June 2025 Brief

If approved, ziftomenib could be the first FDA-approved Menin inhibitor for relapsed/refractory acute myeloid leukemia with an NPM1 mutation.

Darolutamide is now an FDA-approved treatment option alone or in combination with docetaxel for metastatic castration-sensitive prostate cancer.

A new FDA application for vepdegestrant offers hope for advanced breast cancer patients with ESR1 mutations, showcasing promising trial results.

TuHURA Biosciences advances its phase 3 trial of IFx-2.0 for Merkel cell carcinoma, aiming to enhance immune response alongside pembrolizumab.

FDA prioritizes review of lurbinectedin and atezolizumab for first-line maintenance therapy in extensive-stage small cell lung cancer, promising improved survival rates.

The FDA granted fast track designation to PHST001 for the treatment of advanced ovarian cancer.

Taletrectinib gains FDA approval as a groundbreaking treatment for ROS1-positive non-small cell lung cancer, offering hope for patients with CNS involvement.

The FDA has approved a tablet version of zanubrutinib for all indications, improving convenience and reducing pill burden for patients with blood cancers.

The FDA approved intravesical mitomycin in non–muscle-invasive bladder cancer as an nonsurgical alternative to transurethral resection of bladder tumors.

The FDA has granted approval to pembrolizumab for the treatment of adult patients with resectable, locally advanced HNSCC whose tumors express PD-L1 with a CPS of ≥1.

Myrio's PHOX2B PC-CAR T therapy gains FDA approval for human trials, promising innovative treatment for patients with high-risk neuroblastoma.

FDA updates talazoparib and enzalutamide labeling, confirming survival benefits for HRR-mutated mCRPC, while excluding non-HRR patients.

Tafasitamab-cxix gains FDA approval for relapsed follicular lymphoma, showcasing significant progression-free survival benefits in combination therapy.

SENTI-202, a groundbreaking CAR NK-cell therapy, targets relapsed/refractory AML, offering hope for patients with limited treatment options.

Christina Poh, MD, discusses the recent FDA approval of tafasitamab plus lenalidomide and rituximab in relapsed/refractory follicular lymphoma.

FDA clears lonitoclax for a phase 1 trial in relapsed/refractory AML, promising improved safety and efficacy over existing therapies.

FDA accelerates approval of datopotamab deruxtecan for advanced EGFR-mutated NSCLC, offering new hope for previously treated patients.

FDA prioritizes review of revumenib for relapsed NPM1-mutant AML, highlighting a breakthrough in targeted cancer therapies.

Detalimogene voraplasmid gains FDA RMAT designation, showcasing a 71% response rate in treating high-risk, BCG-unresponsive NMIBC with promising safety.

FDA updates CAR T-cell therapy labels, easing monitoring requirements and expanding access for eligible patients in oncology.

FDA approves tafasitamab with lenalidomide and rituximab, offering a groundbreaking chemotherapy-free treatment for relapsed follicular lymphoma.

Daraxonrasib gains FDA breakthrough therapy status for treating metastatic pancreatic cancer with KRAS G12X mutations, showing promising survival rates.