The Food and Drug Administration (FDA) authorized the importation of the chemotherapy drug cisplatin from China in an effort to boost supply amidst the ongoing shortage.
Qilu Pharmaceutical, a Chinese company that makes cisplatin injections, received temporary FDA approval in late May, according to a document notifying about the authorization. The 50-milligram cisplatin vials will be distributed in the United States market by Toronto-based company Apotex.
Cisplatin, a platinum-based drug, is best known for curing testicular cancer. When combined with other chemotherapy drugs, it has a cure rate of more than 90%. Cisplatin can also be used to treat lung, bladder, cervical, and ovarian cancers.
Active drug shortages in the U.S. reached a peak of nearly 300 products at the end of 2022, according to a report by the Senate Committee on Homeland Security and Governmental Affairs.
Richard Pazdur, director of the FDA Oncology Center of Excellence, says that the current cisplatin shortage followed an inspection and subsequent identification of quality issues at a single company’s manufacturing facility. This led to an increased demand for carboplatin, another chemotherapy drug, and the manufacturing challenges in meeting increased demand.
Currently, 14 oncology medications, including cisplatin and carboplatin, are listed as "in shortage" by U.S. regulators. Major oncology organizations and hospitals report rationing treatments, leaving patients with delayed chemotherapy or possibly less effective drugs. In some cases, doctors are forced to make the hard decision of prioritizing only patients who stand a chance of being cured.
- FDA. Temporary Importation of CISplatin Injection with non-U.S. Labeling to Address Drug Shortage.
- National Cancer Institute. Temporary Importation of CISplatin Injection with non-U.S. Labeling to Address Drug Shortage.
- Senate Committee on Homeland Security and Governmental. Short Supply. The Health and National Security Risks of Drug Shortages
- Cancer Letter. Richard Pazdur discusses root causes of cisplatin and carboplatin shortage and what can be done to alleviate it.