On April 2, 2017 Puma Biotechnology, Inc. (Nasdaq: PBYI), 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 (Press release, Puma Biotechnology, APR 2, 2017, View Source [SID1234518371]). Schedule your 30 min Free 1stOncology Demo! 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.
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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."
About the Neratinib Expanded Access Program
The neratinib EAP is a program for U.S. patients with early stage HER2-positive breast cancer (extended adjuvant setting), HER2-positive metastatic breast cancer and HER2-mutated solid tumors. This EAP is being administered on behalf of Puma by Caligor Opco LLC. U.S. healthcare professionals seeking more information about the neratinib EAP can email [email protected] for additional information. Patients who are interested in enrolling in the neratinib EAP should speak with their physician to determine if neratinib is an appropriate option. Neratinib is an investigational agent and, as such, has not been approved by the FDA or any other regulatory agencies in any markets.
About Caligor
Caligor Opco LLC, a portfolio company of Diversis Capital, LLC, is a global company that manages the regulatory, logistics and supply chain needs for global access programs as well as the sourcing, storing and distribution of comparator drugs for clinical trials. Caligor’s global access programs help to meet the medical needs of patients worldwide by providing access to medicines in situations where the drug has not yet been approved, or is otherwise commercially unavailable. In addition, through its proprietary TrialAssist program, Caligor optimizes its services by providing for labeling, QP certification, storage, distribution and destruction of clinical trial and unlicensed medicines managed in the access programs. The company serves pharmaceutical and biotechnology companies from facilities in Secaucus, New Jersey and Dartford, UK, as well as strategically situated depot locations worldwide. More information is available at View Source