06/17/2026

Recent Oncology Related FDA Approvals and Expanded Indications

FDA approves Incyte's Jakafi XR™ (ruxolitinib) Extended-Release Tablets for the Treatment of Myelofibrosis, Polycythemia Vera and Graft-Versus-Host Disease

FDA approves AstraZeneca's Imfinzi™ (durvalumab) in combination with Bacillus Calmette-Guerin for high-risk non-muscle invasive bladder cancer

FDA approves AbbVie's DECNUPAZ™ (pivekimab sunirine-pvzy) for treatment of adult patients with Blastic Plasmacytoid Dendritic Cell Neoplasm

FDA approves AstraZeneca's ENHERTU–THP as a neoadjuvant therapy for patients with HER2+ (IHC 3+ or ISH+) early breast cancer (Stage II or III)

FDA Approves AstraZeneca's ENHERTU as a post-neoadjuvant treatment for patients with HER2+ (IHC 3+ or ISH+) early breast cancer who have residual invasive disease

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