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bladder cancer

FDA Grants Accelerated Approval to Erdafitinib for Metastatic Urothelial Carcinoma

Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to erdafitinib (Balversa) for patients with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 or FGFR2 genetic alterations that has progressed during or following platinum-containing...

bladder cancer

EAU 2019: Early Menopause in Smokers May Be Linked to Increased Risk of Bladder Cancer

New research has shown that experiencing menopause before the age of 45 is associated with a higher risk of bladder cancer; this higher risk was even more notable in smokers. The study, which looked at health outcomes in more than 220,000 patients, was presented by Abufaraj et al at the European...

bladder cancer

2019 GU Cancers Symposium: Adjuvant Sequential Chemotherapy Plus Radiotherapy vs Radiotherapy Alone for Locally Advanced Bladder Cancer

A phase III Egyptian trial presented by Zaghloul et al (Abstract 351) at the 2019 Genitourinary Cancers Symposium focused on the benefit of adjuvant chemotherapy in patients with locally advanced bladder cancer treated with postoperative radiotherapy. Researchers compared postoperative radiotherapy ...

bladder cancer

Bladder-Sparing Treatment Regimens for Muscle-Invasive Bladder Cancer

In a phase II trial (NRG/RTOG 0712) reported in the Journal of Clinical Oncology, Coen et al found that bladder-sparing treatment with twice-daily radiation plus fluorouracil/cisplatin (FCT) or once-daily radiation plus gemcitabine (GD) produced similar distant metastasis-free survival in patients...

breast cancer
gynecologic cancers
lymphoma
pancreatic cancer
gastroesophageal cancer
bladder cancer
symptom management
gastrointestinal cancer

FDA Pipeline: What’s New in Biosimilars, Drug Reviews, Designations, and More

The U.S. Food and Drug Administration (FDA) recently issued the following new approvals and designations: Approval for Pegfilgrastim Biosimilar The FDA recently approved a pegfilgrastim biosimilar, pegfilgrastim-cbqv (Udenyca). The biosimilar has been approved to decrease the incidence...

bladder cancer
immunotherapy

PURE-01 Trial: Neoadjuvant Immunotherapy in Muscle-Invasive Bladder Carcinoma

In the Italian phase II PURE-01 trial reported in the Journal of Clinical Oncology, Necchi et al found that neoadjuvant pembrolizumab (Keytruda) before radical cystectomy in muscle-invasive bladder carcinoma produced complete pathologic response (pT0) in 42% of patients, with pT0 being more common...

bladder cancer

Outcomes With Neoadjuvant Chemotherapy Regimens in Muscle-Invasive Bladder Cancer

In a single-center analysis reported in JAMA Oncology, Peyton et al found that neoadjuvant dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (ddMVAC) produced better outcomes than other standard neoadjuvant regimens in patients undergoing radical cystectomy for muscle-invasive...

bladder cancer
immunotherapy

FDA Updates Prescribing Information for Pembrolizumab and Atezolizumab in Urothelial Carcinoma

On August 16, 2018, the U.S. Food and Drug Administration (FDA) updated the prescribing information for pembrolizumab (Keytruda) and atezolizumab (Tecentriq) to require the use of an FDA-approved companion diagnostic test to determine programmed cell death ligand 1 (PD-L1) levels in tumor tissue...

bladder cancer

VB4-845 Granted Fast Track Designation by FDA for Treatment of Non–Muscle Invasive Bladder Cancer

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to VB4-845 for the treatment of bacillus Calmette-Guérin (BCG)–unresponsive, high-grade, non–muscle invasive bladder cancer. VB4-845 is currently being evaluated in a phase III registration...

colorectal cancer
kidney cancer
hepatobiliary cancer
lung cancer
pancreatic cancer
issues in oncology
bladder cancer

Large Disparities in Cancer Mortality Rates Found Among Different Racial/Ethnic Populations in New York State

According to the American Cancer Society, cancer is the leading cause of death for Hispanics and Asian/Pacific Islanders in the United States. However, their cancer burden is less than that of non-Hispanic whites and especially non-Hispanic blacks, who bear the most disproportionate share of the...

bladder cancer

STAG2 Genetic Test Could Reduce Overtreatment in Some Patients With Bladder Cancer

A new genetic test in bladder cancer could be key to reducing the cost of care while avoiding overtreatment in some patients, according to research published by Waldman et al in Clinical Cancer Research. Deciding whether to treat bladder cancer aggressively can be difficult—predictive...

bladder cancer
immunotherapy

FDA Restricts Use of Pembrolizumab or Atezolizumab to Treat Urothelial Cancer Due to Efficacy Concerns in Some Patients

