This [expanded access] program will provide a mechanism by which eligible women who may benefit from treatment with palbociclib can gain access to this investigational therapy at this time.
—Mace Rothenberg, MD
Pfizer Inc announced that the company has initiated a multicenter, open-label expanded access program in the United States for the investigational oral CDK 4/6 inhibitor, palbociclib. Through the program, palbociclib is being made available for use in combination with letrozole for postmenopausal women with hormone receptor–positive, HER2-negative advanced breast cancer for whom letrozole is considered appropriate therapy.
“Palbociclib is being evaluated as a potential new treatment for women with hormone receptor–positive, HER2-negative advanced breast cancer,” said Mace Rothenberg, MD, Senior Vice President, Clinical Development and Medical Affairs, and Chief Medical Officer, Pfizer Oncology. “We have completed the submission of a New Drug Application for palbociclib in the United States based on the results of our phase II PALOMA-1 study. With recruitment of new patients to our phase III PALOMA-2 and PALOMA-3 trials now complete, Pfizer is initiating the palbociclib expanded access program. This program will provide a mechanism by which eligible women who may benefit from treatment with palbociclib can gain access to this investigational therapy at this time.”
Expanded Access Program
The palbociclib expanded access program is a U.S.-only, single-arm, open label study for postmenopausal women with hormone receptor–positive, HER2-negative advanced breast cancer. Women enrolled in the study will receive palbociclib for use in combination with letrozole, and therefore must be deemed appropriate for letrozole therapy.
Under its expanded access programs, the U.S. Food and Drug Administration works with companies to allow access to investigational therapies to patients with serious or life-threatening illnesses who do not otherwise qualify for participation in a clinical trial and for whom there are no satisfactory alternate therapies.
Health-care professionals and patients can learn more about the palbociclib expanded access program by visiting www.clinicaltrials.gov (trial number: NCT02142868).
U.S.-based health-care professionals seeking more information may also call 1-800-420-6755 or e-mail Palbociclib-EAP@parexel.com for further details. ■