Understanding Ocrevus Post-Marketing Studies

 The FDA has not completed the key post-marketing requirements (PMRs) related to the original 2017 approval of Ocrevus (ocrelizumab) for relapsing forms of MS (RMS, which includes RRMS) and primary progressive MS (PPMS).Main relevant PMR (malignancy/breast cancer risk)The 2017 approval letter required a prospective longitudinal observational study to evaluate the short- and long-term risks of breast cancer and all malignancies in patients with RMS and PPMS exposed to ocrelizumab. This is being addressed primarily through studies such as:

• VERISMO (BA39731)
• MANUSCRIPT

These studies started in 2018–2019. According to Roche statements and study registries (as of 2026):

• Primary completion is expected around 2029 (MANUSCRIPT) and 2030 (VERISMO).
• Final reports are targeted for late 2030.
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A May 2026 FDA supplement approval letter for Ocrevus explicitly states that postmarketing requirements listed in the original March 28, 2017 approval letter are still open. 

Approval Letter_761053Orig1s038ltr.pdf

The current prescribing information continues to carry the warning that an increased risk of malignancy (including breast cancer) may exist, based on the original clinical trial data, and recommends standard breast cancer screening.Other PMRsSome later or additional requirements have been fulfilled (for example, a pediatric RMS study requirement was marked fulfilled in a 2026 approval letter). Routine post-marketing surveillance continues, and the label has been updated over time for other signals (e.g., immune-mediated colitis, liver injury, PML). Bottom line: The primary long-term post-marketing review of the malignancy signal that was a condition of the 2017 approval for both RMS/RRMS and PPMS is still ongoing and is not expected to be completed until around 2030.