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FDA grants priority review to palbociclib for advanced breast cancer
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The FDA granted priority review status to palbociclib for use with letrozole in first-line treatment for postmenopausal women with ER-positive, HER-2–negative advanced breast cancer who have not received previous systemic treatment, according to the drug’s manufacturer.
Palbociclib (PD-0332991, Pfizer), an inhibitor of cyclin-dependent kinases (CDK) 4 and 6, prevents DNA synthesis by blocking cell cycle progression.
“If approved as a first-line therapy in combination with letrozole, palbociclib will be an important new option for the thousands of women in the United States who are living with metastatic breast cancer,” Garry Nicholson, president of Pfizer Oncology, said in a press release. “We look forward to continuing to work closely with the FDA through the review process.”
The FDA based its decision in part on the final results of the phase 2 PALOMA-1 trial, which included patients with ER-positive, HER-2–negative advanced breast cancer. Researchers assigned patients to palbociclib (125 mg once daily for 3 out of 4 weeks in repeated cycles) plus letrozole (2.5 mg once daily on a continuous regimen), or letrozole alone.
The interim analysis showed median PFS — the study’s primary endpoint — was 26.1 months among patients assigned to the combination vs. 7.5 months among patients assigned to letrozole alone (HR=0.37; 95% CI, 0.21-0.63).
Adverse events in the palbociclib arm were consistent with the known adverse event profile for this combination.
The FDA grants priority review designation to drugs that may offer major advances in treatment or provide a treatment where no adequate therapy exists. The FDA is expected to announce its decision about palbociclib by April 13, 2015.
In addition, Pfizer announced the initiation of a multicenter, open-label expanded access program in the United States that would make palbociclib available to post-menopausal women with HR-positive, HER-2–advanced breast cancer who are eligible for letrozole therapy and for whom enrolling in other palbociclib clinical trials is not an option.