As of June 20, the U.S. Food and Drug Administration (FDA) has restricted the use of pembrolizumab (Keytruda) and atezolizumab (Tecentriq) for patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing therapy. The restriction results from a...

bladder cancer

2018 ASCO: Erdafitinib Shows Activity in FGFR3-Mutated Urothelial Cancer

In an international phase II trial led by researchers at The University of Texas MD Anderson Cancer Center, treatment with the oral FGFR inhibitor erdafitinib was well tolerated and achieved a robust response for patients with metastatic urothelial cancers harboring mutations in the FGFR3...

bladder cancer
immunotherapy

FDA Identifies Efficacy Issue in Clinical Trials of Pembrolizumab or Atezolizumab as Monotherapy in Urothelial Cancer With Low Expression of PD-L1

On May 18, the U.S. Food and Drug Administration (FDA) alerted health-care professionals, oncology clinical investigators, and the public about decreased survival associated with the use of pembrolizumab (Keytruda) or atezolizumab (Tecentriq) as monotherapy in clinical trials to treat patients with ...

bladder cancer

Dose-Dense Neoadjuvant Chemotherapy in Muscle-Invasive Bladder Cancer

In a phase II trial reported in the Journal of Clinical Oncology, Iyer et al found that dose-dense neoadjuvant gemcitabine plus cisplatin produced a high response rate and was generally well tolerated in patients with planned radical cystectomy for muscle-invasive bladder cancer. Study Details In ...

bladder cancer

Intravesical Instillation of Gemcitabine Postsurgery May Aid in Preventing Bladder Cancer Recurrence

Flushing the bladder with a common chemotherapy drug immediately after surgery significantly reduces the chances of bladder cancer returning, according to a study by Messing et al published in JAMA and led by SWOG. First author Edward M. Messing, MD, is Professor of Urology and...

bladder cancer

Results From Phase III RANGE Study of Ramucirumab in Advanced or Metastatic Urothelial Cancer

Eli Lilly and Company recently announced additional results from its global, randomized, double-blind, placebo-controlled phase III RANGE trial evaluating ramucirumab (Cyramza) in combination with docetaxel in patients with locally advanced or unresectable or metastatic urothelial carcinoma whose...

bladder cancer
immunotherapy

Health-Related Quality-of-Life Analysis of Anti–PD-1 Therapy vs Chemotherapy in Advanced Urothelial Cancer

As reported by Vaughn et al in the Journal of Clinical Oncology, a health-related quality-of-life analysis from the phase III KEYNOTE-045 trial in previously treated advanced urothelial cancer showed that patients treated with the anti–programmed cell death protein 1 immunotherapy...

bladder cancer

FDA Grants Fast Track Designation for TAR-200 in Muscle-Invasive Bladder Cancer

On April 3, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for TAR-200, a gemcitabine-releasing intravesical system (GemRIS), for the treatment of patients with organ-confined or locally advanced muscle-invasive bladder cancer who are unfit for curative-intent therapy....

bladder cancer

FDA Grants Breakthrough Therapy Designation to Enfortumab Vedotin for Locally Advanced or Metastatic Urothelial Cancer

On March 26, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to enfortumab vedotin, an antibody-drug conjugate (ADC), for patients with locally advanced or metastatic urothelial cancer who were previously treated with checkpoint inhibitors. Breakthrough Therapy ...

kidney cancer
prostate cancer
bladder cancer

EAU 2018: Survey Shows Greater Suicide Rate in Patients With Urologic Cancers

A major UK survey has shown that patients with urologic cancer—such as prostate, bladder, or kidney cancer—are five times more likely to commit suicide than people without cancer. The analysis also shows that patients with cancer generally are around three times more likely to commit...

bladder cancer
immunotherapy

Alterations in DNA Damage Response and Repair Genes and Response to PD-1/PD-L1 Inhibitors in Advanced Urothelial Cancer

In a study reported in the Journal of Clinical Oncology, Teo et al found that alterations in DNA damage response and repair (DDR) genes, particularly known or likely deleterious alterations, were associated with response to programmed cell death protein 1 (PD-1)/programmed cell death ligand 1...

bladder cancer

FDA Grants Breakthrough Therapy Designation to Erdafitinib for the Treatment of Metastatic Urothelial Cancer

On March 15, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to erdafitinib for the treatment of urothelial cancer. Urothelial cancer, most frequently in the bladder, is the sixth most common type of cancer in the United States. A Breakthrough Therapy ...

bladder cancer
immunotherapy

Long-Term Outcomes With PD-L1 Inhibition in Metastatic Urothelial Cancer

As reported by Petrylak et al in JAMA Oncology, long-term follow-up of patients in a phase I study expansion cohort indicated enduring clinical benefit and maintained tolerability of atezolizumab (Tecentriq) in patients with metastatic urothelial carcinoma.  Study Details The study involved...

