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Puma Provides $2M Grant to Explore New Neratinib Indications

NEW YORK – The National Comprehensive Cancer Network's Oncology Research Program said on Thursday that Puma Biotechnology is providing a $2 million grant to advance research exploring that activity of its HER2-directed drug neratinib (Nerlynx) in new molecularly defined indications.

The NCCN's research program will put out a request for proposals (RFP) early next year for preclinical, translational, and clinical studies to investigate neratinib in early-stage and metastatic breast cancer, including cancers that have spread to the brain; other HER2-amplified tumors; EGFR-mutated glioblastoma multiforme; and pediatric tumors, included neurofibromatosis Type 2 and progressive Vestibular Schwannoma.

Neratinib is a dual EGFR and HER2 inhibitor that is already approved in the US as an extended adjuvant treatment after trastuzumab therapy for early-stage, HER2-postive breast cancer patients, and in combination with capecitabine for advanced or metastatic HER2-positive breast cancer patients who have received at least two other anti-HER2 based regimens.

A group of experts from NCCN member institutions will form a RFP development team that will determine the specific research areas related to neratinib.

"We are proud to support NCCN's research projects to better understand the full potential of neratinib across a variety of indications," Puma President and CEO Alan Auerbach said in a statement. "Our goal is to use these insights to expand the potential indications, as well as to identify patients who may benefit from neratinib."