FDA Approves Lurbinectedin in Combination With Atezolizumab or Atezolizumab and Hyaluronidase-tqjs for Extensive-stage Small Cell Lung Cancer

On October 2, the FDA approved lurbinectedin in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs for the maintenance treatment of adult patients with extensive-stage small cell lung cancer whose disease has not progressed after first-line induction therapy with atezolizumab or atezolizumab and hyaluronidase-tqjs, carboplatin, and etoposide.

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

Posted on 10/3/2025

FDA Approves Imlunestrant for ER-positive, HER2-negative, ESR1-mutated Advanced or Metastatic Breast Cancer

On September 25, the FDA approved imlunestrant, an estrogen receptor antagonist, for adults with estrogen receptor-positive, human epidermal growth factor 2-negative, estrogen receptor-1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.

For more information, read the FDA announcement and the Eli Lilly and Company press release.

Posted on 9/26/2025

FDA Approves Pembrolizumab and Berahyaluronidase Alfa-pmph for Subcutaneous Injection

On September 19, the FDA approved pembrolizumab and berahyaluronidase alfa-pmph for subcutaneous injection for adult and pediatric (12 years and older) solid tumor indications approved for the intravenous formulation of pembrolizumab. 

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

Posted on 9/24/2025

FDA Approves Selumetinib for Select Pediatric Patients 1 Year of Age and Older

On September 10, the FDA approved selumetinib granules and capsules for pediatric patients 1 year of age and older with neurofibromatosis type 1 who have symptomatic, inoperable plexiform neurofibromas.

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

Posted on 9/11/2025

FDA Approves Gemcitabine Intravesical System for Non-muscle Invasive Bladder Cancer

On September 9, the FDA approved gemcitabine intravesical system for adults with Bacillus Calmette-Guérin-unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors. Gemcitabine intravesical system is co-packaged with a urinary catheter and stylet used for insertion through the urinary catheter into the bladder.

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

Posted on 9/11/2025

FDA Grants Accelerated Approval to Zongertinib for Non-Squamous NSCLC With HER2 TKD Activating Mutations

On August 8, the FDA granted accelerated approval to zongertinib, a kinase inhibitor, for adults with unresectable or metastatic non-squamous non-small cell lung cancer whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy.

For more information, read the FDA announcement and the Boehringer Ingelheim Pharmaceuticals press release.

Posted on 8/18/2025

FDA Grants Accelerated Approval to Dordaviprone for Diffuse Midline Glioma

On August 6, the FDA granted accelerated approval to dordaviprone, 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.

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

Posted on 8/8/2025

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

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