{
  "schema_version": "1.0",
  "type": "article",
  "title": "Soon-Shiong Beats the FDA Clock on Anktiva",
  "url": "https://drugnews.com.tw/articles/2026-10-18-immunitybio-anktiva-papillary-early-approval-en.html",
  "markdown_url": "https://drugnews.com.tw/articles/2026-10-18-immunitybio-anktiva-papillary-early-approval-en.md",
  "lang": "en",
  "date": "2026-10-18",
  "publish_at": "2026-10-18T08:00:00+08:00",
  "updated_at": "2026-10-18",
  "category": "商業分析系列",
  "topic": "商業分析系列",
  "tags": [
    "ImmunityBio",
    "Anktiva",
    "Bladder cancer",
    "FDA",
    "J&J"
  ],
  "summary": "In May 2025 the FDA would not even file ImmunityBio's application. On October 14, 2026, Anktiva won its papillary bladder cancer label 84 days early, no new trial. After a decade of BCG shortages, the FDA chose speed.",
  "key_points": [
    "On October 14, 2026, the FDA approved ImmunityBio's Anktiva with BCG for BCG-unresponsive non-muscle invasive bladder cancer with high-grade papillary-only tumors, 84 days before the January 6, 2027 review deadline, by extrapolating efficacy from the carcinoma in situ cohort (77 patients, 62% complete response) without a new randomized trial.",
    "The FDA had issued a refuse-to-file letter for the supplemental application in May 2025 and asked for a randomized trial against chemotherapy; in January 2026 ImmunityBio agreed a resubmission path requiring no new trial and filed long-term follow-up in 80 papillary patients (58.2% disease-free at 12 months, 81.8% cystectomy-free at 36 months).",
    "Anktiva's second-quarter 2026 net product revenue was $50.7 million, up 92% year over year and nearly tied with UroGen's Zusduri at $50.4 million; J&J's Inlexzo has an 82% complete response rate in carcinoma in situ without BCG, and CG Oncology expects to complete its cretostimogene BLA in the fourth quarter of 2026."
  ],
  "facts": [
    {
      "claim": "FDA approval of Anktiva for BCG-unresponsive papillary-only NMIBC",
      "value": "2026-10-14",
      "unit": "date",
      "as_of": "2026-10-14",
      "source": "https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-expanded-indication-nogapendekin-alfa-inbakicept-pmln-bcg-unresponsive-non-muscle"
    },
    {
      "claim": "Original PDUFA date for papillary sBLA",
      "value": "2027-01-06",
      "unit": "date",
      "as_of": "2026-08-04",
      "source": "https://www.biospace.com/press-releases/immunitybio-reports-record-q2-2026-net-product-revenue-of-50-7-million-up-92-year-over-year-first-half-revenue-up-121-to-94-8-million"
    },
    {
      "claim": "Days approval came before PDUFA date",
      "value": "84",
      "unit": "days",
      "as_of": "2026-10-14",
      "source": "https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-expanded-indication-nogapendekin-alfa-inbakicept-pmln-bcg-unresponsive-non-muscle"
    },
    {
      "claim": "CIS cohort (n=77) complete response rate",
      "value": 62,
      "unit": "%",
      "as_of": "2026-10-14",
      "source": "https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-expanded-indication-nogapendekin-alfa-inbakicept-pmln-bcg-unresponsive-non-muscle"
    },
    {
      "claim": "FDA refuse-to-file letter for papillary sBLA",
      "value": "2025-05",
      "unit": "month",
      "as_of": "2025-07-25",
      "source": "https://ir.immunitybio.com/node/10811"
    },
    {
      "claim": "Papillary cohort size",
      "value": 80,
      "unit": "patients",
      "as_of": "2026-01-21",
      "source": "https://pharmaphorum.com/news/immunitybio-rises-route-opens-broader-anktiva-label"
    },
    {
      "claim": "Papillary cohort 12-month disease-free survival",
