FDA’s Oncologic Drugs Advisory Committee (ODAC) has recommended approval of Puma Biotechnology’s PB272 (neratinib) for the extended adjuvant treatment of HER2-positive early stage breast cancer based on finding that the risk-benefit profile of neratinib is favorable.
The ODAC voted 12 to 4 in favor of the drug saying that the vote was based on a review of the clinical development program that included 11 trials in breast cancer and represented approximately 2,000 patient years’ experience.
The focus of the ODAC meeting was the Phase III ExteNET study, which provided one year of continuous therapy with neratinib after patients completed one year of therapy with a trastuzumab-based regimen. The study demonstrated a statistically significant 33% relative reduction of risk of invasive disease recurrence within two years after treatment, Puma said in its press release.
“Despite advances in adjuvant therapy for HER2-positive breast cancer, disease recurrence remains a risk. Since there are no effective therapies for patients whose disease recurs, there is an important need for additional options to further reduce the risk of recurrence,” said Alan H. Auerbach, Chief Executive Officer and President of Puma Biotechnology.
ODAC is an independent panel of experts that evaluates data concerning the efficacy and safety of marketed and investigational cancer treatments and makes appropriate recommendations to the FDA. Its vote is not binding, but is considered by the FDA in its decision making process.