According to reports, 10 additional lots of cisplatin, manufactured by Qilu Pharmaceuticals in China, have been cleared by the U.S. Food and Drug Administration (FDA) for importation and shipment to the United States. This comes after the agency previously approved the importation of four lots in May. The distribution of these drugs will be handled by Apotex, a Canadian company, and the shipments are expected to arrive this week, according to a spokesperson from Apotex.
Apotex expressed their satisfaction in assisting with addressing the shortage of cisplatin and emphasized their role in alleviating the supply chain challenges. Cisplatin, along with carboplatin, is widely used in various cancer treatments as a standard of care. The recent import clearance was first reported by Bloomberg.
The shortage of cisplatin was triggered by quality issues identified at a manufacturing facility, which had a ripple effect throughout the supply chain, as explained by Richard Pazdur, M.D., the Chief of the FDA’s Oncology Center of Excellence, in an interview with The Cancer Letter in May. The shortage has been further exacerbated by a lack of investment in building production capacity within the industry. Consequently, patients and oncologists across the United States have been affected by the limited availability of these crucial chemotherapy drugs.
A survey conducted by the National Comprehensive Cancer Network in May revealed that 93% of the surveyed cancer treatment centers were experiencing a shortage of carboplatin, while 70% reported a shortage of cisplatin. Hospitals have been compelled to make difficult decisions and prioritize which patients can receive these treatments, as reported by The New York Times.
While the FDA has taken steps to address the shortage, such as allowing Intas Pharmaceuticals from India to continue shipping chemotherapies and other cancer medications despite previous manufacturing deficiencies, Pazdur emphasizes that the agency alone cannot resolve the problem. The FDA carefully evaluates product quality when accepting temporary importations, as highlighted by FDA Commissioner Robert Califf, M.D., in a tweet in June when announcing the initial batch of imports. Califf assured the public that the FDA will continue its efforts, within its authority, to assist the industry in meeting the patient needs for oncology drugs affected by shortages.