In clinical trials over 8 years studying regular, 6-monthly dosing of OCR, there has been no increased risk of malignancy and female breast cancer with OCR, compared with matched reference MS and general populations1–4
Cumulative standardised incidence rates of all malignancies and female breast cancer remained within the range reported in registries
The safety profile of OCR continues to be characterised through the ongoing CTs, post-marketing commitment registries (NIS) and post-marketing data, including routine pharmacovigilance
*There are well-recognised limitations that should be considered when interpreting spontaneous post-marketing safety reports, including events that may not be causally related to drug exposure; in the real-world setting, events are frequently confounded by factors such as multiple drug use and the presence of pre-existing comorbidities; reporting bias may exist for more significant outcomes, which may result in an overrepresentation of the more serious outcomes; and reporting rates can be stimulated by external factors, such as press reports.
The causes of malignancies are recorded as reported to the company; while the company follows up on all reports to identify the cause, an exact diagnosis is not always possible. Some of the investigations remain ongoing and, therefore, the information may be subject to change.
AE, adverse event; CTP, controlled treatment period; IFN β-1a, interferon beta-1a; MedDRA, Medical Dictionary for Regulatory Activities; NIS, non-interventional studies; NMSC, non-melanoma skin cancer; OCR, ocrelizumab; OLE, open-label extension; PPMS, primary progressive MS; pwMS, people with MS; PY, patient-years; RCT, randomised controlled trial; RMS, relapsing MS; SEER, Surveillance, Epidemiology, and End Results Program; SIR, standardised incidence rate.
M-XX-00007056 (Date of preparation: October 2021)