FDA Approval Summary: Nogapendekin Alfa Inbakicept-pmln with BCG for BCG-Unresponsive Carcinoma In Situ Article Swipe
Brian L. Heiss
,
Elaine Chang
,
Hee‐Koung Joeng
,
Mallorie H. Fiero
,
Lingshan Wang
,
Salaheldin S. Hamed
,
Haw-Jyh Chiu
,
Tiffany K. Ricks
,
Eun Ha Koh
,
Teegan A. Dellibovi-Ragheb
,
Min Wang
,
Christal Lee
,
William F. Pierce
,
John K. Leighton
,
Nam Atiqur Rahman
,
Shenghui Tang
,
Richard Pazdur
,
Laleh Amiri‐Kordestani
,
Paul G. Kluetz
,
Daniel L. Suzman
·
YOU?
·
· 2025
· Open Access
·
· DOI: https://doi.org/10.1158/1078-0432.ccr-25-1231
YOU?
·
· 2025
· Open Access
·
· DOI: https://doi.org/10.1158/1078-0432.ccr-25-1231
On April 22, 2024, the U.S. FDA granted regular approval to nogapendekin alfa inbakicept-pmln (N-803) with Bacillus Calmette-Guerin (BCG) for the treatment of adult patients with BCG-unresponsive non–muscle-invasive bladder cancer with carcinoma in situ, with or without papillary tumors. Substantial evidence of effectiveness for this application was obtained from cohort A of the single-arm, multicenter QUILT-3.032 trial. Patients received N-803 400 μg administered intravesically with TICE BCG once a week for 6 weeks as induction therapy, a second induction course if complete response (CR) was not achieved at month 3, and maintenance N-803 with BCG weekly for 3 weeks at months 4, 7, 10, 13, and 19 (for a total of 15 maintenance doses). The major efficacy outcome measures were CR at any time [as defined by negative results for cystoscopy [with transurethral resection of bladder tumor (TURBT)/biopsies as applicable] per local investigator assessment and urine cytology] and duration of response. The CR rate in the 77-patient efficacy population, per FDA review, was 62% [95% confidence interval (CI), 51%–73%]. Of the 48 patients with a CR, 28 (58%; 95% CI, 26%–55%) and 19 (40%; 95% CI, 16%–36%) maintained a response for ≥12 months and ≥24 months, respectively. The most common adverse reactions were increased creatinine, dysuria, hematuria, urinary frequency, urinary urgency, and urinary tract infection. This article summarizes the data and FDA thought process supporting the approval of N-803 with BCG.
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Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1158/1078-0432.ccr-25-1231
- OA Status
- green
- References
- 11
- Related Works
- 10
- OpenAlex ID
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All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4413279695Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.1158/1078-0432.ccr-25-1231Digital Object Identifier
- Title
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FDA Approval Summary: Nogapendekin Alfa Inbakicept-pmln with BCG for BCG-Unresponsive Carcinoma In SituWork title
- Type
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articleOpenAlex work type
- Language
-
enPrimary language
- Publication year
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2025Year of publication
- Publication date
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2025-08-18Full publication date if available
- Authors
-
Brian L. Heiss, Elaine Chang, Hee‐Koung Joeng, Mallorie H. Fiero, Lingshan Wang, Salaheldin S. Hamed, Haw-Jyh Chiu, Tiffany K. Ricks, Eun Ha Koh, Teegan A. Dellibovi-Ragheb, Min Wang, Christal Lee, William F. Pierce, John K. Leighton, Nam Atiqur Rahman, Shenghui Tang, Richard Pazdur, Laleh Amiri‐Kordestani, Paul G. Kluetz, Daniel L. SuzmanList of authors in order
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https://doi.org/10.1158/1078-0432.ccr-25-1231Publisher landing page
- Open access
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YesWhether a free full text is available
- OA status
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greenOpen access status per OpenAlex
- OA URL
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https://www.ncbi.nlm.nih.gov/pmc/articles/12363661Direct OA link when available
- Concepts
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Medicine, Cystoscopy, Carcinoma in situ, Bladder cancer, Population, Dysuria, Urinary system, Adverse effect, Surgery, Internal medicine, Urology, Cancer, Environmental healthTop concepts (fields/topics) attached by OpenAlex
- Cited by
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0Total citation count in OpenAlex
- References (count)
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11Number of works referenced by this work
- Related works (count)
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10Other works algorithmically related by OpenAlex
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| abstract_inverted_index.response | 83, 190 |
| abstract_inverted_index.therapy, | 76 |
| abstract_inverted_index.urgency, | 211 |
| abstract_inverted_index.carcinoma | 32 |
| abstract_inverted_index.cytology] | 147 |
| abstract_inverted_index.increased | 204 |
| abstract_inverted_index.induction | 75, 79 |
| abstract_inverted_index.papillary | 38 |
| abstract_inverted_index.reactions | 202 |
| abstract_inverted_index.resection | 134 |
| abstract_inverted_index.response. | 151 |
| abstract_inverted_index.treatment | 22 |
| abstract_inverted_index.16%–36%) | 187 |
| abstract_inverted_index.26%–55%) | 181 |
| abstract_inverted_index.77-patient | 157 |
| abstract_inverted_index.assessment | 144 |
| abstract_inverted_index.confidence | 166 |
| abstract_inverted_index.cystoscopy | 131 |
| abstract_inverted_index.frequency, | 209 |
| abstract_inverted_index.hematuria, | 207 |
| abstract_inverted_index.infection. | 215 |
| abstract_inverted_index.maintained | 188 |
| abstract_inverted_index.summarizes | 218 |
| abstract_inverted_index.supporting | 225 |
| abstract_inverted_index.51%–73%]. | 169 |
| abstract_inverted_index.QUILT-3.032 | 56 |
| abstract_inverted_index.Substantial | 40 |
| abstract_inverted_index.applicable] | 140 |
| abstract_inverted_index.application | 46 |
| abstract_inverted_index.creatinine, | 205 |
| abstract_inverted_index.maintenance | 92, 113 |
| abstract_inverted_index.multicenter | 55 |
| abstract_inverted_index.population, | 159 |
| abstract_inverted_index.single-arm, | 54 |
| abstract_inverted_index.administered | 63 |
| abstract_inverted_index.investigator | 143 |
| abstract_inverted_index.nogapendekin | 12 |
| abstract_inverted_index.effectiveness | 43 |
| abstract_inverted_index.respectively. | 197 |
| abstract_inverted_index.transurethral | 133 |
| abstract_inverted_index.intravesically | 64 |
| abstract_inverted_index.Calmette-Guerin | 18 |
| abstract_inverted_index.inbakicept-pmln | 14 |
| abstract_inverted_index.(TURBT)/biopsies | 138 |
| abstract_inverted_index.BCG-unresponsive | 27 |
| abstract_inverted_index.non–muscle-invasive | 28 |
| cited_by_percentile_year | |
| countries_distinct_count | 2 |
| institutions_distinct_count | 20 |
| sustainable_development_goals[0].id | https://metadata.un.org/sdg/3 |
| sustainable_development_goals[0].score | 0.7300000190734863 |
| sustainable_development_goals[0].display_name | Good health and well-being |
| citation_normalized_percentile.value | 0.52729271 |
| citation_normalized_percentile.is_in_top_1_percent | False |
| citation_normalized_percentile.is_in_top_10_percent | True |