FDA Approves Revumenib for Relapsed or Refractory Acute Myeloid Leukemia With a Susceptible NPM1 Mutation

On October 24, the FDA approved revumenib, a menin inhibitor, for relapsed or refractory acute myeloid leukemia with a susceptible nucleophosmin 1 mutation in adult and pediatric patients 1 year and older who have no satisfactory alternative treatment options.

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

Posted on 10/27/2025

FDA Approves Belantamab Mafodotin-blmf for Relapsed or Refractory Multiple Myeloma

On October 23, the FDA approved belantamab mafodotin-blmf, a B-cell maturation antigen-directed antibody and microtubule inhibitor conjugate, with bortezomib and dexamethasone for adults with relapsed or refractory multiple myeloma who have received at least 2 prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.

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

Posted on 10/27/2025

Abemaciclib Shows Prolonged Survival in HR+, HER2-, High-risk Early Breast Cancer With 2 Years of Treatment

Eli Lilly and Company announced results from the primary overall survival analysis of the Phase 3 monarchE trial showing that 2 years of adjuvant abemaciclib plus endocrine therapy (ET) reduced the risk of death by 15.8% versus ET alone and resulted in sustained long-term improvements in invasive disease-free survival and distant relapse-free survival in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-positive, high-risk early breast cancer.

For more information, read the Eli Lilly press release.

Posted on 10/27/2025

FDA Approves Cemiplimab-rwlc for Adjuvant Treatment of Cutaneous Squamous Cell Carcinoma

On October 8, the FDA approved cemiplimab-rwlc for the adjuvant treatment of adults with cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation.

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

Posted on 10/9/2025

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