Puma Biotechnology Launches Expanded Access Program for PB272 (Neratinib)

Puma Biotechnology, Inc., a biopharmaceutical company, has initiated an expanded access program (EAP) in the United States to provide its investigational therapy, PB272 (neratinib), to patients with HER2-positive breast cancer or HER2-mutated cancers. The program will provide access to neratinib for the treatment of early stage HER2-positive breast cancer (extended adjuvant setting), HER2-positive metastatic breast cancer and HER2-mutated solid tumors. Patients must not be able to participate in any ongoing neratinib clinical trial to qualify for Puma’s expanded access program. Puma announced a Managed Access Program for neratinib outside the United States in the fourth quarter of 2016.

The U.S. Food and Drug Administration (FDA) permits expanded access to investigational drugs for treatment use for patients with serious or immediately life-threatening diseases or conditions who do not otherwise qualify for participation in a clinical trial and lack satisfactory therapeutic alternatives.

Caligor Opco LLC, which administers the Managed Access Program for neratinib, also will manage the U.S. expanded access program by providing regulatory and logistical support.

“This expanded access program reflects our commitment to make neratinib available to eligible patients who lack therapeutic treatment options,” said Alan H. Auerbach, Chief Executive Officer and President of Puma. “As a specialist firm that focuses on early access to medicines, Caligor will facilitate access to neratinib for patients who may benefit from this therapy.”