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New Drug For Bladder Cancer

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Transurethral Resection Of The Bladder Cancer Tumor

New drug developed at UT-Health SA may prevent bladder cancer from returning

This is when the tumor is removed from the urinary tract through the urethra using an electrical force. Transurethral resection is an endoscopic or scope procedure that does not involve making an incision in the body.

Drug therapy after TUR is commonly prescribed for patients with large, multiple or high-grade tumors.

Cystoscopy With Cautery Destruction Of The Bladder Tumor

Cystoscopy is an outpatient procedure during which a thin, lighted tube with a camera is passed through the urethra into the bladder, allowing your doctor to see the inside of the bladder.

Most modern cystoscopes are also equipped with channels that permit small instruments to be passed into the bladder. During a cystoscopy, your doctor may use these instruments to remove tissue, stop bleeding with a special electrical device called an electrocautery or even perform laser treatment. If the bladder cancer tumor is small enough, this cautery may be used to remove the cancer.

Combination Of Fgfr Inhibitors With Immunotherapy

Erdafitinib, as the first TKI approved in UC therapy, has been demonstrated to be beneficial in clinical trials. Similar to other targeted drugs, toxicity and drug responses become concerns. Research has suggested that the presence of an antitumor T-cell response is fundamental for the activity of immunotherapy . Recently, Sweis et al. showed that UC can be divided into T-cell-inflamed and non-T-cell-inflamed subtypes. The latter phenotype correlated with a resistance to ICIs, but was also linked to FGFR3 mutation, providing a rationale for combining FGFR inhibitors and anti-PD-1/PD-L1 . Preliminary data in the FIERCE-22 study showed that the ORR was 36% in the overall population, and a response was observed in both wild type and mutated FGFR3 patients receiving vofatamab and pembrolizumab . Powles et al. conducted a phase I study enrolled with platinum-resistant and ICI naïve patients with A/M UC harboring FGFR mutations . However, the results showed that AZD4547 plus durvalumab increased response modestly compared to AZD4547 alone , suggesting that the tumor mutations burden might contribute rather small differences to ICI response. A phaseIb/II study of rogaratinib combined with atezolizumab in patients with untreated FGFR-positive UC is currently in progress . Likewise, the safety and efficacy of erdafitinib plus JNJ-63723283 are investigated by a phase Ib/II study in advanced UC patients with FGFR gene alterations.

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New Treatment Option For Advanced Urothelial Cancer Patients Shows Promise In A Phase 2 Clinical Trial

Bladder cancer medical concept. Credit: Shutterstock

A new treatment for advanced urothelial cancer was effective with tolerable side effects in an international, multi-center phase 2 clinical trial led by investigators at Weill Cornell Medicine and NewYork-Presbyterian.

The trial results prompted a U.S. Food and Drug Administration accelerated approval of the treatment on April 13, giving patients with this very aggressive type of cancer a new therapeutic option.

In the study, published in the Aug. 1 print issue of the Journal of Clinical Oncology and online April 30, the researchers gave the treatment, sacituzumab govitecan , previously known as IMMU-132 and now by the trade name Trodelvy, to 113 patients with advanced urothelial carcinoma, the most common type of bladder cancer. The trial population had progressed despite treatment with platinum-based chemotherapy and immune-boosting checkpoint inhibitors, and overall had a median of 3 prior lines of therapy. Treatment with SG was followed by sustained reductions in tumor size for 31 patients , including complete tumor disappearance in six patients. The most common severe side effects included very low white blood cell count in 34 percent and severe diarrhea in 9 percent, which were managed with dose adjustment and best supportive care.

In the meantime, thanks to our study, this treatment will continue to be available to at least some of our patients with bladder cancer, said Dr. Tagawa.

In Review: New Cancer Drug Approvals

FDA OKs immune

Chemotherapy is one of the most powerful tools we have to treat cancer, and research continues to find new chemotherapy drugs as well as new uses for existing ones. At the same time, newer types of drugs are being developed that work in different ways to attack cancer cells. These types of treatments include targeted therapy, which aims to more precisely identify and go after cancer cells while doing less damage to normal cells, and immunotherapy, which uses the bodys own immune system to help find and destroy cancer.

Before any new drug can be sold in the United States, it goes through an approval process. The FDA evaluates evidence from testing to decide whether the drugs benefits outweigh any known risks. The FDA also provides doctors and patients with information about how to use the new drug safely.

In 2019, the FDA approved several new drug treatments for different cancer types that American Cancer Society editors believe will make a significant difference.

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How Could This Change Treatment For Bladder Cancer Patients

Its a major advance. The standard of care for these patients has been observation because no chemotherapy or immunotherapy has shown a benefit. A few years ago, another immunotherapy drug, atezolizumab, was tested in an international trial on the same kind of patients and had disappointing results. So, the absence of good treatment options has been frustrating for both patients and doctors to know someone has high-risk disease and yet not be able to offer them a treatment to reduce recurrence. Now for the first time, a new immunotherapy accomplishes exactly that.

