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Arjun V. Balar, MD, highlights the KEYNOTE-057 study findings and provides insight into the role of immunotherapy in bladder cancer.

The FDA has granted P-BCMA-101 with an orphan drug designation for the treatment of patients with relapsed and/or refractory multiple myeloma.









Bladder Cancer

Vofatamab when given as a monotherapy or in combination with docetaxel was well tolerated and had no long-term safety issues in 55 patients with metastatic urothelial cancer who had failed platinum-based chemotherapy, according to the results of a phase II expansion study.

Thomas W. Flaig, MD, discusses the most dramatic change in the treatment landscape for patients with advanced bladder cancer. Over the last several years, 5 checkpoint inhibitors have been approved in this space.

A look back at all the FDA news that happened in the month of April 2019, including several new approvals, a priority review, breakthrough designation, and more.

Arjun V. Balar, MD, discusses key findings from updated data from the interim analysis of KEYNOTE-057, a phase II single-arm trial of pembrolizumab (Keytruda) in Bacillus Calmette-Guérin-unresponsive, high-risk nonmuscle-invasive bladder cancer, which he presented during the the 2019 Genitourinary Cancers Symposium.

The immune checkpoint inhibitor pembrolizumab continued to demonstrate encouraging antitumor activity in an interim analysis of KEYNOTE-057, which involved a subset of 102 patients with nonmuscle-invasive bladder cancer.

Erdafitinib (Balversa) has been granted an accelerated approval by the FDA as a treatment for adult patients with locally advanced or metastatic bladder cancer with an <em>FGFR3</em> or <em>FGFR2</em> alteration that has progressed on platinum-containing chemotherapy, making it the first targeted agent to receive approval for metastatic bladder cancer.

A discussion between regulators and special interest groups has cooled some of the excitement generated by the emergence of chimeric antigen receptor T-cell therapy for treating hematologic cancers.

Before a community oncology practice considers getting involved in clinical trials research, there are many factorsto consider. Perhaps foremost is the fact that cancer clinical trials provide the evidence base for new advances in oncology.

Artificial intelligence has made inroads in many industries—banking, finance, security—but its adoption in healthcare has been lagging and real-world clinical implementation has yet to become a reality. Nonetheless, proponents say it is only a matter of time and pilot programs are starting to yield some practical results.

Frederick L. Locke, MD, discusses how chimeric antigen receptor (CAR) T-cell therapies have evolved over the last 30 years of research in the field of hematologic malignancies.

Peter Grivas, MD, PhD, discusses the next steps necessary for the treatment landscape of advanced urothelial cancer to evolve.

The success of chimeric antigen receptor T-cell therapy observed in hematologic malignancies has not yet translated into the solid tumor setting; however, efforts continue to try to bring this new modality into the treatment paradigm for solid tumors, including pancreatic cancer.

Positive findings have been seen with a novel antibody–drug conjugate in a pivotal trial for patients with advanced or metastatic urothelial cancer who have previously been treated with immunotherapy and chemotherapy, according to an announcement from the co-manufacturers Seattle Genetics and Astellas Pharma.

Thomas W. Flaig, MD, discusses the latest updates to the NCCN guidelines for the treatment of patients with muscle-invasive bladder cancer. In addition, he highlights the latest approvals of checkpoint inhibitors in this patient population.














































