On April 12, 2017 Caligor Opco LLC, which specializes in early access to medicines and drug life-cycle management, reported that it will provide regulatory and logistical management for Puma Biotechnology’s (Nasdaq: PBYI) expanded access program (EAP) for its investigational breast cancer therapy, PB272 (neratinib), in the United States (Press release, Caligor Opco, APR 12, 2017, View Source [SID1234518531]). Schedule your 30 min Free 1stOncology Demo! 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.
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The EAP 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 the EAP. Caligor also is providing regulatory, logistical, and supply chain support for Puma’s Managed Access Program for neratinib outside the United States.
"We are gratified by the trust and confidence Puma has placed in us," said Tammy Bishop, Caligor’s Chief Commercial Officer. "Within the past year, the FDA has introduced a streamlined application process and new guidance designed to improve its expanded access programs, and those initiatives have been extremely positive. We look forward to working with regulators and physicians to 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. 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.