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FDA Grants Rare Pediatric Disease Designation to Galinpepimut-S in AML
The FDA granted galinpepimut-S a rare pediatric disease designation for the treatment of pediatric patients with acute myeloid leukemia.
KEYNOTE-522 Trial: Pembrolizumab Boosts Survival in Early TNBC
Peter Schmid, MD, PhD, discusses the background, methods, and design of the phase 3 KEYNOTE-522 trial.
AI Tools for Accurate Cancer Diagnosis and Tailored Treatment
Anil Parwani, MD, PhD, discusses how he sees artificial intelligence technology contributing to personalized medicine and helping to tailor treatment plans for individual patients in the future.
FDA Clears NDA of Intravesical Mitomycin in Non–Muscle-Invasive Bladder Cancer
A Prescription Drug User Fee Act target action date of June 13, 2025, has been set for the new drug application of intravesical mitomycin.
Acclaim-3 Trial Escalates Quaratusugene Ozeplasmid/Atezolizumab Dosing in SCLC
The 0.09 mg/kg dose group of the phase 1 dose-escalation portion of the Acclaim-3 study in extensive-stage small cell lung cancer is completed.
FDA Oks Optune Lua for Use With PD-1/PD-L1 Inhibitors in Metastatic NSCLC
Following promising results from the phase 3 LUNAR trial, the FDA has approved Optune Lua for use with PD-1/PD-L1 inhibitors or docetaxel in patients with metastatic non–small cell lung cancer.
IMforte Shows Benefits of Lurbinectedin/Atezolizumab in ES-SCLC
A new combination therapy of lurbinectedin and atezolizumab showed promising results in improving overall survival and progression-free survival in extensive-stage small cell lung cancer.
Teclistamab Shows 100% Response Rate in High-Risk Smoldering Myeloma
In an interview with Targeted Oncology, Omar Nadeem, MD, discussed the first results from the Immuno-PRISM study in patients with high-risk smoldering myeloma.
FDA Provides Positive Feedback on AMPLIFY Trial for Prostate Cancer Diagnostic
The phase 3 trial AMPLIFY study plans to test the diagnostic performance of 64Cu-SAR-bisPSMA PET/CT imaging in approximately 220 patients with prostate cancer with biochemical recurrence.
FDA Clears IND of Novel ADC in AML Treatment
BL-M11D1, a CD33-binding antibody-drug conjugate, is being evaluated for the treatment of patients with acute myeloid leukemia.
Shifting the Paradigm: Challenges, Opportunities and Methodologies in Studying Rare Cancers
The study of rare cancers has undergone a paradigm shift, transitioning from a singular disease entity approach to a more nuanced understanding of biomarker-defined subtypes.
Empowering Women Through Early Breast Cancer Detection: Taking Control of Your Health
For Breast Cancer Awareness Month, Deborah Toppmeyer, MD, emphasizes the crucial role of early breast cancer detection.
The Targeted Pulse: Uncover Essential Developments in Breast Cancer, Multiple Myeloma, and NSCLC Treatment and the Latest FDA Approvals
Cologuard Plus test receives FDA approval, understanding genomic profiling leads to advanced personalized care in breast cancer, and a new CAR T therapy is making waves in multiple myeloma.
Bringing Bispecific Antibody Therapy to Community Oncology Centers
In an interview with Targeted Oncology, Courtney Van Houzen, PharmD, shared her experience in bringing bispecific antibody treatments to a community setting.
Advancements In Obesity Treatment and How This May Impact Cancer In The Future
John M. Burke, MD, examines how new obesity treatments, such as GLP-1 agonists, might influence future cancer rates.
Long-Term Success With Anti–LAG-3/Anti–PD-1 Combo in Metastatic Melanoma
Meredith McKean, MD, MPH, discussed findings from a longer-term follow-up study evaluating fianlimab plus cemiplimab for the treatment of metastatic melanoma.
FDA Approves Inavolisib Plus Standard Therapy in PIK3CA-Mutant Breast Cancer
The approval of inavolisib is supported by findings from the phase 3 INAVO120 study evaluating the agent plus palbociclib and fulvestrant.
Talazoparib/Enzalutamide Combo Offers Significant Survival Benefits in Prostate Cancer
According to findings from the TALAPRO-2 study, the combination led to significant and meaningful improvements in overall survival vs enzalutamide monotherapy.
Eric Cheung: Competence and Compassion are Key to Earning Patients' Trust
Eric Cheung, DO, Targeted Oncology’s second 2024 Oncology Icon, discussed his journey in oncology, advances in treatment, and his patient-centered approach to care.
FDA Oks Aquablation vs Prostatectomy Trial in Localized Prostate Cancer
The FDA has approved the WATER IV PCa trial, which will compare the safety and efficacy of Aquablation therapy to radical prostatectomy in patients with localized prostate cancer.
Trial of PT886 and Pembrolizumab Doses First Patient With Gastric/GEJ Cancer
The first patient with advanced gastric and gastroesophageal cancer has been dosed in a trial combining PT886 with pembrolizumab.
Liu’s Insights on Navigating the Fragility of Phase 3 Trials
Yufei Liu, MD, PhD, discussed the importance of careful data interpretation to accurately assess the efficacy of new treatment options in oncology.
Namodenoson Earns FDA Orphan Drug Designation in Pancreatic Cancer
The sponsor is preparing a phase 2 study to evaluate namodenoson in this patient population.
Detecting PSMA in Prostate Cancer Noninvasively With Liquid Biopsy
Jacob E. Berchuck, MD, discussed research behind using a blood-based liquid biopsy in prostate cancer and findings presented at the 2024 ESMO Congress.
SunRISe-2 Study of TAR-200 Plus Cetrelimab in MIBC Discontinues
The SunRISe-2 trial evaluating TAR-200 combined with cetrelimab vs chemoradiation in muscle-invasive bladder cancer has been discontinued.
STX-241 Trial Begins for EGFR TKI-Resistant NSCLC Treatment
The first patient in a phase 1/2 trial investigating a novel agent for the treatment of non–small cell lung cancer has been dosed.
VLS-1488 Gains FDA Fast Track Status in Advanced Ovarian Cancer
The FDA has granted VLS-1488 fast track designation in patients with platinum-resistant high-grade serous ovarian cancer.
Perioperative Pembrolizumab Betters Survival in Stage III/IV Head and Neck Cancer
The KEYNOTE-689 study evaluating pembrolizumab in this patient population met its primary end point of event-free survival.
Long-Term Data Confirms Cemiplimab Benefits in High PD-L1 NSCLC
Ana Baramidze, MD, PhD, discussed 5-year follow-up results from the EMPOWER-Lung study evaluating cemiplimab vs chemotherapy in advanced first-line non–small cell lung cancer.
Merchan’s Takeaways From the CLEAR Study in Advanced RCC
Jaime Merchan, MD, discusses what the potential clinical implications or takeaways for colleagues are based on findings from the phase 3 CLEAR study in advanced renal cell carcinoma (RCC).