ASCO Warns of Critical Ifosfamide Shortage Threatening Cancer Treatment
核心洞察
ASCO and the Association for Clinical Oncology issued a critical drug supply warning after members reported severe disruptions to ifosfamide (Ifex) supply, with some practices holding less than a few weeks of inventory.
The shortage stems from a Baxter (搜索)-contracted manufacturer in Germany halting production due to inspection-related issues, while alternate manufacturers Fresenius Kabi and Hikma (搜索) have placed products on allocation.
No direct substitute exists for ifosfamide, which is used most often in pediatric sarcoma (搜索), testicular cancer (搜索), and lymphoma (搜索), and the shortage may persist until at least October 2026.
The American Society of Clinical Oncology (ASCO) and the Association for Clinical Oncology have issued a critical drug supply warning after members reported severe disruptions to the ifosfamide (Ifex) supply, with some practices holding less than a few weeks of inventory, according to a news release from ASCO. No direct substitute exists for the chemotherapy agent, and the organizations are urging practices to review federal shortage-mitigation guidance while supply remains constrained.
ASCO has directed practices to the Department of Health and Human Services' Administration for Strategic Preparedness and Response (ASPR) TRACIE Coordinating Resources for Emergency Supply-related Treatment Strategies (CRESTS) considerations document for waste-minimization strategies during the shortage.
What Is Driving the Shortage
The shortage stems from a Baxter (搜索)-contracted manufacturer in Germany halting production because of inspection-related issues, affecting both Ifex and generic ifosfamide powder for injection in 1 g and 3 g single-count vials. Fresenius Kabi and Hikma (搜索), the two alternate manufacturers, have placed their ifosfamide products on allocation because of increased demand but are not expected to produce enough supply to meet typical use in the coming weeks.
The shortage may persist until at least October 2026, according to the CRESTS document, although the timeline for resumption of full production from the affected manufacturer remains unclear.
Affected Product Forms
The production suspension and allocation measures affect multiple presentations of ifosfamide. Baxter (搜索)'s Ifex powder for solution for injection in 1 gram and 3 gram single-count vials, as well as generic ifosfamide powder for solution for injection in 1 gram and 3 gram vials, have been halted due to production suspension. Fresenius Kabi's ifosfamide lyophilized powder for injection (1 gram, single vial) and Hikma (搜索)'s ifosfamide injection (50 mg/mL in 20 mL and 60 mL vials) have been placed on allocation due to increased demand.
Regulatory Response
The FDA is planning to temporarily allow importation of ifosfamide from overseas manufacturers that do not typically supply the US market to help bolster domestic supply, according to ASCO. The agency continues to explore temporary licensing of additional internationally manufactured product for use in the US as the shortage continues.
Recommended Mitigation Strategies
The CRESTS document outlines supply, substitution, and conservation strategies organized into a three-tier, risk-based system intended to help institutions apply proportional restrictions as a shortage worsens.
Recommended supply strategies include rounding doses down to avoid opening a new vial for a fractional amount, vial-splitting or aliquoting in large centers with appropriate cleanroom preparation, and regional coordination to move doses between patients or facilities. Because ifosfamide is weight- or body surface area–dosed and typically given across multiple cycles, the document also recommends against significant dose reduction and advises that chemotherapy with a high likelihood of benefit should not be delayed in anticipation of further shortage.
If regional coordination fails to maintain standard treatment, the guidance recommends conservation strategies such as prioritizing potentially curative treatment, pausing enrollment in research protocols involving ifosfamide, and restricting use to conditions with high curative potential, including selected salvage treatment in the most severe shortage tier.
Clinical Impact
Ifosfamide is used most often in the treatment of pediatric sarcoma (搜索), along with testicular cancer (搜索) and lymphoma (搜索), according to the CRESTS considerations document. The guidance provides diagnosis-specific allocation considerations for sarcoma, lymphoma, neuroblastoma (搜索), and testicular germ cell tumors, recommending that clinicians consider non-ifosfamide regimens or alternate agents such as cyclophosphamide, bleomycin, or doxorubicin where clinically appropriate before restricting use further.
In the most severe shortage tier, the document suggests reserving ifosfamide for highly responsive tumors such as Ewing sarcoma (搜索) and for initial treatment of Hodgkin and non-Hodgkin lymphoma (搜索).