The FDA on August 8, 2025, granted accelerated approval to HERNEXEOS®, a kinase inhibitor, for adults with unresectable or metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy. HERNEXEOS® is a product of Boehringer Ingelheim Pharmaceuticals, Inc.
Author: RR
MODEYSO® (Dordaviprone)
The FDA on August 6, 2025, granted accelerated approval to MODEYSO®, a protease activator, for adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy. MODEYSO® is a product of Jazz Pharmaceuticals, Inc.
ZEGFROVY® (Sunvozertinib)
The FDA on July 2, 2025, granted accelerated approval to ZEGFROVY® for adult patients with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. ZEGFROVY® is a product of Dizal (Jiangsu) Pharmaceutical Co., Ltd.
LYNOZYFIC® (Linvoseltamab-gcpt)
The FDA on July 2, 2025, granted accelerated approval to LYNOZYFIC®, a bispecific B-Cell Maturation Antigen (BCMA)-directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a Proteasome Inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody. LYNOZYFIC® is a product of Regeneron Pharmaceuticals, Inc.
DATROWAY® (Datopotamab deruxtecan-dlnk)
The FDA on June 23, 2025, granted accelerated approval to DATROWAY® 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. DATROWAY® is a product of Daiichi Sankyo, Inc.
MONJUVI® (Tafasitamab-cxix)
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.
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.