MedPath

Mitomycins

Generic Name
Mitomycins
Brand Names
Jelmyto, Mitosol, Mutamycin
Drug Type
Small Molecule
Chemical Formula
C15H18N4O5
CAS Number
50-07-7
Unique Ingredient Identifier
50SG953SK6

Overview

Mitomycin is an antineoplastic antibiotic first isolated by Japanese microbiologists in the 1950s from cultures of Streptomyces caespitosus. It is an alkylating agent that inhibits DNA synthesis (and, at higher concentrations, RNA and protein synthesis) by cross-linking the complementary strands of the DNA double helix. Few other antibiotics have been discovered that work via this alkylating mechanism, making mitomycin relatively unique in the space of microbiota-derived therapies. Mitomycin's cross-linking activity has resulted in its approval for the treatment of a variety of cancers - the most recent of which is an April 2020 approval for its use in low-grade Upper Tract Urothelial Cancer (LG-UTUC) - as well as adjunctly to ab externo glaucoma surgeries.

Background

Mitomycin is an antineoplastic antibiotic first isolated by Japanese microbiologists in the 1950s from cultures of Streptomyces caespitosus. It is an alkylating agent that inhibits DNA synthesis (and, at higher concentrations, RNA and protein synthesis) by cross-linking the complementary strands of the DNA double helix. Few other antibiotics have been discovered that work via this alkylating mechanism, making mitomycin relatively unique in the space of microbiota-derived therapies. Mitomycin's cross-linking activity has resulted in its approval for the treatment of a variety of cancers - the most recent of which is an April 2020 approval for its use in low-grade Upper Tract Urothelial Cancer (LG-UTUC) - as well as adjunctly to ab externo glaucoma surgeries.

Indication

For treatment of malignant neoplasm of lip, oral cavity, pharynx, digestive organs, peritoneum, female breast, and urinary bladder. Also used as an adjunct to ab externo glaucoma surgery. Mitomycin is also indicated as a pyelocalyceal solution for the treatment of adults with low-grade upper tract urothelial cancer (LG-UTUC).

Associated Conditions

  • Anal Cancer
  • Bladder Cancer
  • Breast Cancer
  • Carcinoma of the Head and Neck
  • Cervical Cancer
  • Gastric Adenocarcinoma
  • Mesothelioma
  • Non-Small Cell Lung Cancer (NSCLC)
  • Pancreatic Adenocarcinoma
  • Ab externo surgery Glaucoma
  • Low-grade Upper Tract Urothelial Cancer (LG-UTUC)

FDA Approved Products

Mitomycin
Manufacturer:BluePoint Laboratories
Route:INTRAVENOUS
Strength:40 mg in 80 mL
Approved: 2021/06/09
NDC:68001-391
Mitomycin
Manufacturer:Accord Healthcare Inc
Route:INTRAVENOUS
Strength:5 mg in 10 mL
Approved: 2023/08/22
NDC:16729-115
Mitomycin
Manufacturer:Sagent Pharmaceuticals
Route:INTRAVENOUS
Strength:5 mg in 10 mL
Approved: 2023/05/24
NDC:25021-250
Mitomycin
Manufacturer:Accord Healthcare Inc
Route:INTRAVENOUS
Strength:20 mg in 40 mL
Approved: 2023/08/22
NDC:16729-108
MITOMYCIN
Manufacturer:Gland Pharma Limited
Route:INTRAVENOUS
Strength:40 mg in 80 mL
Approved: 2022/11/23
NDC:68083-502

Singapore Approved Products

No Singapore products found for this drug

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