Pfizer is preparing to initiate a multi-center, open-label expanded access program (EAP) for an investigational treatment for post-menopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer in the United States. The program aims to test the novel cyclin-dependent kinases (CDK) 4/6 inhibitor palbociclib in combination with letrozole, which is already used to treat the condition.
The company is seeking to enroll post-menopausal women who are 18 years of age or more and have a proven diagnosis of advanced adenocarcinoma of the breast, including loco regionally recurrent or metastatic disease and ER-positive and/or PR-positive tumor based on local laboratory results, as well as HER2-negative tumor based on local laboratory results.
Patients must be appropriate candidates for letrozole therapy and must not have previously participated in a palbociclib trial or received prior treatment with any CDK inhibitor. During the trial, Palbociclib will be administered orally once a day at 125 mg/day for 21 days followed by 7 days off treatment for each 28-day cycle, while Letrozole will be administered orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information.
“Palbociclib is being evaluated as a potential new treatment for women with HR+, HER2- advanced breast cancer, who represent the largest subgroup of women with this disease,” explained the senior vice president, Clinical Development and Medical Affairs, and chief medical officer of Pfizer Oncology, Dr. Mace Rothenberg.
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“As announced this week, we have completed the submission of a New Drug Application for palbociclib in the U.S. based on the results of our Phase 2, PALOMA-1 study. With recruitment of new patients to our Phase 3 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,” he added.
Palbociclib is an investigational oral agent that works by inhibiting the CDK 4 and 6 to regain cell cycle control and block tumor cell proliferation. It aims to treat one of the consequences of the cancer, the loss of cell cycle control, which leads to the loss of proliferative control by conditioning the CDK, the two main cell cycle regulators and cellular progression triggers.
The U.S. Food and Drug Administration expanded access programs allow companies to investigate their novel treatments with patients who suffer from serious or life-threatening diseases, who normally wouldn’t qualify for participation in a clinical trial otherwise, or who have no other options of treatment.