Counterfeit vials were sold and distributed to more than a dozen offices and medical treatment facilities in the U.S. This event, which seems to have affected a small number of patients and practices, should sound a big alarm.
Today’s breaking breast cancer news is on Avastin. The FDA has just announced, formally, that it will rescind approval for the drug’s use in people with metastatic breast cancer. Commissioner Dr. Margaret Hamburg writes this her statement: I know I speak on behalf of the many physicians that have been involved with this issue here […]
Late Friday afternoon, the FDA announced its approval, upon accelerated review, of a new drug, Adcetris (brentuximab) for patients with Hodgkin’s lymphoma that has relapsed after bone marrow transplant and for some patients with T-cell anaplastic large cell lymphoma (ALCL). This interests me for a lot of reasons, among them that I used to work in the field of lymphoma immunology […]
This afternoon Ed Silverman of Pharmalot reports that Roche has proposed a compromise to the FDA over Avastin’s use in women with metastatic breast cancer. The drug would be approved for use only in combination with paclitaxel (Taxol), for which the data are strongest, and with special warnings. He writes: The deal includes revised labeling […]
My cousin testified before the FDA oncology advisory board on Tuesday about her experience taking Avastin. This is a tragedy, to deny the only drug that is keeping a 51 year old woman alive. You have to wonder, are the advisory panel members so rational in all their behavior and choices? Are they always so […]
This week the FDA approved a new assay for Her2 expression in breast cancer biopsies. The technology, Inform Dual ISH, is manufactured by Ventana Medical Systems, a Roche subsidiary. Inform Dual ISH works like this: technicians, typically working under the supervision of a pathologist, expose a tiny bit of a breast biopsy specimen, fixed on […]
The June issue of Wired carries a feature on the Booming Market for Human Breast Milk. You can read about the under-the-counter and over-the-Internet sale of “liquid gold” with a typical asking price in the range of $1 to $2.50 an ounce. Here’s a taste, from the article: …“rich, creamy breast milk!” “fresh and fatty!”… […]