April 2025 Brief

A pilot study will evaluate Alpha DaRT for the treatment of patients with recurrent glioblastoma.

Following a successful Type B end-of-phase 2 meeting, the FDA has approved the start of a phase 3 trial of linperlisib in peripheral T-cell lymphoma.

Paige PanCancer Detect has gained FDA breakthrough device designation, a first for AI identifying diverse cancers across tissues.

The FDA cleared the investigational new drug application for ALX2004, with phase 1 trials expected to begin in mid-2025 for EGFR+ solid tumors.

Ziftomenib’s FDA application for relapsed/refractory NPM1-mutant acute myeloid leukemia is supported by data from the KOMET-001 trial.

ST-001, an intravenous nanoformulation of fenretinide, will be evaluated in a phase 1a/1b small cell lung cancer trial.

Based on data from the phase 3 CheckMate-8HW trial, the combination of nivolumab and ipilimumab has been approved by the FDA in metastatic colorectal cancer.

The FDA has granted 501(k) clearance to ZEISS INTRABEAM 700, a robotic-assisted platform designed to enhance intraoperative radiation therapy.

The FDA has fully approved larotrectinib for adult and pediatric patients with solid tumors that harbor an NTRK gene fusion.

The FDA has approved bevacizumab-nwgd, a biosimilar to bevacizumab, for intravenous use across multiple cancer types.

Following a recent Type D meeting with the FDA, a phase 3 clinical trial design for darovasertib in primary uveal melanoma has been announced.

A supplemental biologics license application has been submitted to the FDA for nogapendekin alfa plus Bacillus Calmette-Guérin in papillary non-muscle invasive bladder cancer.

The FDA granted regenerative medicine advanced therapy designation to iltamciocel for patients with oropharyngeal dysphagia following head and neck cancer treatment.

The FDA has granted clearance to an investigational new drug application for CLD-201 for solid tumor treatment, based on preclinical findings.

The DAMO PANDA can accurately detect pancreatic cancer lesions, and FDA breakthrough therapy designation aims to accelerate its development and approval.

FDA designates BCB-276 as a breakthrough therapy for pediatric DIPG, offering hope for improved treatment of this challenging brain tumor.

Phase 1 trial of TGW101 in advanced solid tumors is enrolling to assess safety and pharmacokinetics and define the maximum tolerated dose in up to 50 patients.

EvoLiver, a blood test that detects early-stage liver cancer with high accuracy, has gained breakthrough device designation from the FDA.

The FDA has approved penpulimab with chemotherapy for first-line recurrent/metastatic non-keratinizing nasopharyngeal carcinoma and alone after prior treatment.

With the clearance of an investigational new drug application from the FDA, a phase 1/2a study will evaluate VS-7375 in KRAS G12D-mutant solid tumors.