Its too early to know whether nivolumab will also allow these patients to live longer. This was a double-blinded study, meaning neither doctor nor patient knows who received the drug, and it will take a while longer to learn about the impact on survival. But its important not to be focused only on survival and overlook that patients truly benefit by preventing or delaying the cancers return. This type of urothelial cancer is an aggressive disease no matter where it starts. When it recurs, patients suffer a serious drop in quality of life, and it impairs their functional ability. So, disease-free survival is very important in its own right. Its also important to note the vast majority of patients taking the drug still had a high quality of life without serious side effects, which were monitored very closely during the trial.

Combination Of Pi3k/akt/mtor Inhibitors With Immunotherapy Or Chemotherapy

The PI3K/AKT/mammalian target of rapamycin pathway is an important signal pathway closely related to protein synthesis, cell growth, survival and tumorigenesis . The deregulation of this signaling pathway is present in 42% of UC, including mutations, copy number alterations, or RNA expression changes . Despite the frequent deregulation, clinical trials using PI3K/mTOR inhibitors have not shown prominent success. The PIK3CA gene is an oncogene that implicates the overactivation of the PI3K/AKT/mTOR pathway. Recurrent somatic mutations of PIK3CA increase the activity of PI3Ks and the loss of phosphatase and tension homolog also can result in the overactivation of the PI3K/AKT/mTOR pathway .

A study in human glioma suggested that the loss of PTEN and the consequent upregulation of the PI3K-AKT pathway increased the expression of PD-L1 post-transcriptionally, thus promoting immune resistance . Additionally, other reports validated this resistance in melanoma, prostate and breast cancers, making the inhibition of PI3K-AKT pathway a potential strategy to overcome immunotherapy-resistance .

Chemotherapy drugs kill tumor cells primarily through the induction of apoptosis. The activation of PI3K/AKT/mTOR pathway in tumor cells reduces the pro-apoptotic effect and the cytotoxic effect of chemotherapy drugs, leading to resistance . Therefore, inhibition of this signaling pathway may enhance the sensitivity of chemotherapy drugs.

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Treating Bladder Cancer: Engineering Of Current And Next Generation Antibody

  • 1Institute for Organic Chemistry and Biochemistry, Technical University of Darmstadt, Darmstadt, Germany
  • 2Ferring Darmstadt Laboratory, Biologics Technology and Development, Darmstadt, Germany
  • 3Ferring Pharmaceuticals, International PharmaScience Center, Copenhagen, Denmark
  • 4Global Pharmaceutical Research and Development, Ferring International Center S.A., Saint-Prex, Switzerland

Urine Tests To Look For Bladder Cancer

Schumer warns about bladder cancer drug shortage locally

Several newer tests look for substances in urine that might help show if a person has bladder cancer. These tests are mostly used to help diagnose bladder cancer or to look for cancer that has come back in people who have already been treated. Researchers are now looking to see if these tests might be helpful even earlier, to screen for bladder cancer in people who don’t have symptoms.

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Current And Future Trends In The Bladder Cancer Treatment Paradigm

Matthew Galsky, MD, discusses the future of bladder cancer research and the impact of new treatments such as immune checkpoint inhibitors and antibody-drug conjugates.

Matthew Galsky, MD, professor of medicine and director of genitourinary medical oncology at Mount Sinai, and codirector of the Center of Excellence for Bladder Cancer and associate director for translational research at the Tisch Cancer Institute, discusses the future of bladder cancer research and the introduction of new treatments.

According to Galsky, chemotherapy used to be the only treatment option for urothelial cancer, and there were few chemotherapies available such as cisplatin and carboplatin. More recently, new drugs have been approved for treatment, including immune checkpoint inhibitors, antibody-drug conjugates, and combination therapies.

Single-arm phase 1 studies led to the approval of immune checkpoint inhibitors in urothelial carcinoma, including nivolumab and pembrolizumab , which were both approved by the FDA in 2017 for locally advanced and metastatic disease. These provide new options for patients who cannot receive platinum-based chemotherapy or have platinum-resistant disease. Enfortumab vedotin , an antibody-drug conjugate, received FDA approval in 2021 for patients who progressed after receiving platinum-based chemotherapy and an immune checkpoint inhibitor.


Combination Of Ido1 With Immunotherapy

Indoleamine 2,3-dioxygenase 1 enzyme is involved in the catabolism of the essential amino acid tryptophan and plays an important role in immune evasion and tumor growth through production of kynurenine. The IDO1 enzyme is activated in many human cancers including NMIBC . Recent data indicate that IDO1 gene expression characterizes a poorly differentiated, more aggressive NMIBC, with IDO1 gene expression in tumor tissues directly correlating with tumor size =0.24, p=0.04) and stage . Moreover, there was a trend toward longer OS in patients with tumors that did not express IDO1. IDO inhibitors such as BMS-986205, epacadostat, indoximod, navoximod, and HTl-1090 are in various stages of clinical development in several cancers. There is evidence supporting an interrelationship between the PD-1/PD-L1 and IDO1 axes, with IDO functional activity linked with increased PD-L1 positive cytotoxic T-cells and increased CTLA4 expression by regulatory T cells . Therefore, it has been proposed that parallel inhibition of these pathways may lead to a more effective activation of T cell mediated antitumor immune response.

