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FDA Updates for June 2025
On June 23, 2025, the FDA granted accelerated approval to datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo, Inc.) for adults with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy based on pooled analysis of TROPION-Lung05 (NCT04484142) a multicenter, single-arm trial, and TROPION-Lung01 (NCT04656652) a multicenter, open-label, randomized controlled trial. Read More
On June 18, 2025, the FDA approved tafasitamab-cxix (Monjuvi, Incyte Corporation) with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma (FL) based on inMIND, a double-blind, placebo-controlled trial (NCT04680052) randomizing 548 patients with relapsed or refractory FL to receive tafasitamab-cxix or placebo with lenalidomide and rituximab. Read More
On June 12, 2025, the FDA approved pembrolizumab (Keytruda, Merck) for adults with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin after surgery, and then as a single agent based on KEYNOTE-689 (NCT03765918), a randomized, multicenter, open-label trial in 714 patients with resectable locally advanced (Stage III-IVA) HNSCC [AJCC, 8th edition]. This is the first approval for HNSCC in 6 years and the first overall perioperative approval for locally advanced HNSCC. Read More
On June 12, 2025, the FDA approved mitomycin intravesical solution (Zusduri, UroGen Pharma) for adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) evaluated in ENVISION (NCT05243550), a single-arm, multicenter trial in 240 adults with low-grade NMIBC that recurred after prior transurethral resection of bladder tumor (TURBT) and met 1-2 of the following criteria: multiple tumors, a solitary tumor >3 cm, and/or recurrence within 1 year. Read More
On June 11, 2025, the FDA approved taletrectinib (Ibtrozi, Nuvation Bio Inc.), a kinase inhibitor, for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) based on TRUST-I (NCT04395677) and TRUST-II (NCT04919811), two multicenter, single-arm, open-label clinical trials. Read More
On June 3, 2025, the FDA approved darolutamide (Nubeqa, Bayer Healthcare Pharmaceuticals Inc.) for metastatic castration-sensitive prostate cancer (mCSPC) based on ARANOTE (NCT02799602), a randomized, double-blind, placebo-controlled trial in 669 patients with mCSPC. The FDA previously approved darolutamide in combination with docetaxel for mCSPC. Read More
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