Puma Biotechnology receives FDA Committee Approval for Neratinib

Committee voted 12 – 4 to recommend approval of Neratinib, for the extended adjuvant treatment of HER2-positive early stage breast cancer

The study demonstrated a statistically significant 33% relative reduction of risk of invasive disease recurrence within two years after treatment

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#Puma Biotechnology $PBYI announced that the U.S. FDA Oncologic Drugs Advisory Committee voted 12 – 4 to recommend approval of PB272, or 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 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 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.

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. “We appreciate the committee’s comments and the support of the many clinicians, patients and advocates who participated in today’s meeting,” Alan H. Auerbach, CEO and President of Puma Biotechnology, said. “We look forward to further discussion with the FDA.”

The stock was last up over 25.2% to $72.40.

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