Anktiva NHS access has no NICE recommendation behind it. The medicine holds a UK licence for BCG-unresponsive bladder cancer. However, NICE ended its appraisal in June 2026 because ImmunityBio did not submit evidence.
The question matters again because of a US decision. On 14 October 2026, the US Food and Drug Administration (FDA) widened Anktiva’s label, according to Fierce Pharma. The new use is high-grade, papillary-only disease. Anktiva is the brand name for nogapendekin alfa inbakicept, given with BCG.
A search on 15 October 2026 found no UK decision on that wider use. It also found no change to the NICE position.
Can UK patients get Anktiva on the NHS?
Not through a NICE recommendation, on the published record. NICE terminated its technology appraisal, TA1163, and said it could not make a recommendation. The notice records ImmunityBio’s view that the technology is “unlikely to be a cost-effective use of NHS resources.”
NICE also said it will review its position if the company decides to make an evidence submission. The notice gives no timeline. None of the pages read on 15 October 2026 gave a date for a submission.
Because no evidence was submitted, the notice carries no NICE judgement on benefit or value for money. A terminated appraisal is therefore not a finding that the drug fails to work. It is a finding that NICE had nothing from the company to assess.
That leaves Anktiva NHS access open to question for every group in the US label, including papillary-only disease.
Where the UK licence stands
The Medicines and Healthcare products Regulatory Agency (MHRA) approved the medicine on 4 July 2025, according to its announcement. It used the International Recognition Procedure, which draws on decisions by trusted regulatory partners. The announcement describes the use as adults with BCG-unresponsive non-muscle invasive bladder cancer. It does not say whether the authorisation is conditional.
NICE’s final scope, issued in October 2025, words the UK authorisation more narrowly. It covers carcinoma in situ, with or without papillary tumours. Papillary-only disease is not named.
The scope wording matters for Anktiva NHS access in papillary-only disease. NICE said it would issue guidance only in line with the authorisation.
OncLive reported in February 2026 that the European Commission granted a conditional authorisation. That covered the carcinoma in situ use.
A search of the electronic medicines compendium on 15 October 2026 returned no Anktiva entry. No UK summary of product characteristics could therefore be read. The UK label for papillary-only disease is unconfirmed, and no MHRA statement on it was found.
What the FDA approved on 14 October 2026
Fierce Pharma reported that the FDA approved Anktiva with BCG for BCG-unresponsive, high-grade, papillary-only non-muscle invasive bladder cancer. It said the decision came nearly three months before the agency’s target date. OncLive reported the target date as 6 January 2027. ImmunityBio announced FDA acceptance of the filing in May 2026.
The FDA’s 2024 approval had covered carcinoma in situ, with or without papillary tumours. OncNursingNews and OncoDaily reported that the new decision extended that evidence to papillary-only disease. OncoDaily cautioned that the carcinoma in situ response rates should not be read as direct results for papillary-only tumours.
The path was not smooth. The US decision does not itself change Anktiva NHS access, because UK decisions rest on the MHRA and NICE. Fierce Pharma reported that the FDA issued a refusal-to-file letter in May 2025. It said ImmunityBio refiled in March 2026. The FDA had earlier told the company that a randomised trial was needed, according to the same report.
Fierce Pharma also reported on a rival, Johnson & Johnson’s Inlexzo. It won a carcinoma in situ approval in September 2025. J&J is running a phase 3 trial, Sunrise-5, in papillary disease.
Fierce Pharma said the FDA is finalising draft guidance on developing drugs for BCG-unresponsive disease. The guidance covers using carcinoma in situ evidence to support papillary-only approval.
The evidence behind the label
The 2024 FDA notice describes a single-arm trial of 77 patients. The complete response rate was 62 per cent (95 per cent confidence interval 51 to 73). Among complete responders, 58 per cent had a response lasting at least 12 months. For 40 per cent, it lasted at least 24 months.
The papillary-only group, Cohort B, enrolled 80 patients, according to OncLive. Disease-free survival was 58.2 per cent at 12 months (95 per cent confidence interval 46.6 to 68.2). At 24 months it was 52.1 per cent. OncNursingNews reported 38.2 per cent at 36 months, with median disease-free survival of 25.3 months. It also reported cystectomy avoidance of 92.2 per cent at 12 months and 81.8 per cent at 36 months.
Cohort B had no comparator arm. OncLive also reported a guideline change in March 2026. The National Comprehensive Cancer Network added the combination for papillary-only disease as a category 2A recommendation.
Safety findings reported so far
The FDA notice lists the most common reactions, at 15 per cent or more. They include increased creatinine, dysuria, haematuria and urinary tract infection.
OncLive reported pooled safety data from 180 patients across both cohorts. Grade 1 or 2 treatment-related events occurred in 61 per cent. Grade 3 events occurred in 3 per cent. No grade 4 or 5 treatment-related events were reported. The pooled figures do not separate the papillary-only cohort.
What current NHS options look like
NICE’s final scope lists the comparators it would have used. They are radical cystectomy, intravesical chemotherapy, BCG re-challenge and best supportive care. Radical cystectomy means surgical removal of the bladder. The list shows what NICE treated as the existing options in this setting. The US trial data do not compare Anktiva with any of them.
What could change Anktiva NHS access
Three developments could settle the position. First, ImmunityBio could submit evidence to NICE, which NICE says it would then review. Second, the MHRA could publish a decision on papillary-only use. Third, an emc entry could show the UK label wording. No source gave a date for any of the three. Each step would move Anktiva NHS access forward only if it ended in a NICE recommendation.
NICE’s in-development page for the same product, ID6582, still showed the appraisal as in progress on 15 October 2026. It listed a provisional committee meeting for 9 September 2026. That date has passed. The page appears to lag the termination notice, and the notice is the more specific document.
NICE timetables for other recent US approvals vary. The appraisal of atezolizumab for dMMR colon cancer was in scoping on 11 October 2026. The FDA drug approval decisions tracker logs the wider US picture.
What remains unknown
Several points are open. No source read for this article gave an ImmunityBio plan for a UK submission in papillary-only disease. No UK clinician or NHS commissioner comment was found. The papillary-only data come from a single-arm cohort. NHS commissioning arrangements for Anktiva were not examined for this article.
The answer to the lasting question will turn on two documents. One is a NICE review after any ImmunityBio submission. The other is the UK product information. Until either appears, Anktiva NHS availability rests on a licence without a NICE recommendation. That is the published position as of 15 October 2026.
