FDA approves drug combination for early-stage, high-risk breast cancer

The U.S. Food and Drug Administration announced that it has approved a novel drug combination — ribociclib plus an aromatase inhibitor — to treat patients with early-stage breast cancer with a high risk of recurrence.

The approval came after positive results were reported in the NATALEE trial, in which more than 5,000 patients were randomly assigned to receive either ribociclib plus the aromatase inhibitor or the aromatase inhibitor alone.

Compared with the patients who received the aromatase inhibitor alone, those who received the combination therapy had improved disease-free survival. Adverse reactions were also consistent with the known safety profile of ribociclib combined with the aromatase inhibitor.

Read more: FDA

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