Details

Autor(en) / Beteiligte

• Goozner, Merrill

Titel

FDA Increases Focus on Postmarketing Studies

Ist Teil von

• JNCI : Journal of the National Cancer Institute, 2010-09, Vol.102 (17), p.1302-1304

Ort / Verlag

United States: Oxford University Press

Erscheinungsjahr

2010

Quelle

Oxford Journals 2020 Medicine

Beschreibungen/Notizen

• Under pressure from Capitol Hill, the US Food and Drug Administration (FDA is pushing drug companies to channel more resources into completing confirmatory trials for cancer drugs approved under the accelerated approval program. In mid-July, the FDA's Oncology Drugs Advisory Committee (ODAC) voted 12-1 against using bevacizumab (Avastin) with chemotherapy regimens for metastatic breast cancer that is HER2 and hormone receptor negative. The FDA, however, in a rare rejection of a committee recommendation, agreed to add the metastatic breast cancer indication to the bevacizumab label. Agency officials based their decision on interim data from one of the confirmatory trials, which was submitted a few week after the ODAC meeting and appeared to confirm the first trial's results for PFS, a surrogate marker that FDA officials agree can have value independent of long-term survival for cancer patients.