Puma Biotechnology reports the U.S. Food and Drug Administration has posted the documents that were used for briefing at the Oncologic Drugs Advisory Committee (ODAC) May 24.
Puma Biotechnology, a biopharmaceutical company, is dedicated to developing cancer treatments. PB272 (neratinib) is an irreversible tyrosine kinase inhibitor that helps to block certain signals associated with the spread of cancer.
The ODAC meeting covered PB272 (neratinib), which is an adjuvant treatment for HER2-positive early stage breast cancer.
The ODAC is made up of a panel of health care experts who assess the risks associated with new cancer treatments. The committee then consults the FDA concerning potential problems associated with the medications. While the FDA is not required to comply with the recommendations of the ODAC, it may find the information provided to be helpful.