FDA marks cisplatin drug shortage as resolved

Data recently published by the NCCN illustrate changes in the cancer drug shortage over the past year.

The FDA has classified the cisplatin drug shortage as resolved, determining that the supply of the chemotherapy drug now exceeds demand, the agency announced in a news release.^1,2

This announcement marks the end of the national shortage for cisplatin, which was first announced on February 10, 2023.

Since then, the FDA has taken several steps to alleviate the drug shortage, including,

• “Working closely with 5 cancer drug manufacturers to provide assistance and support their efforts to increase manufacturing capacity.
• Helping another manufacturer who had previously stopped producing an approved cisplatin product reenter the market.
• Temporarily exercising discretion not to enforce importation requirements with regard to cisplatin to help meet patient needs during the shortage. As with all temporary importation, the product and manufacturing sites were thoroughly evaluated to help protect U.S. patients. That manufacturer has since received FDA approval for cisplatin, bringing the total number of approved manufacturers to 7,” according to the news release.¹

Data recently published by the National Comprehensive Cancer Center (NCCN) illustrate changes in the cancer drug shortage over the past year. Findings showed that 70% of centers were lacking an adequate supply of cisplatin during the shortage in June 2023, compared with only 7% of centers in the latest survey (June 2024).³

Similarly, although the chemotherapy drug carboplatin still remains in shortage, the number of centers reporting a lack of the drug decreased from 93% at the peak of the shortage in June 2023 to 11% in June 2024.

However, despite these strides, concerns surrounding cancer drug shortages remain. The survey also showed that 89% of centers are still experiencing shortages for at least 1 type of systemic therapy, and 75% are experiencing shortages for 2 or more drugs. These shortages were found to impact clinical trials at 43% of centers, with effects on budgeting, enrollment, and increased administrative burden. Additionally, 27% of centers cited that shortage-related changes that required additional prior authorization resulted in treatment delays.

"Critical drug shortages were not a new problem last year and they continue to be a problem now," explained Crystal S. Denlinger, MD, CEO of the NCCN, in the news release.³ "The dual carboplatin and cisplatin shortage was particularly severe, and we were able to help sound the alarm during its peak. Despite a renewed attention to drug shortages over the past year, 89% of the responding centers in the latest survey are still reporting shortages of various important anti-cancer agents and supportive care medications. Most of them are still managing shortages for more than 1 type of medication right now. These shortages not only put a burden on patients, caregivers, and providers, but they could also delay vital clinical trials and slow the pace of progress for new cancer therapies."

The FDA noted plans to continue working with manufacturers and health care providers to restore access to other cancer drugs that remain in short supply.¹

References

1. FDA Roundup: June 28, 2024. News release. US Food & Drug Administration. June 28, 2024. Accessed July 9, 2024. https://www.fda.gov/news-events/press-announcements/fda-roundup-june-28-2024

2. FDA Drug Shortages. US Food & Drug Administration. Accessed July 9, 2024. https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Cisplatin%20Injection&st=r&tab=tabs-1

3. New survey from NCCN finds cancer drug shortage management remains a moving target, impacting clinical trials. News release. National Comprehensive Cancer Center. June 26, 2024. Accessed July 9, 2024. https://www.nccn.org/home/news/newsdetails?NewsId=4620