'FDA commissioner heralds end to US shortfall of chemo drug cisplatin'

 Stocks of cisplatin are now able to meet demand for the widely used chemotherapy drug that had been in short supply in the U.S. over the last year, the FDA's top official said.

FDA Commissioner Robert Califf, M.D., announced Friday on social media that the cisplatin drug shortage was over. The agency had previously said it would continue to work with drugmakers and other interested parties to address shortages of cancer treatments.

“I am pleased to share that the national supply of cisplatin now exceeds demand, ending the national shortage for this important cancer drug,” Califf said on X (formerly Twitter).

In June 2023, the National Comprehensive Cancer Network (NCCN) Best Practices Committee released a survey that found 70% of member treatment centers were experiencing a cisplatin shortage. Almost all were experiencing carboplatin shortfalls at the time.

In a new survey released by the NCCN last Thursday, the group said only 11% of surveyed centers reported a shortage of carboplatin and 7% for cisplatin. However, new concerns about supplies have emerged, according to the group.

“Critical drug shortages were not a new problem last year and they continue to be a problem now,” Crystal Denlinger, M.D., NCCN’s chief executive, said in a statement. “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.”

The NCCN's latest survey found shortages were impacting clinical trials at 43% of centers surveyed, creating budgeting and enrollment challenges as well as producing heavier administrative burdens.

NCCN conducted its latest survey between May 28 and June 11. 

Last year, in response to the shortages, the FDA cleared cisplatin to be imported to the U.S. from Chinese manufacturer Qilu Pharmaceutical as well as allowed India’s Intas Pharmaceuticals to resume shipping cisplatin, carboplatin and 14 other injectables to the U.S.

The agency said at the time that it was working closely with five generics manufacturers to boost supplies of another cancer drug, methotrexate.

The shortages were triggered by a combination of several generic drug makers discontinuing manufacture of some products due to “economic reasons" along with the closure of production sites that resulted in the U.S. supply of cisplatin, carboplatin and methotrexate being cut nearly in half.

https://www.fiercepharma.com/manufacturing/fda-heralds-end-us-shortfall-chemo-drug-cisplatin