bladder cancer
immunotherapy

2018 GU CANCERS SYMPOSIUM: New Model Predicts Survival for People With Bladder Cancer Receiving Immunotherapy

Researchers have developed a model to predict overall survival for people with advanced urothelial cancers treated with the immune checkpoint inhibitor atezolizumab (Tecentriq). The model, which is based on six clinical factors, may help inform treatment decisions for use of atezolizumab in these...

bladder cancer
immunotherapy

IMvigor211 Trial: Atezolizumab vs Chemotherapy in Platinum-Treated Advanced Urothelial Carcinoma

The phase III IMvigor211 trial showed no survival benefit for atezolizumab (Tecentriq) vs physician's choice of chemotherapy in platinum-treated locally advanced or metastatic urothelial carcinoma with programmed death-ligand 1 (PD-L1) expression ≥ 5%. Findings were reported in The Lancet by...

bladder cancer

First-Line Immunotherapy for Cisplatin-Ineligible Patients With Advanced Urothelial Cancer

As reported in The Lancet Oncology by Balar et al, first-line pembrolizumab (Keytruda) produced durable responses in cisplatin-ineligible patients with locally advanced and unresectable or metastatic urothelial cancer in the phase II KEYNOTE-052 trial. The trial supported the accelerated approval...

bladder cancer

ESMO 2017: KEYNOTE-045: Updated Results Support Pembrolizumab as Second-Line Treatment in Advanced Urothelial Cancer

Mature results from the KEYNOTE-045 trial presented at the European Society for Medical Oncology (ESMO) 2017 Congress in Madrid (Abstract LBA37_PR) confirmed significantly longer survival in patients with advanced urothelial cancer who received the checkpoint inhibitor pembrolizumab after initial...

bladder cancer

Adjuvant Chemotherapy vs Observation After Neoadjuvant Therapy and Radical Cystectomy for Bladder Cancer

In an analysis reported in JAMA Oncology, Seisen et al found that adjuvant chemotherapy was associated with a survival benefit vs observation in patients with adverse prognostic features after neoadjuvant therapy and radical cystectomy for urothelial carcinoma of the bladder. Study Details The...

bladder cancer

Recombinant Adenovirus Interferon-α With Syn3 in BCG-Refractory or Relapsed Non–Muscle Invasive Bladder Cancer

A phase II study has shown activity of recombinant adenovirus interferon-α with Syn3 (rAd-IFNα/Syn3), a replication-deficient recombinant adenovirus gene transfer vector, in patients with high-grade bacillus Calmette-Guerin (BCG)-refractory or -relapsed non–muscle invasive bladder ...

bladder cancer

Durvalumab in Locally Advanced or Metastatic Urothelial Carcinoma

Updated results of a phase I/II study of durvalumab (Imfinzi) in locally advanced or metastatic urothelial carcinoma were reported by Powles et al in JAMA Oncology. Data from the ongoing study supported the recent approval of durvalumab as second-line treatment in this setting on the basis of...

bladder cancer

Treatment of Nonmetastatic Muscle-Invasive Bladder Cancer: AUA/ASCO/ASTRO/SUO Guideline

As reported in the Journal of Oncology Practice by Chang et al, for the first time for any type of malignancy, the American Urological Association (AUA), ASCO, American Society for Radiation Oncology (ASTRO), and Society of Urologic Oncology (SUO) have formulated an evidence-based guideline on...

bladder cancer

European Commission Approves Nivolumab for Previously Treated, Locally Advanced, Unresectable or Metastatic Urothelial Cancer

On June 2, the European Commission (EC) approved nivolumab (Opdivo) for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-containing therapy. This makes nivolumab the first immuno-oncology agent approved in the European Union ...

bladder cancer

AUA 2017: Phase III Study of Blue Light Cystoscopy With Optical Imaging Agent in Bladder Cancer

New phase III study results of blue light flexible cystoscopy (BLFC) with an optical imaging agent (Hexvix/Cysview) were presented by Daneshmand et al during a late-breaking plenary session at the 2017 American Urological Association (AUA) Annual Meeting (Abstract PPTLBA-02). Major Findings The...

bladder cancer

FDA Approves Pembrolizumab for Advanced or Metastatic Urothelial Carcinoma

Today, the U.S. Food and Drug Administration (FDA) granted regular approval to pembrolizumab (Keytruda) for patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or...

bladder cancer

AUA 2017: Studies Examine Bladder Cancer Risk and Mortality in E-Cigarette and Traditional Smokers

Data presented at the 2017 Annual Scientific Meeting of the American Urological Association (AUA) showed harmful links between the use of e-cigarettes and bladder cancer risk, and associated the smoking of traditional cigarettes to a higher risk of mortality among patients with bladder cancer. Even ...

