Cisplatin Imports From China Are Aiding in Alleviating U.S. Chemo Shortage


While there is a cisplatin shortage in the United States, the FDA has approved the importation of select chemotherapy drugs from China to help mitigate the scarcity of the agents.

As cisplatin is in such short supply, the FDA has approved the use of imported cisplatin from China to be used in care across the country. Kirollos Hanna, PharmD, BCPS, BCOP, FACCC, spoke with CancerNetwork® about the implications of this decision.

Hanna, director of Minnesota Oncology Pharmacy Services, and assistant professor of Pharmacy at the Mayo Clinic, noted that there are no real concerns with this importation strategy, as the concentration will be the same as what is seen in the United States, and a temporary national drug code number will be created to help with billing and insurance claims.


It’s exciting to see the FDA thinking of unique strategies to bring in drug supply to alleviate some of the things we’re seeing here in the United States. It makes you think, why haven’t we been doing this over time to try to improve supply chain in any type of drug shortages? How long have drug shortages been impacting us here in the United States? This is an exciting opportunity for patients.

The FDA has also partnered with Apotek Pharmaceuticals. They are one of the biotech companies here in the United States that is responsible for the distribution of this inventory. They’re working with our wholesale distributors, like McKesson and Cardinal, to get this [product] out. For patients, I think that this is an exciting opportunity where this has helped alleviate the shortage to some extent, as well as some small supply that has also been released by many of our generic manufacturers here in the United States. I don’t think in terms of manufacturing and quality assurance that there are any major concerns greater than the state of the shortage. Although [the treatments are] coming and not vetted through the normal channels we have here in the United States with our manufacturing, certainly the shortage in terms of patient impact is much greater. I am happy that we're able to bring this in.

The drug is the same concentration; what we have in the United States is a 50 mg vial. There will be a temporary NDC [national drug code] number generated for this product as well to help in terms of billing and processing insurance claims.

We have already seen with this importation of supply that our allocations from our wholesale distributor have increased. They haven’t increased to a comfortable level where we’re just opening prescribing backup. During the most intense parts of the shortage around cisplatin, we were conserving utility in 2 patient populations. It was curative intent for bladder cancer and curative intent for testicular cancer because of the limited opportunity. Now with what we’ve been able to get in, we have further expanded additional indications like head and neck cancers and some cervical cancers where you still have curative intent with cisplatin and limited opportunities outside of that.

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