mCRPC

Gilead To Discontinue Phase III ENHANCE Study of Magrolimab Plus Azacitidine in Higher-Risk MDS Gilead Sciences, Inc. reported that the Phase III ENHANCE study in higher-risk myelodysplastic syndromes (MDS) has been halted due to futility based on a planned analysis. The safety data in this trial are consistent ...

Janssen Marks First Approval Worldwide for AKEEGA® (Niraparib and Abiraterone Acetate Dual Action Tablet) The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the European Commission (EC) had granted marketing authorization for AKEEGA® (niraparib and abiraterone acetate [AA]), in the form...

The ASCO Genitourinary (GU) Cancers Symposium, which ended on February 18, 2023, was a three-day scientific and educational meeting designed to provide attendees with in-depth, multidisciplinary analysis of the timely topics in the study, diagnosis, and treatment of GU malignancies. DelveInsight has compiled the sy...

Sanofi’s Rare Disease Drug Xenpozyme Wins World’s First Approval in Japan Sanofi’s Xenpozyme, also known as olipudase alfa, the world's first therapy for the rare disease Niemann-Pick type A/B and B, has been approved for the treatment of children and adults with non-CNS manifestations of Acid Sphingomyelinase D...

Major Key player Arvinas announced completed Phase I and interim Phase II ARDENT data for ARV-110 degrader targeting the androgen receptor (AR). According to the results, Arvinas mentioned that at the data cut-off date, December 20, 2021, the PSA50 response rate was 46% in 28 patients with AR T878X/H875Y tumor muta...

Preliminary findings of Phase I/II dose-expansion study of DS-7300 (a B7-H3 antibody-drug conjugate) in mCRPC patients backed B7-H3 as a potential new target in treatment-resistant prostate cancers (Abstract #87) Immune-checkpoint inhibitors (ICI) have resulted in significant therapeutic advancements in a wide r...

The innovation in the oncology drug pipeline has resulted in a record number of FDA and EU approvals in recent years, as investigators and sponsors seek new and targeted treatments for individuals diagnosed with different types of cancers each year. In 2022, regulators will continue to evaluate new oncology therapi...

FDA approves IND application of Accutar for a prostate cancer treatment trial The US Food and Drug Administration (FDA) has granted Accutar Biotechnology’s Investigational New Drug (IND) application for Phase I clinical trial of AC0176 for treating metastatic castration-resistant prostate cancer (mCRPC). An i...

Biogen-Eisai's potential Aduhelm sequel drug secured speedy review by FDA Biogen and Eisai’s Alzheimer’s disease treatment-in-waiting, lecanemab, has been secured a fast-track tag by the FDA, setting up a potentially swift path through the regulatory process. The drug is the next in line behind the pair’s app...