bladder cancer

FDA Grants Accelerated Approval to Avelumab for Urothelial Carcinoma

Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to avelumab (Bavencio) for patients with locally advanced or metastatic urothelial carcinoma whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant...

bladder cancer

FDA Approves Durvalumab in Locally Advanced or Metastatic Urothelial Carcinoma

Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to durvalumab (Imfinzi) for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or who have disease...

bladder cancer

Second-Line Pazopanib vs Weekly Paclitaxel in Relapsed or Progressive Urothelial Cancer

A UK phase II trial comparing pazopanib (Votrient) with paclitaxel after failure of platinum-based therapy in patients with locally advanced or metastatic urothelial carcinoma was stopped early due to futility. These results were reported by Jones et al in the Journal of Clinical Oncology. Two...

bladder cancer

FDA Grants Atezolizumab Accelerated Approval as Initial Treatment for Some Advanced Bladder Cancers

On April 17, the U.S. Food and Drug Administration (FDA) granted accelerated approval to atezolizumab (Tecentriq) for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin chemotherapy. Atezolizumab was previously approved for people...

lung cancer
bladder cancer

Study Identifies How Cancer Cells May Develop Resistance to FGFR Inhibitors

A new study by researchers at The Ohio State University Comprehensive Cancer Center–Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC– James) has identified a mechanism by which cancer cells develop resistance to a class of drugs called fibroblast growth...

bladder cancer

Pembrolizumab vs Chemotherapy in Second-Line Treatment of Advanced Urothelial Carcinoma

In a phase III KEYNOTE-045 trial reported in The New England Journal of Medicine, Bellmunt et al found that pembrolizumab (Keytruda) significantly improved overall survival vs investigator choice of chemotherapy as second-line treatment in patients with advanced urothelial cancer whose disease...

bladder cancer

2017 GU Cancers Symposium: Updated Efficacy and Tolerability of Durvalumab in Locally Advanced or Metastatic Urothelial Carcinoma

At the 2017 Genitourinary Cancers Symposium, Powles et al presented updated efficacy and safety data for durvalumab in patients with locally advanced or metastatic urothelial cancer (Abstract 286). Updated results from the phase I/II trial showed an objective response rate of 20.4% in all...

bladder cancer

Nivolumab in Metastatic Urothelial Carcinoma After Platinum Therapy

As reported in The Lancet Oncology by Sharma et al, the phase II CheckMate 275 trial has shown nivolumab (Opdivo) to produce durable responses in patients with metastatic urothelial cancer who had received at least one prior platinum-based regimen. The study supported the recent accelerated...

bladder cancer

FDA Accepts Two sBLAs for Pembrolizumab in Locally Advanced or Metastatic Urothelial Cancer

On February 3, the U.S. Food and Drug Administration (FDA) accepted for review two supplemental Biologics License Applications (sBLAs) for pembrolizumab (Keytruda) in patients with locally advanced or metastatic urothelial cancer. Specifically, the application for first-line use was accepted and...

bladder cancer

FDA Approves Nivolumab in Locally Advanced or Metastatic Bladder Cancer

On February 2, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to nivolumab (Opdivo) for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have...

bladder cancer

Pembrolizumab Studied in Locally Advanced or Metastatic Urothelial Cancer

As reported by Plimack et al in The Lancet Oncology, pembrolizumab (Keytruda) has shown activity in patients in the locally advanced or metastatic urothelial carcinoma cohort included in the phase Ib KEYNOTE-012 trial. Study Details In the study, 33 patients with locally advanced or metastatic...

bladder cancer

FDA Accepts sBLA and Grants Priority Review for Atezolizumab in Locally Advanced or Metastatic Urothelial Carcinoma

On January 9, the U.S. Food and Drug Administration (FDA) accepted the supplemental Biologics License Application (sBLA) and granted Priority Review for atezolizumab (Tecentriq) in the treatment of patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin...

bladder cancer

Survival Benefit Reported With Adjuvant Chemotherapy After Nephroureterectomy for Urothelial Carcinoma

In a National Cancer Database analysis reported in the Journal of Clinical Oncology, Seisen et al found that adjuvant chemotherapy after radical nephroureterectomy was associated with an overall survival benefit in patients with locally advanced or regional lymph node–positive upper tract...

bladder cancer

Atezolizumab Shows Activity in First-Line Treatment of Cisplatin-Ineligible Patients With Advanced Urothelial Carcinoma

In a phase II trial reported in The Lancet, Balar et al found that first-line atezolizumab (Tecentriq) produced durable responses in cisplatin-ineligible patients with locally advanced or metastatic urothelial carcinoma. In the study, 119 patients from 47 sites in North America and Europe who were ...

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