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.

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.

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&nbsp;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&nbsp;metastatic bladder cancer.

A discussion between&nbsp;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.&nbsp;

Artificial intelligence has made inroads in many industries&mdash;banking, finance, security&mdash;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.&nbsp;

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.&nbsp;

Positive findings have been seen with a novel antibody&ndash;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,&nbsp;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.

The healthcare community is still awaiting a response from the Centers for Medicare &amp; Medicaid Services to the opposition of the agency&rsquo;s proposal to substantially revise the Medicare Part D protected drug classes.

Overtreating men 70 years or older with prostate cancer cost Medicare more than $1.2 billion from 2004 to 2007, according to the results of a retrospective study using the Surveillance, Epidemiology, and End Results&ndash;Medicare linked database.

Ongoing research seeks to boost objective response rates in urothelial cancer by developing biomarkers to predict which immune checkpoint inhibitors a patient is most likely to respond to and by testing these in combination with each other and other treatment types to increase both the number and duration of responses.

Scott T. Tagawa, MD,&nbsp;discusses the potential of sacituzumab govitecan in advanced urothelial cancers and reflected on progress made in prostate cancer.

The combination of lenvatinib plus pembrolizumab induced responses in a quarter of patients with urothelial carcinoma, according to the results of a small study presented at the 2019 ASCO-SITC Clinical Immuno-Oncology Symposium. The immunotherapy/targeted therapy combination also demonstrated a manageable toxicity profile.

Bempegaldesleukin, a novel interleukin-2 therapy, showed promising activity when combined with&nbsp;nivolumab in&nbsp;patients with metastatic urothelial carcinoma who were cisplatin ineligible or refused standard therapy, according to&nbsp;preliminary data from the PIVOT-02 study.

According to findings from an open-label, single-arm phase I/II basket study presented during the&nbsp;2019 Genitourinary Cancers Symposium, 14 of 45 patients with relapsed/refractory metastatic urothelial cancer demonstrated an objective response to&nbsp;sacituzumab govitecan, for an objective response rate of 31.1%.

Petros Grivas, MD, PhD,&nbsp;discusses the rapidly evolving locally advanced and metastatic bladder cancer field.