Jordyn Sava is an editor for Targeted Oncology.
FDA Grants Orphan Drug Designation to PEP-010 in Pancreatic Cancer
PEP-010 was granted FDA orphan drug designation for the treatment of pancreatic cancer.
FDA OKs TLX007-CDx in Prostate Cancer Treatment
TLX007-CDx is now an FDA-approved PSMA PET imaging agent in prostate cancer.
FDA Updates Decision on ProSense Cryoablation for Early-Stage Breast Cancer
The FDA has extended its review of the ProSense cryoablation system for early-stage breast cancer, with a decision expected after the first quarter of 2025.
ST316 Shows Promise in Phase 1 Trial for Wnt/β-Catenin-Driven Cancers
ST316, a β-catenin/BCL9 antagonist, demonstrated safety, target engagement, and early antitumor activity in advanced solid tumors.
FDA Grants Standard Approval to Pembrolizumab Plus Trastuzumab/Chemo for HER2+, PD-L1+ Gastric Cancer
The combination of pembrolizumab, trastuzumab, and chemotherapy is now approved in HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma.
FDA Grants Orphan Drug Designation to HLX22 for Gastric Cancer Treatment
The FDA granted orphan drug designation to HLX22 for gastric cancer, advancing global phase 3 trials to improve first-line treatment.
Tarlatamab Demonstrates Positive Benefit-Risk Profile in SCLC
Tarlatamab showed a positive benefit-risk profile in small cell lung cancer, per the phase 2 DeLLphi-301 study.
FDA Backs Phase 3 Trial of Pro-ocular for Ocular GVHD Treatment
A phase 3 trial plans to evaluate Pro-ocular for the treatment of patients with ocular graft-vs-host disease.
Dr Long Highlights Long-Term Benefit of Dabrafenib/Trametinib in Melanoma
Georgina V. Long, MD, MSc, discussed the long-term follow-up data for the combination of adjuvant dabrafenib and trametinib in stage III BRAF-mutated melanoma.
Bexobrutideg Gains FDA Orphan Drug Status in Waldenström Macroglobulinemia
Bexobrutideg, a first-in-class Bruton’s tyrosine kinase degrader, has been granted orphan drug designation from the FDA in Waldenström macroglobulinemia.
Amivantamab/Lazertinib Efficacy in EGFR+ NSCLC Sustained in MARIPOSA Follow-Up
Shirish M. Gadgeel, MD, discussed long-term data from the MARIPOSA trial of lazertinib and amivantamab in EGFR-mutated non–small cell lung cancer.
Mirvetuximab Shows Lasting Survival Benefit in Resistant Ovarian Cancer
Toon Van Gorp, MD, PhD, discussed findings from the MIRASOL trial and the potential of mirvetuximab to redefine treatment paradigms in ovarian cancer.
Orca-T Improves cGVHD-Free Survival Across Hematologic Malignancies
Orca-T improved 1-year survival without severe graft-vs-host disease compared with standard transplant in the Precision-T study.
Phase 3 Trial of the ArteraAI Prostate Test Begins Enrollment
The first patient has been enrolled in the PROSTATE-IQ trial of ArteraAI, a multimodal artificial intelligence biomarker test.
Overcoming Challenges in Adopting Epigenetic Liquid Biopsy for Prostate Cancer
Jacob E. Berchuck, MD, highlights challenges in adopting liquid biopsy for PSMA expression and its potential to revolutionize precision medicine in prostate cancer.
Trial of ARC101 Doses First Patient With CLDN6+ Solid Tumors
ARC101, a potential best-in-class T-cell engager that targets solid tumors expressing CLDN6, is being assessed in a first-in-human trial.
Kato Breaks Down FDA Approval of Tislelizumab in Esophageal Cancer
Ken Kato, MD, discussed the FDA approval of tislelizumab for the first-line treatment of esophageal squamous cell carcinoma.
Organ-Sparing TMLI Enhances AML Transplant Outcomes
Anthony Stein, MD, assessed total marrow and lymphoid irradiation with post-transplant cyclophosphamide in patients with acute myeloid leukemia.
Novel rhPSMA Therapy Targets Advanced Prostate Cancer With Precision
177Lu rhPSMA-10.1 showed high tumor radiation with low healthy tissue exposure in a phase 1/2 trial for metastatic castration-resistant prostate cancer.
BMT CTN 1902 in Myeloma: Key Findings With Garfall
In this episode of Targeted Talks, Alfred L. Garfall, discusses the phase 2 BMT CTN 1902 trial of idecabtagene vicleucel in patients with multiple myeloma.
Actimab-A Triplet Trial Launches in Frontline AML
A phase 1 trial is evaluating Actimab-A, venetoclax, and ASTX-727 in frontline acute myeloid leukemia, with initial data expected later this year.
HER2DX Test Transforms Treatment Decisions in HER2+ Breast Cancer
A real-world study showed HER2DX guided treatment changes in approximately 48% of HER2-positive breast cancer cases.
Phase 2 Trial of OSE2101 in Advanced PDAC Meets Primary End Point
The TEDOPaM trial evaluating a novel maintenance therapy approach for advanced/metastatic pancreatic ductal adenocarcinoma has met its primary end point.
Odronextamab Shows Efficacy in DLBCL Post CAR T-Cell Therapy
Matthew Matasar, MD, discussed what the findings from the ELM-1 trial of odronextamab in diffuse large B-cell lymphoma mean for oncologists.
Evofosfamide Trial Targets Hypoxia in Resistant Solid Tumors
The first patient was dosed in a phase 1/2 trial of evofosfamide with checkpoint inhibitors for hypoxia-reversal in resistant solid tumors.
FDA Clears Phase 1 Trial of MRANK-106 in Advanced Solid Tumors
The FDA cleared the investigational new drug application for MRANK-106, a dual WEE1/YES1 kinase inhibitor, targeting advanced solid tumors.
BREAKWATER Trial Highlights ORR Boost in BRAF V600E mCRC
For Colorectal Cancer Awareness Month, Scott Kopetz, MD, PhD, FACP, discussed the BREAKWATER trial in metastatic BRAF V600E-mutated colorectal cancer.
FDA Grants Rhenium Obisbemeda Orphan Drug Status for LM in Lung Cancer
The FDA granted orphan drug status to rhenium-186 obisbemeda for treating leptomeningeal metastases in lung cancer.
Durvalumab Plus Chemotherapy Boosts EFS in Gastric/GEJ Cancer
MATTERHORN is the first global phase 3 trial to show improved event-free survival with an immunotherapy combo vs standard care in this patient population.
Cutting Delays in Cancer Care With Centralized Prior Authorizations
Andrea Ledford, PharmD, MBA, BCOP, BCSCP, FASHP, FHOPA, discussed a comprehensive pharmacy program presented at the 2025 ACCC Annual Meeting & Cancer Center Business Summit.