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FDA Advisory Committee Recommends Approval of Puma Biotech’s Breast Cancer Drug

LOS ANGELES–(BUSINESS WIRE)–Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, today announced that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 12 – 4 to recommend approval of 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 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.

“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.

“We appreciate the committee’s comments and the support of the many clinicians, patients and advocates who participated in today’s meeting,” Mr. Auerbach added. “We look forward to further discussion with the FDA.”

About Puma Biotechnology

Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. The Company in-licenses the global development and commercialization rights to three drug candidates—PB272 (neratinib (oral)), PB272 (neratinib (intravenous)) and PB357. Neratinib is a potent irreversible tyrosine kinase inhibitor that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2 and HER4. Currently, the Company is primarily focused on the development of the oral version of neratinib, and its most advanced drug candidates are directed at the treatment of HER2-positive breast cancer. The Company believes that neratinib has clinical application in the treatment of several other cancers as well, including non-small cell lung cancer and other tumor types that over-express or have a mutation in HER2. Further information about Puma Biotechnology can be found at

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