FDA to have Genzyme plant inspected, reviewed
CAMBRIDGE, Mass. Genzyme Corp. will have to submit to inspections of one of its plants by the Food and Drug Administration and pay fees to the agency under a consent decree, the biotechnology company said Wednesday.
The FDA will likely hire a third party to inspect and review Genzyme’s plant in the Boston neighborhood of Allston for an extended period of time to ensure its compliance with accepted manufacturing standards. Genzyme will also have to pay the FDA for the inspections, and may have to pay other fees as well.
The action comes as a result of an incident in June 2009, when the company detected a virus that inhibits cell growth in one of the containers it uses to manufacture drugs; the virus, vesivirus 2117, is not known to cause human infection. The company said the virus was the cause of declines in productivity at two of its plants, including Allston, in 2008, and was likely introduced via a nutrient used in the manufacturing process.
In November 2009, the company found particulate matter in supplies of drugs from the Allston plant, particularly the Gaucher disease drug Cerezyme (imiglucerase), the Fabry disease drug Fabrazyme (agalsidase beta), the Pompe disease drug Myozyme (alglucosidase alfa), the mucopolysaccharidosis treatment Aldurazyme (laronidase) and the thyroid disease drug Thyrogen (thyrotropin alfa).
The drug maker said it expected shipments of the Cerezyme, Fabrazyme and Myozyme, which are manufactured at the Allston plant, to continue uninterrupted.
FDA committee won’t recommend approval for non-Hodgkin’s lymphoma treatment
GAITHERSBURG, Md. A Food and Drug Administration advisory committee declined to recommend approval for a cancer drug made by Cell Therapeutics, the company announced Monday.
Cell Therapeutics said the FDA’s Oncologic Drugs Advisory Committee voted unanimously that data from clinical trials of pixantrone, a treatment for non-Hodgkin’s lymphoma, did not support its approval. Pixantrone would have been the first drug to treat relapsed or refractory NHL in patients who had received two or more prior therapies.
The FDA is not bound by the recommendations of advisory committees, and the agency is expected to decide whether or not to approve pixantrone on April 23. It does, however, take the recommendations into account when deciding whether or not to approve a drug, and the committee’s vote will likely diminish pixantrone’s chances for winning approval.
Merck KGaA suspends cancer vaccine trial
DARMSTADT, Germany A mid-stage clinical trial program to investigate a Merck KGaA cancer vaccine has been put on hold due to patients’ experiencing adverse side effects, the German drug maker announced Tuesday.
Merck KGaA, which is separate from the U.S.-based Merck & Co. and operates in the United States under the name EMD, said it temporarily suspended recruitment and treatment of patients in the phase 2 trial for Stimuvax (BLP25 liposome vaccine) after a patient with the bone marrow cancer multiple myeloma developed encephalitis. Merck said it made its decision under in alignment with a Food and Drug Administration hold placed on its investigational new drug application for Stimuvax.
The patient who developed encephalitis, a potentially fatal inflammation of the brain, was in an experimental arm of the clinical program and taking Stimuvax in combination with low doses of the cancer drug cyclophosphamide, which was not used in the other Stimuvax studies.
Another program, a phase 3 trial involving patients with non-small cell lung cancer and breast cancer, is affected as well, though Merck did not say exactly how.