The agency will allow imports of the chemotherapy drug cisplatin, which is used to treat a wide variety of cancers.
(NBC-Berkeley Lovelace Jr) — The Food and Drug Administration is working with a Chinese drugmaker to import the chemotherapy drug cisplatin, a strategy aimed at ramping up supply amid an ongoing shortage of the drug in the United States.
The FDA is also exploring importing carboplatin, another chemotherapy drug in shortage, according to James McKinney, an agency spokesperson. However, McKinney told NBC News the agency could not yet share specifics on the potential supplier for that drug.
The decision by the FDA to work with a foreign drugmaker comes as the U.S. faces a widespread shortage of more than a dozen cancer drugs.
Cisplatin has been in shortage in the U.S. since February, while carboplatin has been in shortage since late April.
Cisplatin, from drugmaker Qilu Pharmaceutical, is marketed and manufactured in China, but is not approved by the FDA in the U.S. Qilu will work with the Canada-based drugmaker Apotex to import and distribute the medication, according to a letter from the company dated May 24. The drug will come in 50-milligram vials that are labeled in Chinese.
Health care providers should be able to begin ordering the drug on Tuesday, McKinney said.
Working with a Chinese drugmaker to boost the supply of cisplatin is a good plan, said Eric Tichy, board chair of the End Drug Shortages Alliance, a group dedicated to solving drug supply chain problems.
Platinum-based drugs, which includes cisplatin and carboplatin, are prescribed to an estimated 10% to 20% of all cancer patients, according to the National Cancer Institute. They are used for a range of cancers, including testicular, lung, bladder, cervical and ovarian.
The shortage means some patients will go without the medication.
“Anything the FDA can do to bring more supply of cisplatin into the U.S. will be helpful,” Tichy said. “The FDA should consider importation when that option is available from a reliable source when there is a severe shortage.”
It is not yet known whether the FDA will use this strategy for other cancer medications, outside of cisplatin and carboplatin.
In a tweet Friday, FDA Commissioner Dr. Robert Califf said the collaboration with Qilu Pharmaceutical is temporary but will provide patients with a potentially life-extending drug.
“The public should rest assured that we will continue all efforts within our authority to help the industry that manufactures and distributes these drugs meet all patient needs for the oncology drugs impacted by shortages,” he said.