The American Society of Clinical Oncology (ASCO has issued a warning regarding critical supply disruptions affecting the availability of ifosfamide, an alkylating agent for which no direct therapeutic substitute is available, according to an alert from the society, which also outlined that some oncology practices have reported on-hand inventory of the agent sufficient for less than a few weeks.1
The FDA first added ifosfamide injection to its drug shortage database on June 12, 2026, and continues to list the product as in shortage.2 The agency has attributed the disruption to good manufacturing practice compliance requirements in the production of the product by Baxter Healthcare, along with increased demand affecting Fresenius Kabi USA and Hikma Pharmaceuticals USA.
As of early August 2026, Baxter listed all 4 of its ifosfamide presentations as unavailable, with estimated recovery in September to October 2026; Fresenius Kabi listed its 1-g presentation as unavailable ahead of an anticipated August 2026 release; and Hikma reported 1 presentation available with additional manufacturing planned.2
Ifosfamide is approved by the FDA for the treatment of malignant germ cell testicular cancer, in combination with other antineoplastic agents, in patients who have already received at least 2 prior chemotherapy regimens.3 The alkylating agent is typically administered with the uroprotectant mesna to reduce the risk of hemorrhagic cystitis.
Although its labeled indication is narrow, ifosfamide is incorporated into multiagent regimens across several additional tumor types.
Beyond its labeled indication, ifosfamide is a component of standard multiagent regimens for bone and soft tissue sarcomas, and real-world analyses document its ongoing use in that setting.4 In a single-center retrospective cohort of 80 patients with advanced soft tissue or bone sarcoma who had received a median of 3 to 4 prior lines of therapy, continuous-infusion ifosfamide yielded a disease control rate of 50% in soft tissue sarcoma, including 80% among patients with synovial sarcoma, and a median overall survival of 13.0 months.
Coordinated, subtype-specific systemic therapy delivered by a dedicated multidisciplinary team remains central to sarcoma management, and cytotoxic agents such as ifosfamide continue to underpin those regimens.5 The breadth of these uses means that a testicular cancer label understates the number of patients affected when the agent becomes scarce.
ASCO has directed practices navigating the ifosfamide shortage to its Drug Shortages Resource Center, which compiles clinical mitigation guidance, dose-rounding protocols, and FDA updates, and has pointed clinicians to waste-minimization strategies from the HHS TRACIE program and to guidance from the American Society of Health-System Pharmacists.1,6 The FDA has indicated that it plans to temporarily authorize importation of ifosfamide from overseas manufacturers that do not ordinarily supply the US market, a mechanism the agency has used to relieve prior shortages of essential oncology agents.1
ASCO has noted that the medical community has experienced more than a decade of recurring drug shortages, including shortages of critical frontline cancer drugs.6