      "value": 58.2,
      "unit": "%",
      "as_of": "2026-01-21",
      "source": "https://pharmaphorum.com/news/immunitybio-rises-route-opens-broader-anktiva-label"
    },
    {
      "claim": "Papillary cohort 36-month disease-specific survival",
      "value": 96,
      "unit": "%",
      "as_of": "2026-01-21",
      "source": "https://pharmaphorum.com/news/immunitybio-rises-route-opens-broader-anktiva-label"
    },
    {
      "claim": "Papillary cohort 36-month cystectomy-free survival",
      "value": 81.8,
      "unit": "%",
      "as_of": "2026-01-21",
      "source": "https://pharmaphorum.com/news/immunitybio-rises-route-opens-broader-anktiva-label"
    },
    {
      "claim": "Stock gain on Jan 2026 resubmission-path news",
      "value": "more than 17",
      "unit": "%",
      "as_of": "2026-01-21",
      "source": "https://pharmaphorum.com/news/immunitybio-rises-route-opens-broader-anktiva-label"
    },
    {
      "claim": "Anktiva Q2 2026 net product revenue",
      "value": 50.7,
      "unit": "USD million",
      "as_of": "2026-08-04",
      "source": "https://www.biospace.com/press-releases/immunitybio-reports-record-q2-2026-net-product-revenue-of-50-7-million-up-92-year-over-year-first-half-revenue-up-121-to-94-8-million"
    },
    {
      "claim": "Anktiva Q2 2025 net product revenue",
      "value": 26.4,
      "unit": "USD million",
      "as_of": "2026-08-04",
      "source": "https://www.biospace.com/press-releases/immunitybio-reports-record-q2-2026-net-product-revenue-of-50-7-million-up-92-year-over-year-first-half-revenue-up-121-to-94-8-million"
    },
    {
      "claim": "Anktiva Q2 2026 revenue growth YoY",
      "value": 92,
      "unit": "%",
      "as_of": "2026-08-04",
      "source": "https://www.biospace.com/press-releases/immunitybio-reports-record-q2-2026-net-product-revenue-of-50-7-million-up-92-year-over-year-first-half-revenue-up-121-to-94-8-million"
    },
    {
      "claim": "Anktiva H1 2026 net product revenue",
      "value": 94.8,
      "unit": "USD million",
      "as_of": "2026-08-04",
      "source": "https://www.biospace.com/press-releases/immunitybio-reports-record-q2-2026-net-product-revenue-of-50-7-million-up-92-year-over-year-first-half-revenue-up-121-to-94-8-million"
    },
    {
      "claim": "Anktiva FY2025 net product revenue",
      "value": 113,
      "unit": "USD million",
      "as_of": "2026-08-04",
      "source": "https://www.biospace.com/press-releases/immunitybio-reports-record-q2-2026-net-product-revenue-of-50-7-million-up-92-year-over-year-first-half-revenue-up-121-to-94-8-million"
    },
    {
      "claim": "ImmunityBio cash and marketable securities (2026-06-30)",
      "value": 357.4,
      "unit": "USD million",
      "as_of": "2026-06-30",
      "source": "https://www.biospace.com/press-releases/immunitybio-reports-record-q2-2026-net-product-revenue-of-50-7-million-up-92-year-over-year-first-half-revenue-up-121-to-94-8-million"
    },
    {
      "claim": "ImmunityBio H1 2026 cash used in operations",
      "value": 141.9,
      "unit": "USD million",
      "as_of": "2026-06-30",
      "source": "https://www.biospace.com/press-releases/immunitybio-reports-record-q2-2026-net-product-revenue-of-50-7-million-up-92-year-over-year-first-half-revenue-up-121-to-94-8-million"
    },
    {
      "claim": "IBRX stock gain year-to-date at Oct 14, 2026",
      "value": "more than 400",
      "unit": "%",
      "as_of": "2026-10-14",
      "source": "https://stocktwits.com/news-articles/markets/equity/ibrx-stock-rallies-after-fda-clears-broader-anktiva-use-in-bladder-cancer-months-ahead-of-deadline/cZxfvaYRBq0"
