FDA grants priority review to Roche breast cancer drug

Key facts

• FDA granted priority review to Roche's giredestrant.
• The drug is for ER-positive, HER2-negative breast cancer.
• Priority review designation speeds up the FDA's decision-making process.

The U.S. Food and Drug Administration (FDA) has granted priority review to Roche's drug giredestrant. This designation is specifically for the drug's potential use in treating patients diagnosed with ER-positive, HER2-negative breast cancer. Priority review signifies that the FDA will expedite its evaluation of the drug's application, aiming to make a decision more rapidly than under standard review.