FDA clears more chemotherapy imports from China's Qilu amid shortage of key cancer meds

As a shortage of key chemotherapy drugs continues to upend cancer treatment across the country, the FDA has resorted to securing some of the meds from China.

After approving the importation of four lots back in May, the agency has now cleared 10 more lots of cisplatin for shipment to the U.S. from Chinese company Qilu Pharmaceuticals. 

Canada’s Apotex will distribute the drugs, which are expected to arrive this week, a company spokesperson told Fierce Pharma.

Apotex is “very pleased” to aid in addressing the shortage, the spokesperson added.

Cisplatin, along with fellow platinum-based chemotherapy carboplatin, are commonly used as a standard of care across many types of cancer. The newest import was first reported by Bloomberg.

After the FDA flagged quality issues at a facility that produced the drug, a “ripple effect” ensued across the supply chain, the FDA’s Oncology Center of Excellence chief Richard Pazdur, M.D., told The Cancer Letter in May.

The shortage has been exacerbated by an industry failure to invest in building production capacity, Pazdur added. Now, patients and oncologists across the country are feeling the impacts.

In May, a National Comprehensive Cancer Network survey found that 93% of 27 cancer treatment centers surveyed are low on carboplatin, whereas 70% reported a cisplatin shortage.

Meanwhile, hospitals have been forced to make tough choices by prioritizing which patients can receive the treatments, The New York Times has reported.

While the FDA is doing what it can, including allowing India’s Intas Pharmaceuticals to continue shipping the chemotherapies and other cancer meds despite previously being dinged for manufacturing deficiencies, Pazdur says the agency can’t fix the problem on its own. 

The agency “very carefully” assesses product quality when accepting temporary importations, FDA Commissioner Robert Califf, M.D., noted in a June tweet announcing the first batch of imports.

“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,” Califf added at the time.