Malignancies

Overview1

Standardised incidence rates

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

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Yearly incidence rates

Cumulative standardised incidence rates of all malignancies and female breast cancer remained within the range reported in registries
 

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Post-marketing

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

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Clinical trials (ocrelizumab all-exposure population)

A: Standardised incidence rates per 100 PY over time of all malignancies (A) and female breast cancer (B)2

standardised incidence rates
incidence of female breast cancer

Yearly incidence rates of all malignancies (A) and female breast cancer (B) in the ocrelizumab all-exposure population*, 2

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Post-marketing experience*,5

As of February 2020:

A total of 57,267 female patients with RMS and PPMS had started OCR in the USA outside of RCTs

Corresponding to an exposure of 79,423 PY

Overall, 98 cases reporting breast cancer were received, resulting in a crude incidence rate of 0.123

Post-marketing
*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.

Abbreviations
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. 

Indications vary in different countries. The local prescribing information from your country is the primary source of information on the known and potential risks associated with ocrelizumab.
References
 
  1. Hauser SL, et al. Neurology 2021;doi:10.1212/WNL.0000000000012700;
  2. Hauser SL, et al. Presented at ECTRIMS 2021 (Poster P724);
  3. Nørgaard M, et al. Mult Scler Relat Disord 2019;28:81–5;
  4. National Institutes of Health (NIH). Overview of the SEER Program. https://seer.cancer.gov/about/overview.html. Accessed 14 October, 2021;
  5. Roche data on file.

M-XX-00007056 (Date of preparation: October 2021)