Industry News

FDA Approves Streamlined Patient Monitoring Requirements and Removal of REMS Programs Within Bristol Myers Squibb’s Cell Therapy Labels

On June 26, the FDA approved label updates for both of Bristol Myers Squibb's CAR T-cell therapies: lisocabtagene maraleucel (liso-cel) for the treatment of large B cell lymphoma and other lymphomas and idecabtagene vicleucel (ide-cel) for the treatment of multiple myeloma. These label updates reduce certain patient monitoring requirements and remove the risk evaluation and mitigation strategy programs that had been in place since each product was initially approved.
For more information, read the Bristol Myers Squibb press release.
Posted on 7/7/2025

FDA Grants Accelerated Approval to Sunvozertinib for Metastatic Non-Small Cell Lung Cancer

On July 2, the FDA granted accelerated approval to sunvozertinib for adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
For more information, read the FDA announcement and visit the Dizal (Jiangsu) Pharmaceutical website.
Posted on 7/7/2025

FDA Grants Accelerated Approval to Linvoseltamab-gcpt for Relapsed or Refractory Multiple Myeloma

On July 2, the FDA granted accelerated approval to linvoseltamab-gcpt, a bispecific B-cell maturation antigen-directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma who have received at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
For more information, read the FDA announcement and the Regeneron Pharmaceuticals press release.
Posted on 7/2/2025

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