Jordyn Sava

In an interview, Cedric Pobel, MD, further discussed the PEACE-1 trial and its findings.

FoundationOne CDx is now FDA-approved as the first companion diagnostic for tovorafenib, enabling targeted treatment for relapsed/refractory pediatric low-grade glioma with BRAF mutations or rearrangements.

The approval of this combination is supported by data from the phase 3 CodeBreaK 300 study.

Acalabrutinib with bendamustine and rituximab is now an FDA-approved treatment for patients with previously untreated mantle cell lymphoma.

The FDA has issued a complete response letter to the biologics license application seeking the approval of tabelecleucel for Epstein-Barr virus–positive post-transplant lymphoproliferative disease treatment.

Axatilimab has gained FDA approval in 9 mg and 22 mg vials, expanding treatment options for patients with chronic GVHD after 2 prior therapy failures.

The FDA has approved the investigational new drug application of 225Ac-SSO110, allowing for the start of a phase 1/2 trial in patients with extensive-stage small cell lung cancer and Merkel cell carcinoma.

An FDA application for TAR-200 to treat BCG-unresponsive high-risk non-muscle-invasive bladder cancer is under real-time oncology review, expediting access to this potential treatment.

The FDA set August 29, 2025, as the PDUFA date for the 3-month leuprolide mesylate formulation, supported by phase 3 trial data.

In this episode of Targeted Talks, Sanjay K. Juneja, MD, discusses the exciting advancements of artificial intelligence in 2024.

The FDA granted priority review to datopotamab deruxtecan in advanced EGFR-mutated NSCLC after prior therapies, with a decision expected by July 12, 2025.

R-5780, an oral immuno-oncology drug designed to activate gut-regulated immune pathways, will now be evaluated in a phase 1 trial for cancer treatment.

Enrollment in the LOTIS-5 trial of loncastuximab tesirine-lpyl with rituximab in patients with relapsed/refractory diffuse large B-cell lymphoma has been completed.

The C-POST trial has shown cemiplimab to significantly improve disease-free survival in patients with high-risk cutaneous squamous cell carcinoma following surgery.

LYT-200 now has gained fast track designation from the FDA in acute myeloid leukemia in addition to its prior designation for recurrent or metastatic head and neck squamous cell carcinoma.

The phase 2 trial showed a 42% response rate with lete-cel in synovial sarcoma and MRCLS, with manageable adverse events.

BBO-8520, an investigational oral agent, has been granted fast track designation from the FDA in previously treated KRAS G12C–mutated metastatic non–small cell lung cancer.

The FDA has granted fast track designation to emiltatug ledadotin for advanced or metastatic breast cancer treatment, as supported by new phase 1 data.

The investigational new drug application for the nanoparticle drug SNB-101 has been cleared for small cell lung cancer treatment.

R289 has gained orphan drug status from the FDA for the treatment of patients with myelodysplastic syndromes.

The phase 3 ARES study of MaaT013 in patients with acute GVHD with gastrointestinal involvement met its primary end point of overall response rate at day 28.

The phase 3 IRAKLIA trial of subcutaneous isatuximab met its co-primary end points in multiple myeloma.

David Sallman, MD, Moffitt Cancer Center, discussed the trial's impact and the future role of MRD monitoring in treatment strategies for TP53-mutant MDS and AML.

TYRA-300 has gained an investigational new drug application from the FDA and will be further studied in the phase 2 SURF302 trial for patients with low-grade, intermediate-risk non–muscle-invasive bladder cancer.

Post-operative nivolumab significantly improved disease-free survival in resected locally advanced head and neck cancer, meeting the primary end point of the phase 3 NIVOPOSTOP trial.

The NRG-HN004 trial showed that durvalumab did not improve outcomes vs cetuximab in locoregionally advanced head and neck squamous cell carcinoma undergoing radiotherapy with contraindications to cisplatin, leading to early trial closure.

A draft guidance from the FDA outlines criteria for confirmatory trials in accelerated approvals, emphasizing timely initiation, sponsor engagement, and new mandates for oncology treatments.

Invikafusp alfa has gained FDA fast track designation for treating TMB-H metastatic colorectal cancer.

Joe DePinto, MBA, discussed the findings of the McKesson 2024 Cell and Gene Therapy Report, providing insight into the challenges and opportunities in equitable access to these treatments.

The FDA granted orphan drug designation to amezalpat in hepatocellular carcinoma based on phase 1b/2 data showing efficacy and safety with atezolizumab and bevacizumab in frontline treatment.