Last reviewed 2026-04-20 · How we verify

Mitozytrex (MITOMYCIN)

Mitozytrex, developed by Kyowa Kirin Co., Ltd., is a marketed alkylating agent indicated for disseminated adenocarcinoma of the stomach or pancreas. Its key strength lies in its mechanism of action, which effectively interferes with DNA replication in cancer cells, setting it apart in the treatment landscape. The primary risk is the upcoming key patent expiry in 2028, which could lead to increased competition from generics.

At a glance

Approved indications

• Disseminated adenocarcinoma of the stomach or pancreas
• Palliative treatment for disseminated adenocarcinoma

Boxed warnings

• WARNING Mitomycin should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of therapy and complications is possible only when adequate diagnostic and treatment facilities are readily available. Bone marrow suppression, notably thrombocytopenia and leukopenia, which may contribute to overwhelming infections in an already compromised patient, is the most common and severe of the toxic effects of mitomycin (see WARNINGS and ADVERSE REACTIONS sections). Hemolytic Uremic Syndrome (HUS) a serious complication of chemotherapy, consisting primarily of microangiopathic hemolytic anemia, thrombocytopenia, and irreversible renal failure has been reported in patients receiving systemic mitomycin. The syndrome may occur at any time during systemic therapy with mitomycin as a single agent or in combination with other cytotoxic drugs, however, most cases occur at doses ≥60 mg of mitomycin. Blood product transfusion may exacerbate the symptoms associated with this syndrome. The incidence of the syndrome has not been defined.

Common side effects

• Bone Marrow Toxicity
• Integument and Mucous Membrane Toxicity
• Renal Toxicity

Key clinical trials

• Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer (PHASE2)
• Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies (PHASE1)
• Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to Radiation Therapy Compared to the Usual Chemotherapy Treatment During Radiation Therapy for Bladder Cancer, PARRC Trial (PHASE2)
• Preserflo MicroShunt Versus Trabeculectomy (NA)
• Chemoradiotherapy With or Without Atezolizumab in Treating Patients With Localized Muscle Invasive Bladder Cancer (PHASE3)
• Perioperative Systemic Therapy for Isolated Resectable Colorectal Peritoneal Metastases (PHASE2,PHASE3)
• Safety and Efficacy of PIPAC Using Single Agent Mitomycin in Solid Tumors (PHASE1)
• Lower-Dose Chemoradiation in Treating Patients With Early-Stage Anal Cancer, the DECREASE Study (PHASE2)

Patents

Primary sources

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