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FDA Grants Priority Review to NDA of Nirogacestat for Desmoid Tumors
February 27th 2023Data from the phase 3 DeFi trial showed that nirogacestat led to a 71% reduction in the risk of disease progression compared with placebo for adult patients with desmoid tumors. Now, the FDA has granted a priority review to the new drug application for nirogacestat.
Discussing the Long-term Impacts of Darolutamide in Nonmetastatic CRPC
February 26th 2023Discussing his presentation from the 2023 ASCO Genitourinary Symposium, Neal Shore, MD, FACS, looks at the long-term results of the phase 3 ARAMIS study for patients with nonmetastatic castration-resistant prostate cancer on darolutamide.
Emerging Data Behind 2 Antibody Drug Conjugates for Breast and Prostate Cancer
February 24th 2023Experts addressed ARX788 for patients with HER2-positive breast cancer, and a data update from the update for APEX-01 evaluating ARX517 in patients with prostate cancer was provided during a virtual analyst and investor day.
FDA Okays IND Application of BA3182 for Advanced Adenocarcinoma
February 24th 2023A phase 1 dose-escalation and -expansion clinical trial will evaluate BA3182, a potential anticancer therapy, for patients with advanced adenocarcinoma based on the clearance of an investigational new drug application from the FDA.
Pembrolizumab Plus Chemo Emerges as New Option for Advanced, HER2–Negative Gastric/GEJ Cancer
February 23rd 2023A read out from the phase 3 KEYNOTE-859 at the February ESMO Virtual Plenary hints pembrolizumab/chemotherapy is a new treatment choice for locally advanced or metastatic, HER2-negative gastric or gastroesophageal junction adenocarcinoma.
Briquilimab/Low-Dose TBI/Fludarabine Shows Promise in MDS/AML Undergoing AlloHCT
February 23rd 2023In an interview with Targeted Oncology, Lori Muffly, MD, discusses the subanalysis of a phase 1 study of briquilimab plus low-dose total body radiation and fludarabine which was presented at 2023 Tandem Meetings on Transplantation and Cellular Therapy.
FDA Greenlights BTD of a Personalized mRNA Vaccine for High-Risk Melanoma
February 23rd 2023The FDA has granted a breakthrough therapy designation to mRNA-4157/V940 based on data from KEYNOTE-942 which showed that the addition of an mRNA vaccine to adjuvant pembrolizumab improved recurrence-free survival following resection of high-risk melanoma.
Toripalimab Plus Chemotherapy Lengthens PFS in Chinese Metastatic/Recurrent TNBC Population
February 22nd 2023In the phase 3 TORCHLIGHT study, survival advantages were shown with the combination of toripalimab and the chemotherapy agent nab-paclitaxel in patients with recurrent/metastatic triple-negative breast cancer treated in Chinese centers.
FDA Grants Priority Review to BLA of Elranatamab for R/R Multiple Myeloma
February 22nd 2023Results from cohort A of the MagnetisMM–3 trial of erlanatamab for patients with relapsed/refractory multiple myeloma have led the FDA to grant priority review to a biologics license application for the agent in this patient population.
Brexu-cel Generates Durable Responses and Survival Benefits in R/R B-ALL
February 22nd 2023An analysis with longer follow-up of the ZUMA-3 study showed patients with relapsed/refractory B-cell acute lymphoblastic leukemia treated with brexu-cel had a median overall survival of 26 months and a complete response plus CR with incomplete count recovery rate of 71%.
Pano/GemBuMel May Be Safe/Effective for Treatment of High-Risk, R/R Myeloma
February 22nd 2023In an interview with Targeted Oncology, Yago Nieto, MD, PhD, discussed the full data from the phase 2 trial of panobinostat, gemcitabine, busulfan, and melphalan for patients with high-risk, relapsed/refractory myeloma.
Real-World Data Supports Avelumab Use for Locally Advanced, Metastatic Urothelial Carcinoma
February 20th 2023Treatment with avelumab for locally advanced or metastatic urothelial carcinoma showed to be consistent in a real-world with what was previously seen in the phase 3 JAVELIN Bladder 100 trial.
Role of Piflufolastat F 18 Reinforced in Prostate Cancer With Low PSA Levels
February 20th 2023The secondary analysis of the phase 3 CONDOR study showed that given prior positron emission tomography, piflufolastat F 18 demonstrated changes in intended management, reinforcing the agent's clinical utility.