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# Orphan Drug Designation for Puma’s Alisertib
- URL: https://www.fdaweb.com/orphan-drug-designation-for-pumas-alisertib/
- Published: 2023-09-21T12:00:00.000Z
- Updated: 2026-09-14T18:57:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155390

FDA has approved an orphan drug designation for Puma Biotechnology’s alisertib, described as a selective, small-molecule, orally administered inhibitor of aurora kinase A, to treat patients with small cell lung cancer. A company [statement](https://investor.pumabiotechnology.com/news-releases/news-details/2023/Puma-Biotechnology-Receives-FDA-Orphan-Drug-Designation-for-Alisertib-for-the-Treatment-of-Small-Cell-Lung-Cancer/default.aspx?ref=fdaweb.com) says FDA cleared Puma’s IND for the clinical development of aliserib monotherapy to treat patients with extensive stage small cell lung cancer in 8/2023 and anticipates starting a Phase 2 trial later this year.