Amgen is going before the FDA's Oncologic Drugs Advisory Committee (ODAC) in order to discuss its BLA for Nplate (romiplostim). The drug is a treatment for thrombocytopenia, a disorder that causes the body to attack its own blood clotting cells. The FDA is concerned about adverse reactions noted in clinical trials. These include significantly higher platelet levels, dangerous blood clots, bone marrow growth and malignant tumors in those taking the drug. The experts will advise the FDA whether Nplate's benefits outweigh the risks, and whether it should be given a limited approval.
- check out this release
- and read the AP article for more
ALSO: Here's a peek into the FDA playbook for tomorrow's advisory panel on Amgen and Johnson & Johnson's anemia drugs. According to documents posted on the agency's website, those expert advisors will be asked to consider several limitations on the meds, which have been linked to increased tumor growth and reduced survival among some cancer patients. And the options include yanking FDA approval for that use. Report