Brain Cancer

SH-110 received orphan drug designation from the FDA for the treatment of patients with glioma.

The FDA granted orphan drug designation to MB-101 for recurrent diffuse and anaplastic astrocytoma and glioblastoma.

Long-term survival signals with Temferon in 2 patients with newly diagnosed glioblastoma multiforme suggest potential mediation of disease progression.

The FDA grants approval to Dato-DXd in EGFR+ NSCLC, revumenib sNDA is under priority review for NPM1-mutant AML, and more from OncLive this week.

The FDA granted fast track designation to RAD101 for imaging of cerebral metastases from various solid tumors, including leptomeningeal metastases.

Data from the phase 1 CLOVER-2 trial demonstrated the safety and activity of iopofosine I-131 in relapsed/refractory pediatric high-grade glioma.

Read a recap of the episodes of OncLive On Air that debuted in May 2025.

Ryan T. Merrell, MD, discusses current treatment modalities for gliomas in recognition of Brain Tumor Awareness Month.

Ryan Merrell, MD, underscores the need for early glioma detection, advances in IDH-targeted therapy, and emerging immunotherapy in glioblastoma care.

The EMA’s CHMP has issued a positive opinion for mirdametinib for pediatric and adult patients with NF1-associated plexiform neurofibromas.

CNS Pharmaceuticals has acquired the orphan drug designations for TPI 287 in gliomas, pediatric neuroblastoma, and progressive supranuclear palsy.

The B7-H3–directed CAR T-cell therapy BCB-276 received RMAT designation for the treatment of patients with diffuse intrinsic pontine glioma.

The novel injectable radiotherapy 186RNL showed safety and clinical activity as treatment for patients with leptomeningeal metastases.

The ongoing phase 2B SURVIVE clinical trial of SurVaxM in glioblastoma will continue following an interim analysis of trial data.

The NCCN guidelines now recommend a naxitamab-based regimen for high-risk neuroblastoma.

The FDA issues a CRL to a glioma imaging agent, an sBLA seeking approval of an epcoritamab triplet in follicular lymphoma is planned for submission, and more.

The FDA issued a complete response letter to the new drug application seeking the approval of TLX101-CDx as an imaging agent for glioma.

The FDA granted breakthrough therapy designation to BCB-276 for pediatric diffuse intrinsic pontine glioma.

TLX101 was associated with a favorable safety profile and preliminary signs of clinical activity in patients with recurrent high-grade glioma.

The bevacizumab biosimilar Jobevne was approved by the FDA for the treatment of several solid tumor types, including mCRC, NSCLC, and RCC.

The ZEISS INTRABEM 700 platform received 510(k) clearance from the FDA for use in neuro-oncology and breast cancer surgery.

William Kelly, MD, discusses the safety and efficacy signals seen with sacituzumab govitecan in a phase 2 study of patients with recurrent glioblastoma.

The combination of VXM01 and avelumab was well tolerated and has the potential to generate clinically meaningful responses in recurrent glioblastoma.

NEO100 was given rare pediatric disease designation by the FDA for the treatment of patients with pediatric-type diffuse high-grade glioma.

Georges Ayoub, MD, MS, discusses how a supervised deep-learning model trained with expert-labeled data seeks to improve interpretability and diagnostic precision in glioblastoma morphological analysis.