ASCO Warns of Critical Ifosfamide Shortage Threatening Cancer Treatment

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.¹ 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.²

What is driving the ifosfamide shortage?

The shortage stems from a Baxter-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, the 2 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.

Which product forms are affected?

Ifex power for solution for injection, 1 gram, vial, 1 count – produced by Baxter – halted due to production suspension

1. Ifex power for solution for injection, 3 grams, vial, 1 count – produced by Baxter – halted due to production suspension
2. Ifosfamide powder for solution for injection – 1 gram, vial, 1 count– produced by Baxter – halted due to production suspension
3. Ifex power for solution for injection, 3 grams, vial, 1 count – produced by Baxter – halted due to production suspension
4. Ifosfamide lyophilized powder for injection – 1 gram, 1 vial, 1 count – produced by Fresenius Kabi – allocation due to increased demand
5. Ifosfamide injection – 50 mg/mL, 20 mL vial – produced by Hikma – allocation due to increased demand
6. Ifosfamide injection – 50 mg/mL, 60 mL vial – produced by Hikma – allocation due to increased demand

What is the FDA doing about the shortage?

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.

What mitigation strategies are recommended during the shortage?

The CRESTS document outlines supply, substitution, and conservation strategies organized into a 3-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.

Which cancers are most affected by the shortage?

Ifosfamide is used most often in the treatment of pediatric sarcoma, along with testicular cancer and lymphoma, according to the CRESTS considerations document. The guidance provides diagnosis-specific allocation considerations for sarcoma, lymphoma, neuroblastoma, 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 and for initial treatment of Hodgkin and non-Hodgkin lymphoma.

References

1. Critical drug supply warning: US ifosfamide shortage. News release. ASCO. August 25, 2026. Accessed August 27, 2026. https://tinyurl.com/4d23hfpt
2. Ifosfamide shortage strategies, version 2. Coordinating Resources for Emergency Supply-related Treatment Strategies (CRESTS). Administration for Strategic Preparedness and Response TRACIE. July 7, 2026. Accessed August 27, 2026. https://tinyurl.com/3b2pzh77