Sabrina Serani

THE001, a thermosensitive doxorubicin liposome for soft tissue sarcomas, received FDA orphan drug designation, offering development benefits.

The FDA has cleared investigational new drug applications and handed out fast track designations. Plus, data shows promise for novel therapies in hard-to-treat cancers.

The FDA cleared the investigational new drug application of IDE849, a potential first-in-class DLL3-targeted antibody-drug conjugate for solid tumors.

The anti-GD2 therapy naxitamab has been included in the NCCN Clinical Practice Guidelines in Oncology for the treatment of patients with neuroblastoma.

ADRX-0706, a Nectin-4-targeted antibody-drug conjugate, has earned FDA fast track designation in advanced cervical cancer.

T-DXd plus THP led to significant improvements in pathologic complete response in patients with early-stage, HER2+ breast cancer, according to DESTINY-Breast11 data.

The resubmitted biologics license application for narsoplimab in transplant-associated thrombotic microangiopathy has been accepted by the FDA.

With the clinical hold on the tab-cel application lifted, phase 2 and 3 trials of the T-cell immunotherapy in patients with PTLD may resume.

A phase 1b/2 trial in triple-negative breast cancer will assess LP-184 alone and with a PARP inhibitor in advanced cases.

The Wee1 inhibitor adavosertib shows activity in recurrent uterine serous carcinoma, but the drug’s tolerability remains a challenge.

The final ALCYONE analysis with 86.7-month follow-up shows daratumumab-VMP significantly improved overall survival in transplant-ineligible, newly diagnosed multiple myeloma.

David Polsky, MD, discussed a study showing ctDNA levels before melanoma treatment strongly predict recurrence and its speed, potentially guiding future therapy decisions.

Sofia Chernoff, PsyD, MSEd, discussed how cognitive behavioral therapy helps cancer patients manage emotional challenges by modifying negative thoughts and behaviors.

A post hoc analysis shows significantly improved ORR and PFS in advanced NSCLC with higher AFM24 exposure, supporting optimized dosing strategies.

The FDA requires more data to approve the application of TLX101-CDx for the detection and differentiation of glioma.

Following clearance from the FDA, a phase 1/2 study will assess OBI-902 in Trop-2-overexpressing solid tumors, with plans for enrollment to begin later this year.

Updated findings from a phase 2 study investigating the IL-2–binding monoclonal antibody AU-007 show a manageable safety profile with strong antitumor evidence.

Reduced-dose radiotherapy in head & neck cancer shows similar efficacy to standard dose but with lower toxicity, per findings from the UPGRADE-RT trial.

Antibody-drug conjugates continue to show benefits in breast cancer, plus the FDA has fast-tracked an innovative AI tool to help identify pancreatic tumors.

Enfortumab vedotin plus pembrolizumab followed by surgery showed high complete response rates in advanced urothelial cancer.

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.

Ivonescimab plus chemotherapy improved survival in advanced squamous NSCLC vs tislelizumab and chemotherapy in a phase 3 trial.

The DESTINY-Breast09 trial showed that first-line fam-trastuzumab deruxtecan plus pertuzumab improved progression-free survival in HER2+ metastatic breast cancer.

The week marked several FDA approvals for drugs and devices, plus data continues to show tarlatamab’s benefit in small cell lung cancer.

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

Bexmarilimab and azacitidine showed continued tolerability and a high overall response rate in relapsed/refractory higher-risk myelodysplastic syndromes in a phase 2 study.

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

The first patient in a phase 2 clinical trial evaluating 67Cu-SAR-bisPSMA for patients with metastatic castration-resistant prostate cancer has been dosed.