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FDA Updates for September 2025
On September 25, 2025, the FDA approved imlunestrant (Inluriyo, Eli Lilly and Company), an estrogen receptor antagonist, for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy with efficacy evaluated in EMBER-3 (NCT04975308). Read More
On September 19, 2025, the FDA approved pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) for subcutaneous injection for adult and pediatric (12 years and older) solid tumor indications approved for the intravenous formulation of pembrolizumab (Keytruda, Merck) based in Study MK-3475A-D77 (NCT05722015). Read More
On September 10, 2025, the FDA approved selumetinib (KOSELUGO, AstraZeneca Pharmaceuticals LP) granules and capsules for pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). Read More
On September 9, 2025, the FDA approved gemcitabine intravesical system (Inlexzo, Janssen Biotech, Inc.) for adults with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. Gemcitabine intravesical system is co-packaged with a urinary catheter and stylet used for insertion through the urinary catheter into the bladder based on Cohort 2 of SunRISe-1 (NCT04640623). Read More
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