Inavolisib: First Approval

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Roche. FDA grants Breakthrough Therapy Designation to Roche's inavolisib for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation [media release]. 21 May 2024. http://www.roche.com.

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Foundation Medicine. U.S. Food and Drug Administration approves FoundationOne® Liquid CDx as a companion diagnostic for Itovebi™ (inavolisib) to identify patients with hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation [media release]. 11 Oct 2024. http://www.foundationmedicine.com.

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