“This 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 while neratinib is still an investigational agent,” Karen Frascello, vice president of business development at Caligor Opco.
Caligor Opco manages regulatory, logistics, and supply chain needs for global access programs. It also sources, stores, and distributes comparator drugs for clinical trials.
Frascello explained the company helps advance the program by “efficiently meeting the needs of all stakeholders,” which enables Puma to focus on neratinib clinical development and ongoing regulatory activities.
Caligor will also help Puma manage health care professional (HCP) requests for neratinib.
“We will also communicate with HCPs to help manage neratinib treatment and facilitate access to re-supply of neratinib for patients,” added Frascello.
“Our clinical operations team will respond to general inquiries from US HCPs; explain the EAP requirements to HCPs; and assist in answering regulatory questions as well as those related to Institutional Review Board (IRB) approvals,” she explained.
Additionally, the company will work the Puma’s drug supply personnel to coordinate neratinib shipments to physician practices or hospitals.
Currently, the US EAP is open and accepting unsolicited patient access requests to neratinib from HCPs.
Frascello explained the program will close “if and when” neratinib gains FDA approval. “The specific parameters of the program are set forth by Puma Biotechnology,” she added.