Pfizer has announced a label expansion for its breast cancer drug, Ibrance, after the FDA extended its approval. The FDA approved the use of Ibrance in combination with an aromatase inhibitor for newly diagnosed HR-positive, HER2-negative metastatic breast cancer patients regardless of menopausal status, whereas before it was only approved for use in postmenopausal women. Pfizer made the announcement during its fourth-quarter earnings announcement. The label expansion is unusual as there was no new efficacy data in the patient population and the label only includes results from the phase 3 PALOMA-2 and PALOMA-3 trials.
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