    },
    {
      "claim": "Inlexzo CIS complete response rate (n=83)",
      "value": 82,
      "unit": "%",
      "as_of": "2025-09-09",
      "source": "https://www.onclive.com/view/fda-approves-tar-200-in-bcg-unresponsive-nmibc-with-cis"
    },
    {
      "claim": "UroGen Zusduri Q2 2026 net product revenue",
      "value": 50.4,
      "unit": "USD million",
      "as_of": "2026-08-05",
      "source": "https://www.biospace.com/press-releases/urogen-reports-50-4-million-of-zusduri-revenue-and-provides-second-quarter-2026-financial-results-and-highlights"
    },
    {
      "claim": "Zusduri activated sites / prescribers (2026-06-30)",
      "value": "1,444 / 452",
      "unit": "sites / prescribers",
      "as_of": "2026-06-30",
      "source": "https://www.biospace.com/press-releases/urogen-reports-50-4-million-of-zusduri-revenue-and-provides-second-quarter-2026-financial-results-and-highlights"
    },
    {
      "claim": "CG Oncology BOND-003 24-month CR rate (46/110)",
      "value": 41.8,
      "unit": "%",
      "as_of": "2025-11-14",
      "source": "https://cgoncology.com/?p=234114"
    },
    {
      "claim": "CG Oncology cash (2026-06-30)",
      "value": 1,
      "unit": "USD billion",
      "as_of": "2026-06-30",
      "source": "https://www.biospace.com/press-releases/cg-oncology-reports-second-quarter-2026-financial-results-and-provides-business-updates"
    },
    {
      "claim": "ImmunityBio H1 2026 GAAP net loss / adjusted net loss",
      "value": "863.2 / 167.3",
      "unit": "USD million",
      "as_of": "2026-06-30",
      "source": "https://www.biospace.com/press-releases/immunitybio-reports-record-q2-2026-net-product-revenue-of-50-7-million-up-92-year-over-year-first-half-revenue-up-121-to-94-8-million"
    },
    {
      "claim": "UroGen Q2 2026 net loss / cash (2026-06-30)",
      "value": "14.4 / 108.0",
      "unit": "USD million",
      "as_of": "2026-06-30",
      "source": "https://www.biospace.com/press-releases/urogen-reports-50-4-million-of-zusduri-revenue-and-provides-second-quarter-2026-financial-results-and-highlights"
    }
  ],
  "sections": [
    "01｜A refusal letter that turned into an early approval",
    "02｜Anktiva does not kill cancer cells; it wakes up the killers",
    "03｜The best response rate is not Anktiva's: J&J hits 82% without BCG",
    "04｜Why the FDA accepted extrapolation: a decade without enough BCG",
    "05｜What 84 days are worth: about $557,000 a day",
    "References"
  ],
  "references": [
    {
      "title": "FDA approves expanded indication for nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer",
      "source": "U.S. FDA",
      "date": "2026-10-14",
      "url": "https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-expanded-indication-nogapendekin-alfa-inbakicept-pmln-bcg-unresponsive-non-muscle"
    },
    {
      "title": "IBRX Stock Rallies After FDA Clears Broader Anktiva Use In Bladder Cancer Months Ahead Of Deadline",
      "source": "Stocktwits",
      "date": "2026-10-14",
      "url": "https://stocktwits.com/news-articles/markets/equity/ibrx-stock-rallies-after-fda-clears-broader-anktiva-use-in-bladder-cancer-months-ahead-of-deadline/cZxfvaYRBq0"
    },
    {
      "title": "ImmunityBio Reports Record Q2 2026 Net Product Revenue of $50.7 Million",
      "source": "ImmunityBio/BioSpace",
      "date": "2026-08-04",
      "url": "https://www.biospace.com/press-releases/immunitybio-reports-record-q2-2026-net-product-revenue-of-50-7-million-up-92-year-over-year-first-half-revenue-up-121-to-94-8-million"
    },
    {
