FDA greenlights imports of China cancer drug with up to 90% cure rate

The Food and Drug Administration (FDA) has announced that a drug that forms the ‘backbone’ of chemotherapy will be imported from China to the US.

Cisplatin – used by up to one in five cancer patients – has been in short supply since February, caused by the closure of a major supplier.

This drug, which has a 90 percent cure rate for testicular cancer, treats many types of illnesses affecting the bladder, cervix, ovaries, lungs, breasts, and head and neck.

To support expiring supplies, the FDA approved a company outside of Beijing to manufacture and deliver doses.

The agency also plans to approve a new supplier for another chemotherapy drug, carboplatin, which has been in short supply since late April.

Nearly two dozen chemotherapy drugs are in short supply across the country amid a national drug shortage, forcing many doctors to turn to alternatives that may be less effective.

The FDA announced last week that it had approved Qilu Pharmaceuticals to begin supplying cisplatin to the US.

The doses come in 50-milligram vials labeled in Chinese and will be distributed by Canadian company Apotex, with deliveries expected to begin within weeks.

Cisplatin is one of the best chemotherapy drugs available, says Johns Hopkins oncologist Dr. Amanda Fader CNN that it is ‘the backbone of chemotherapy’.

Announcing the deal, FDA Commissioner Dr. Robert Califf: “We have taken steps to temporarily import certain foreign-approved versions of cisplatin products from FDA-registered facilities.

‘[We’ve] uses regulatory discretion for continuous delivery of other cisplatin and carboplatin products to help meet patient needs.”

He added: “In these situations, we assess product quality very carefully and require companies to take certain measures to ensure that the products are safe for patients.

“The public must be assured that we will continue all efforts within our authority to assist the industry that produces and distributes these drugs to meet all patient needs.

“

Shortages of cisplatin in the US arose when India-based supplier Intas Pharmaceuticals, one of the largest manufacturers, was shut down after a failed inspection.

The inspection was cited as a “textbook example of what not to do when investigators come knocking” after the FDA shut down the plant, saying it found shredded documents and bins of acid in the facility.

This quickly led to a shortage, with most manufacturers of the drugs already running at near capacity unable to make up for the shortage.

The US plans to import doses of the chemotherapy drug cisplatin from China to help alleviate the shortages. It is administered to patients intravenously

It has led regulators in the US to turn to China, the country’s fourth-largest drug supplier, for help.

There are concerns in some political circles that China could weaponize these drugs against America to force concessions.

Rosemary Gibson, a senior health care adviser at a New York-based think tank, earlier said: ‘Medicines can be used as a weapon against the United States.

‘Deliveries can be withheld. Medicines can be made with deadly contaminants or sold without real medicines in them, making them ineffective.’

Dr. Fader said the shortages had forced doctors to replace cisplatin with other drugs.

“In many cases, these drug replacements will be just as effective in terms of response to treatment,” she said.

“However, many of these drugs may have worse side effects profiles or different dosing schedules that take two or three times longer to deliver.”

The FDA also resorted to drug importation last year because of a shortage of the chemotherapy drug Doxil, which can be used to treat ovarian and breast cancer.

Cisplatin works by interfering with the DNA of cancer cells to cause their death, clearing the disease from the body.

It is usually given intravenously by healthcare providers and patients can be treated for weeks at a time.