on the specific requirements set in FDA regulations along with reports that are submitted voluntarily to the FDA by other resources. As the FDA acknowledges, unverified information, as well as incomplete or duplicate cases, can be reported in the FAERS dashboard.
The current plan is for the website to be updated quarterly.
You may contact our Medical Communications department or a Medical Science Liaison (MSL) for any questions you may have regarding ocrelizumab. The Prescribing Information is the primary source of information on the known and potential risks of ocrelizumab for RMS or PPMS.
Genentech data on file: December 31, 2020, post-marketing experience; March 27, 2020, clinical trials data cut-off
Genentech data on file: December 31, 2020, post-marketing experience; March 27, 2020, clinical trials data cut-off
Rothman KJ, Greenland S, Lash TL. Modern Epidemiology. 3rd ed. Philadelphia, PA: Lippincott Williams and Wilkins; 2008.
Rothman KJ, Greenland S, Lash TL. Modern Epidemiology. 3rd ed. Philadelphia, PA: Lippincott Williams and Wilkins; 2008.
New Jersey Department of Health and Senior Services. Fact Sheet: Explanation of Standardized Incidence Ratios. March 2010. Available at: https://www.state.nj.us/health/ceohs/documents/eohap/haz_sites/passaic/pompton_lakes/pompton_lakes_fs_sir.pdf.
New Jersey Department of Health and Senior Services. Fact Sheet: Explanation of Standardized Incidence Ratios. March 2010. Available at: https://www.state.nj.us/health/ceohs/documents/eohap/haz_sites/passaic/pompton_lakes/pompton_lakes_fs_sir.pdf.
US Food and Drug Administration. Postmarketing Requirements and Commitments: Reports. https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/ucm064436.htm. Accessed January 2018
US Food and Drug Administration. Postmarketing Requirements and Commitments: Reports. https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/ucm064436.htm. Accessed January 2018
Varallo FR, et al. Clin Ther. 2017;39:686–96.
Varallo FR, et al. Clin Ther. 2017;39:686–96.
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