      "title": "ImmunityBio Reports 60% Increase in Revenue in Q2 2025 (refuse-to-file update",
      "source": "ImmunityBio",
      "date": "2025-07-25",
      "url": "https://ir.immunitybio.com/node/10811"
    },
    {
      "title": "ImmunityBio rises as route opens to broader Anktiva label",
      "source": "pharmaphorum",
      "date": "2026-01-21",
      "url": "https://pharmaphorum.com/news/immunitybio-rises-route-opens-broader-anktiva-label"
    },
    {
      "title": "Patrick Soon-Shiong",
      "source": "Wikipedia",
      "date": "2026-10-17",
      "url": "https://en.wikipedia.org/wiki/Patrick_Soon-Shiong"
    },
    {
      "title": "FDA Approves TAR-200 in BCG-Unresponsive NMIBC With CIS",
      "source": "OncLive",
      "date": "2025-09-09",
      "url": "https://www.onclive.com/view/fda-approves-tar-200-in-bcg-unresponsive-nmibc-with-cis"
    },
    {
      "title": "UroGen Reports $50.4 Million of ZUSDURI Revenue and Provides Second Quarter 2026 Financial Results",
      "source": "UroGen/BioSpace",
      "date": "2026-08-05",
      "url": "https://www.biospace.com/press-releases/urogen-reports-50-4-million-of-zusduri-revenue-and-provides-second-quarter-2026-financial-results-and-highlights"
    },
    {
      "title": "CG Oncology Reports Third Quarter 2025 Financial Results",
      "source": "CG Oncology",
      "date": "2025-11-14",
      "url": "https://cgoncology.com/?p=234114"
    },
    {
      "title": "CG Oncology Reports Second Quarter 2026 Financial Results and Provides Business Updates",
      "source": "CG Oncology/BioSpace",
      "date": "2026-08-06",
      "url": "https://www.biospace.com/press-releases/cg-oncology-reports-second-quarter-2026-financial-results-and-provides-business-updates"
    },
    {
      "title": "BCG Shortage: Key Facts for Bladder Cancer Patients & Families",
      "source": "BCAN",
      "date": "2026-10-17",
      "url": "https://bcan.org/bcg-shortage-bladder-cancer/"
    },
    {
      "title": "ImmunityBio Signs Exclusive U.S. Agreement with Japan BCG Laboratory for the Tokyo Strain of BCG",
      "source": "ImmunityBio/BioSpace",
      "date": "2026-05-17",
      "url": "https://www.biospace.com/press-releases/immunitybio-signs-exclusive-u-s-agreement-with-japan-bcg-laboratory-for-the-tokyo-strain-of-bcg-to-enhance-bcg-supply-in-the-united-states"
    }
  ],
  "images": [
    {
      "alt": "Figure 1｜From refusal to early approval, with no new randomized trial in between",
      "url": "https://drugnews.com.tw/assets/articles/immunitybio-anktiva-papillary-early-approval-en/figure-01.png"
    },
    {
      "alt": "Figure 2｜Four bladder cancer drugs, four points of attack",
      "url": "https://drugnews.com.tw/assets/articles/immunitybio-anktiva-papillary-early-approval-en/figure-02.png"
    },
    {
      "alt": "Figure 3｜Second-quarter revenue: Anktiva and Zusduri almost tied",
      "url": "https://drugnews.com.tw/assets/articles/immunitybio-anktiva-papillary-early-approval-en/figure-03.png"
    }
  ],
  "cover_image": "https://drugnews.com.tw/assets/articles/immunitybio-anktiva-papillary-early-approval-en/cover.png",
  "publisher": {
    "name": "Drugnews｜藥時事",
    "url": "https://drugnews.com.tw/",
    "profile": "https://drugnews.com.tw/brand-profile.json"
  },
  "citation": "Drugnews｜藥時事（2026-10-18）。Soon-Shiong Beats the FDA Clock on Anktiva。https://drugnews.com.tw/articles/2026-10-18-immunitybio-anktiva-papillary-early-approval-en.html",
  "disclaimer": "This article is intended for industry research and knowledge sharing only. It does not constitute investment, medical, fundraising, or individual stock advice.",
  "translations": {}
}