Which 15 cancer indications are specifically listed in the MHRA approval for injectable nivolumab?
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Executive summary
The MHRA’s April 30, 2025 announcement authorised a subcutaneous (under‑the‑skin) formulation of nivolumab for use across a broad range of solid‑tumour indications and stated the approval covers 15 cancer types, but the public press release lists only a subset and the full Summary of Product Characteristics (SmPC) was to be published within days for the definitive list [1]. Reporting from NHS England, Bristol Myers Squibb and secondary outlets repeats the “15 cancers” claim and cites many of the same tumour sites, while the FDA’s prior approval of a subcutaneous nivolumab product lists overlapping solid‑tumour indications that illuminate — but do not by themselves confirm — the exact 15 indications the MHRA licensed [2] [3] [4].
1. What the MHRA publicly declared and what it did not
The MHRA press release confirms national approval of the new subcutaneous nivolumab formulation and explicitly names several tumour sites included under the approval — kidney (renal), skin (melanoma), lung, head and neck, bladder (urothelial), bowel (colorectal), liver (hepatocellular), stomach (gastric) and cancers of the oesophagus — while also stating that the full SmPC and Patient Information Leaflet would be published on the MHRA website within seven days [1]. That statement is authoritative about the regulator’s action but does not itself enumerate all 15 discrete indications claimed in other statements, and the press release warns clinicians to consult the forthcoming SmPC for the complete, legally binding list [1].
2. How other UK stakeholders framed the approval
NHS England and multiple industry and patient‑group write‑ups repeat the headline that the product is authorised for “15 cancers” and stress the practical benefits (3–5 minute administration, clinic capacity saved), but these communications mirror the MHRA’s broad language rather than providing a definitive point‑by‑point list of the 15 licensed indications [2] [3] [5]. NHS England’s rollout announcement and Bristol Myers Squibb’s statements are consistent with the regulator’s press release but rely on the SmPC to resolve the precise clinical indications and dosing schedules [2] [3].
3. The indications that appear across MHRA and FDA materials
Across the MHRA release and the FDA approval of a related subcutaneous nivolumab product, the tumour types repeatedly named are: renal cell carcinoma (kidney), melanoma (skin), non‑small cell lung cancer (lung), head and neck squamous cell carcinoma, urothelial carcinoma (bladder), colorectal cancer (bowel), hepatocellular carcinoma (liver), oesophageal carcinoma (oesophagus), gastric cancer (stomach), gastroesophageal junction cancer, and esophageal adenocarcinoma — all of which are identified in at least one of the sources provided [1] [4]. These overlapping lists account for the majority of cancer types cited in UK and US communications about subcutaneous nivolumab, but do not, given the available reporting, prove the MHRA’s exact 15‑item enumeration on their own.
4. Why a definitive numbered list cannot be asserted from the provided reporting
The MHRA press release explicitly promised the SmPC/PIL within seven days and several UK outlets echoed the “15 cancers” total without reproducing a full itemised list; the FDA document lists many — but not necessarily the same complete set the MHRA licensed — and the SmPC is the legally binding reference for precise indications [1] [4]. Therefore, while multiple sources consistently name at least 10–11 tumour types included under the new subcutaneous approval, the complete set of 15 specific indications as enumerated by the MHRA cannot be verified from the supplied excerpts alone; the SmPC or the MHRA’s product page must be consulted to read the regulator’s formal, final list [1].
5. Practical takeaway and where to look next
Clinicians and patients should treat the MHRA press release as confirmation that subcutaneous nivolumab is nationally authorised for multiple solid‑tumour indications and expect the full SmPC to provide the exact 15‑indication list and prescribing details; until that SmPC or the MHRA product listing is consulted, any reconstructed 15‑item list drawn from news coverage and the FDA approval will be informed but not definitive [1] [4]. Secondary reporting from NHS England and specialist outlets is useful for context — access, trial basis (CheckMate‑67T) and workforce implications — but the SmPC remains the source of record for the legally authorised indications [2] [6].