Women with HER2-positive breast cancer or HER-mutated cancers who cannot participate in any PB272 (neratinib) clinical trial may now receive the investigational drug under the expanded access program (EAP) initiated by Los Angeles-based Puma Biotechnology.
The U.S. Food and Drug Administration (FDA) lets drugmakers provide pharmaceuticals to seriously ill patients who do not quality for controlled trials of a drug because of health problems, age or other factors. The EAP will now make PB272 available to women with early stage HER2+ breast cancer, HER2+ metastatic breast cancer or HER2-mutated solid tumors.
Caligor Opco, a New Jersey company that administers the Managed Access Program for neratinib, will also manage the EAP on behalf of Puma 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,” Puma President and CEO Alan H. Auerbach said in a news release. “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.”
PB272 is an irreversible tyrosine kinase inhibitor that Puma is developing as an oral treatment for patients with HER2+ breast cancer. A Phase 2 clinical trial whose results were published in 2010 showed that PB272 by itself benefits HER+ metastatic breast cancer patients.
In addition, recent data from a Phase 1/2 trial has shown that it has promising response rates when combined with Kadcyla (ado-trastuzumab emtansine) in patients with HER2+ metastatic breast cancer.
Neratinib is currently being tested in several clinical trials for both early-stage HER2+ breast cancer and HER2+ metastatic breast cancer. Three such studies are enrolling participants; a Phase 3 trial of HER2+ metastatic breast cancer patients who received two prior treatments for metastatic disease (NCT01808573), a Phase 2 trial for early-stage HER2+ breast cancer (NCT02400476), and a Phase 2 trial for solid cancer patients with HER2, HER3, or EGFR mutations (NCT01953926).
Neratinib has not been approved by the FDA or any other regulatory agency. Patients who wish to enroll in the neratinib EAP should speak with their doctors to determine if this experimental treatment is appropriate for their disease.