WHO warns of falsified AstraZeneca cancer drug

Falsified copies of AstraZeneca's cancer immunotherapy Imfinzi have been detected in Armenia, Lebanon and Türkiye, according to the World Health Organization (WHO).

The Imfinzi (durvalumab) 500mg/10ml vials – used as a monotherapy for the treatment of non-small cell lung cancer (NSCLC) – were found in the unregulated supply chain, said the agency in a medical product alert. The vials have been tested by AZ, which concluded they were counterfeit and contained no active pharmaceutical ingredient (API).

"These falsified products should be considered unsafe, and their use may be life-threatening in some circumstances," said the WHO. "The use of these falsified Imfinzi products may lead to ineffective or delayed treatment.

The counterfeits were all in falsified packaging bearing the lot number BAVX – which if genuine should have a manufacturing date of 10-2021 and an expiry date of 09-2024. Those found in Lebanon and Türkiye had those dates, while the version found in Armenia used a manufacturing date of 10-2023 and an expiry of 09-2026.

"A combination of any other dates or lot number should be considered suspicious," according to the WHO alert, which also notes that on the counterfeits the 2D datamatrix code is displayed in the middle instead of the upper-right of the box, and the face of the pack where the datamatrix, lot number, manufacturing and expiry dates are displayed should be in black and white, not totally black.

Furthermore, the rectangle, displaying the strength of the medicine, should be in paler green rather than dark green, and the metal crimp of the closure around the neck of the vial should not be creased (see images below).