Roche agrees EMEA plan on Herceptin vial inspection

Roche has agreed to a plan to visually re-inspect vials of its breast cancer treatment Herceptin (trastuzumab), after the European Medicines Agency (EMEA) received reports of cracks in vials of the compound.

The agency’s Committee for Medicinal Products for Human Use has agreed the plan to identify any vials that are defective and remove them from the supply chain, while preventing interruption of patient treatment by attempting to ensure continued supply of the drug.

“Roche has received about 20 complaints of cracked vials from hospitals in France, Germany, Ireland and the United Kingdom. In most cases the vials had broken when the flip-top cap was removed,” the EMA reports.

Vials packaged from March 2006 may be affected by the cracks and while the agency reports that the defect does not affect the sterility of the compound, re-inspection and replacement has been recommended as a precaution.

The agency noted that company inspections revealed that one in 1,000 vials of 13,000 were cracked. It added that hospitals receiving batches before November 2006 had been given instructions for the inspection and return of affected vials.

Last month, Roche presented data to the European Society for Medical Oncology showing the enhanced longevity of the efficacy of a Herceptin and anastrozole combination in managing cancer in patients with hormone receptor and HER2-positive advanced breast cancer, when compared with treatment with anastrozole alone.