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Other antitumour antibioticsIn useNatural productNeeds review

Mitomycin

Also known as Mitomycin C, Mutamycin, Jelmyto, Zusduri

An antibiotic from Streptomyces caespitosus that cross-links DNA. The generic injection's US label lists disseminated stomach or pancreatic adenocarcinoma; separate formulations are approved for low-grade urothelial cancers.

From discovery to approval

  1. 1956 · Earliest report found

    Hata and colleagues described mitomycin as a new antibiotic from Streptomyces in 1956, in two papers (part I, and a description of the strain) cited by title only; they do not say which mitomycin. A 2009 review says the mitomycins form during cultivation of Streptomyces caespitosus, as the US label also states.[2][3][4][5]

  2. 2020-04-15 · FDA regular

    Mitomycin for pyelocalyceal solution (Jelmyto), NDA 211728, for adult patients with low-grade upper tract urothelial cancer. This is a new formulation of mitomycin, not the original approval of the injection. The letter has no accelerated-approval wording; the type regular is an inference.[6]

  3. 2025-06-12 · FDA regular

    Mitomycin for intravesical solution (Zusduri), NDA 215793, for adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. This is a new formulation of mitomycin, not the original approval of the injection. The letter has no accelerated-approval wording; the type regular is an inference.[7]

How it works

A review says it cross-links DNA with high efficiency and absolute specificity for the sequence CpG. The injection label says it selectively inhibits DNA synthesis, with cross-linking correlating to the guanine and cytosine content.[1]

Where it came from and why

The 1956 titles describe a new antibiotic, and the label calls the drug an antibiotic shown to have antitumour activity. The papers cited do not state why it was tested against cancer.

Cancers

  • Gastric and pancreatic cancer

    The injection label lists disseminated adenocarcinoma of the stomach or pancreas in proven combinations with other chemotherapy and as palliative treatment when other modalities have failed. It is not recommended as single-agent primary therapy.[5]

  • Anal canal cancer

    In a phase III trial of 291 assessable patients, adding mitomycin to fluorouracil and radiotherapy lowered colostomy rates (9% against 22%) and raised 4-year disease-free survival (73% against 51%), with more grade 4 and 5 toxicity (23% against 7%); no significant overall survival difference had been observed at 4 years.[8]

  • Upper tract urothelial cancer

    The FDA approved Jelmyto (mitomycin for pyelocalyceal solution) on 15 April 2020 for adult patients with low-grade upper tract urothelial cancer.[6]

  • Non-muscle invasive bladder cancer

    The FDA approved Zusduri (mitomycin for intravesical solution) on 12 June 2025 for adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer.[7]

Worth knowing

  • The Drugs@FDA page for the original Mutamycin application (NDA 050450) lists the products as discontinued and shows no original approval date.[9]
  • A 2009 review gives 1974 as the year of FDA approval of mitomycin C, a date the Drugs@FDA page for the Mutamycin application does not show.[4]
  • A 2001 clinical update concluded that mitomycin C has a definite place in localized bladder cancer but is being displaced by other drugs in cervical, gastric and pancreatic cancers, and is probably no longer of therapeutic value in colon cancer.[10]

On this site

References

  1. Tomasz M. Mitomycin C: small, fast and deadly (but very selective). Chem Biol. 1995;2(9):575-9. PubMedDOI
  2. HATA T, HOSHI T, KANAMORI K, MATSUMAE A, SANO Y, SHIMA T, et al. Mitomycin, a new antibiotic from Streptomyces. I. J Antibiot (Tokyo). 1956;9(4):141-6. PubMed
  3. HATA T, SUGAWARA R. Mitomycin, a new antibiotic from Streptomyces. II. Description of the strain. J Antibiot (Tokyo). 1956;9(4):147-51. PubMed
  4. Demain AL, Sanchez S. Microbial drug discovery: 80 years of progress. J Antibiot (Tokyo). 2009;62(1):5-16. PubMedDOI
  5. DailyMed. Mitomycin for injection, Hikma Pharmaceuticals USA Inc., SPL set id 5917f7a7-cd20-407b-8dda-9fd58c5f47a6, version 5, effective 29 May 2026 (text read through the openFDA drug label API). Source
  6. U.S. Food and Drug Administration. NDA approval letter, NDA 211728, Jelmyto (mitomycin) for pyelocalyceal solution, UroGen Pharma; electronic signature 15 April 2020. Source
  7. U.S. Food and Drug Administration. NDA approval letter, NDA 215793, mitomycin for intravesical solution (Zusduri), recurrent low-grade intermediate-risk non-muscle invasive bladder cancer; electronic signature 12 June 2025. Letter text read 21 October 2026. Source
  8. Flam M, John M, Pajak TF, Petrelli N, Myerson R, Doggett S, et al. Role of mitomycin in combination with fluorouracil and radiotherapy, and of salvage chemoradiation in the definitive nonsurgical treatment of epidermoid carcinoma of the anal canal: results of a phase III randomized intergroup study. J Clin Oncol. 1996;14(9):2527-39. PubMedDOI
  9. U.S. Food and Drug Administration. Drugs@FDA: NDA 050450 (Mutamycin, mitomycin; Bristol). Page read 2026-10-29; it lists the products and their marketing status but shows no approval history. Source
  10. Bradner WT. Mitomycin C: a clinical update. Cancer Treat Rev. 2001;27(1):35-50. PubMedDOI
  11. U.S. Food and Drug Administration. Drugs@FDA: Approval date(s) and history, letters, labels, reviews for NDA 211728 (Jelmyto, mitomycin for pyelocalyceal solution). Page read 2026-10-29. Source