The FDA on June 18, 2025, approved MONJUVI® with Lenalidomide and Rituximab for adults with relapsed or refractory Follicular Lymphoma (FL). MONJUVI® is a product of Incyte Corporation.
Category: FDA Approvals
KEYTRUDA® (Pembrolizumab)
The FDA on June 12, 2025, approved KEYTRUDA® 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. KEYTRUDA® is a product of Merck.
ZUSDURI® (Mitomycin intravesical solution)
The FDA on June 12, 2025, approved ZUSDURI® for adult patients with recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (LG-IR-NMIBC). ZUSDURI® is a product of UroGen Pharma.
IBTROZI® (Taletrectinib)
The FDA on June 11, 2025, approved IBTROZI®, a kinase inhibitor, for adults with locally advanced or metastatic ROS1-positive Non-Small Cell Lung Cancer (NSCLC). IBTROZI® is a product of Nuvation Bio Inc.
NUBEQA® (Darolutamide)
The FDA on June 3, 2025, approved NUBEQA® for metastatic Castration-Sensitive Prostate Cancer (mCSPC). The FDA previously approved NUBEQA® in combination with Docetaxel for mCSPC. NUBEQA® is a product of Bayer Healthcare Pharmaceuticals Inc.
ZYNYZ® (Retifanlimab-dlwr)
The FDA on May 15, 2025, approved ZYNYZ® with Carboplatin and Paclitaxel for the first-line treatment of adults with inoperable locally recurrent or metastatic Squamous Cell Carcinoma of the Anal Canal (SCAC). The FDA also approved ZYNYZ®, as a single agent, for adults with locally recurrent or metastatic SCAC with disease progression on or intolerance to Platinum-based chemotherapy. ZYNYZ® is a product of Incyte Corporation.
EMRELIS® (Telisotuzumab vedotin-tllv)
The FDA on May 14, 2025, granted accelerated approval to EMRELIS®, a c-Met-directed antibody and microtubule inhibitor conjugate, for adults with locally advanced or metastatic, non-squamous Non-Small Cell Lung Cancer (NSCLC) with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test, who have received a prior systemic therapy. EMRELIS® is a product of AbbVie Inc.
AVMAPKI® (Avutometinib) and FAKZYNJA® (Defactinib) Co-pack
The FDA on May 8, 2025, granted accelerated approval to the combination of AVMAPKI® and FAKZYNJA® Co-pack, for adult patients with KRAS-mutated recurrent Low-Grade Serous Ovarian Cancer (LGSOC) who have received prior systemic therapy. AVMAPKI® and FAKZYNJA® are products of Verastem, Inc.
Penpulimab-kcqx
The FDA on April 23, 2025, approved Penpulimab-kcqx with Cisplatin or Carboplatin and Gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing NasoPharyngeal Carcinoma (NPC). Penpulimab-kcqx is a product of Akeso Biopharma Co., Ltd.