EMA Warns of Falsified Herceptin Vials
EMA notifies EU healthcare professionals of the falsified cancer drug Herceptin.
The European Medicines Agency (EMA) has been informed that vials of the cancer medicine Herceptin, thought to have been stolen in Italy, including from hospitals, have been tampered with and re-introduced under false credentials. Italian law enforcement authorities are currently investigating the theft and are looking at whether other medicines may also be affected.
Currently, no affected product has been identified at the hospital level and there are no reports of any patients being harmed.
Signs that may indicate a vial is not genuine include the following: batch numbers and expiration dates on vials that do not match those on the outer package; the presence of liquid in some vials of Herceptin powder for solution (Herceptin is a white to yellow powder); tampered rubber stoppers, crimping caps or lids; and vials falsely labeled as Italian Herceptin 150 mg.
The numbers of the Herceptin batches known to be affected are H4311B07, H4329B01, H4284B04, H4319B02, H4324B03, H4196B01, H4271B01, H4301B09, and H4303B01. The EMA is coordinating the response by the appropriate health authorities in the Member States.
Source: European Medicines Agency
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
MHRA Approves GSK Therapy Combinations for Multiple Myeloma
April 21st 2025Belantamab mafodotin is approved in combination with bortezomib plus dexamethasone in patients who have had at least one prior therapy, and in combination with pomalidomide plus dexamethasone for those who have had a prior therapy including lenalidomide.
