FDA approves application for breast cancer drug from Pfizer

Pfizer Inc.'s supplemental New Drug Application (sNDA) for Ibrance, its first-in-class cyclin dependent kinase 4/6 (CDK 4/6) inhibitor, has been approved by the U.S. Food and Drug Administration.
With the new approval, Ibrance can be used in combination with an aromatase inhibitor for treating postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer.
The approval comes after a Phase 3 study that evaluated Ibrance first-line therapy in combination with letrozole for postmenopausal women with estrogen receptor-positive (ER+), HER2- metastatic breast cancer.
“In the two years since its initial approval, IBRANCE has been prescribed to more than 50,000 patients by more than 9,800 physicians in the U.S.,” Liz Barrett, global president and general manager of Pfizer Oncology, said in a statement. “This important update to the IBRANCE label underscores the strength of the data we continue to generate for IBRANCE. We are proud of the impact this innovative medicine continues to have on patients’ lives.”