FDA Grants Accelerated Approval to Datopotamab Deruxtecan-dlnk for EGFR-Mutated Non-Small Cell Lung Cancer

On June 23, the FDA granted accelerated approval to datopotamab deruxtecan-dlnk for adults with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer who have received prior EGFR-directed therapy and platinum-based chemotherapy.

For more information, read the FDA announcement and visit the Daiichi Sankyo website.

Posted on 6/25/2025

FDA Approves Tafasitamab-cxix for Relapsed or Refractory Follicular Lymphoma

On June 18, the FDA approved tafasitamab-cxix with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma.

For more information, read the FDA announcement and the Incyte Corporation press release.

Posted on 6/25/2025

FDA Approves Neoadjuvant and Adjuvant Pembrolizumab for Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma

On June 12, the FDA approved pembrolizumab for adults with resectable locally advanced head and neck squamous cell carcinoma whose tumors express PD-L1 as determined by an FDA-approved test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy with or without cisplatin after surgery, and then as a single agent. 

For more information, read the FDA announcement and the Merck press release.

Posted on 6/17/2025

FDA Approves Mitomycin Intravesical Solution for Recurrent Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer

On June 12, the FDA approved mitomycin intravesical solution for adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer.

For more information, read the FDA announcement and visit the UroGen Pharma website.

Posted on 6/12/2025

FDA Approves Tablet Formulation of Zanubrutinib for All Approved Indications

On June 11, the FDA approved a new tablet formulation of zanubrutinib for all 5 approved indications. 

For more information, visit the BeOne Medicines website.

Posted on 6/12/2025

FDA Approves Taletrectinib for ROS1-positive Non-small Cell Lung Cancer

On June 11, the FDA approved taletrectinib, a kinase inhibitor, for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer.

For more information, read the FDA announcement and the Nuvation Bio press release.

Posted on 6/12/2025

FDA Approves Darolutamide for Metastatic Castration-Sensitive Prostate Cancer

On June 3, the FDA approved darolutamide for metastatic castration-sensitive prostate cancer.

For more information, read the FDA announcement and the Bayer Healthcare Pharmaceuticals Inc press release.

Posted on 6/3/2025

FDA Approves Retifanlimab-dlwr With Carboplatin and Paclitaxel and as a Single Agent for Squamous Cell Carcinoma of the Anal Canal

On May 15, the US Food and Drug Administration (FDA) approved retifanlimab-dlwr 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 retifanlimab-dlwr, as a single agent, for adults with locally recurrent or metastatic SCAC with disease progression on or intolerance to platinum-based chemotherapy.

For more information, read the FDA announcement and the Incyte Corporation press release.

Posted on 5/16/2025

FDA Grants Accelerated Approval to Telisotuzumab Vedotin-tllv for NSCLC With High c-Met Protein Overexpression

On May 14, the US Food and Drug Administration (FDA) granted accelerated approval to telisotuzumab vedotin-tllv, a c-Met-directed antibody and microtubule inhibitor conjugate, for adults with locally advanced or metastatic, non-squamous non-small cell lung cancer with high c-Met protein overexpression, as determined by an FDA-approved test, who have received a prior systemic therapy.

For more information, read the FDA announcement and the AbbVie Inc. press release.

Posted on 5/16/2025

FDA Approves Belzutifan for Pheochromocytoma or Paraganglioma

On May 14, the US Food and Drug Administration (FDA) approved belzutifan for adult and pediatric patients 12 years and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma.

For more information, read the FDA announcement and the Merck & Co., Inc. press release.

Posted on 5/16/2025