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Intermediate Risk Early Bladder Cancer

People with intermediate-risk non-muscle-invasive bladder cancer should be offered a course of at least 6 doses of chemotherapy. The liquid is placed directly into your bladder, using a catheter, and kept there for around an hour before being drained away.

You should be offered follow-up appointments at 3, 9 and 18 months, then once every year. At these appointments, your bladder will be checked using a cystoscopy. If your cancer returns within 5 years, you’ll be referred back to a specialist urology team.

Some of the chemotherapy medicine may be left in your urine after treatment, which could severely irritate your skin.

It helps if you sit down to urinate and that you’re careful not to splash yourself or the toilet seat. Always wash the skin around your genitals with soap and water afterwards.

If you’re sexually active, it’s important to use a barrier method of contraception, such as a condom. This is because the medicines may be present in your semen or vaginal fluids, which can cause irritation.

You also shouldn’t try to get pregnant or father a child while having chemotherapy for bladder cancer, as the medicines can increase the risk of having a child with birth defects.

Bladder Cancer Gets New Treatment New Fda

Advanced Bladder Cancer Successfully Treated In Phase I ...

Written byMohan GarikiparithiPublished onMay 20, 2016

The FDA has just approved a new bladder cancer drug known as Tecentriq , which is intended to treat the most common type of bladder cancer. This is the first drug in its class to be approved to treat bladder cancer. Dr. Richard Pazdur, director of the office of hematology and oncology products in the FDAs Center for Drug Evaluation and Research, said in a news release, Tecentriq provides these patients with a new therapy targeting the PD-L1 pathway. Products that block PD-1/PD-L1 interactions are part of an evolving story about the relationship between the bodys immune system and its interaction with cancer cells.

The drug was approved for use in patients with locally advanced or metastatic urothelial carcinoma whose disease has worsened during or following platinum-containing chemotherapy, or within 12 months of receiving platinum-containing chemotherapy, either before or after surgery.The approval comes following a clinical trial, which was completed on 310 patients with locally advanced or metastatic urothelial carcinoma. Nearly 15 percent of patients saw shrinkage in their tumor lasting for at least two months and up to 14 months.

Tumor response occurred in 26 percent of patients who were positive for PD-L1 expression, compared with 9.5 percent of those who were negative for PD-L1 expression.

Also, read Bel Marra Healths article on 3 signs you may have a bladder problem.

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English May Miss Out On New Drug For Bladder Cancer

A drug that can give terminal bladder cancer patients months more good quality life is being prescribed on the NHS in Scotland but not England.

Experts said they were gobsmacked when trial results last year showed that the medication, called avelumab, boosted survival in patients deemed incurable by an average of eight months.

Some of those on the trial have been stable for three years or more the average life expectancy for advanced bladder cancer patients is typically less than one and a half years.

Last week the Scottish Medicines Consortium gave the green light for NHS Scotland to prescribe avelumab, which costs £20,000 a year per patient and has been hailed as the first advance in treating late-stage bladder cancer for two decades.

But Englands watchdog, the National Institute for Health and Care Excellence , has refused to approve the treatment for NHS England.

In May, the body issued draft guidance saying it would not recommend avelumab also known under brand name Bavencio for advanced bladder cancer patients as it wasnt deemed cost effective.

Professor Alison Birtle, a cancer specialist at Lancashire Teaching Hospitals, called the situation heartbreaking.

Combination Of Parp Inhibitors With Immunotherapy

Epigenetics is defined as a heritable modification to DNA without alteration in the nucleotide sequence, resulting in altered gene transcription and chromatin structure. Epigenetic modifications include DNA methylation and post-translational histone modifications involving methylation or acetylation are common in bladder tumors. Growing evidence showed that epigenetic drugs, such as DNA methyltransferase inhibitors can upregulate immune signaling through demethylation of endogenous retroviruses and cancer testis antigens. It provides a strong rationale for the combination of epigenetic drugs with ICIs . Interestingly, RRx-001, not only a new DNA damage inducer, but also an epigenetic and immunomodulatory drug, has been recently investigated as single chemotherapeutic agent to re-sensitize tumor to prior therapy . The low toxicity profile of RRx-001 differentiates this agent from conventional anticancer drugs, such as chemotherapeutics, and epigenetic agents . Indeed, RRx-001 is able to trigger DNA damage response in urothelial bladder cancer cells, reducing the DNA methyltransferase1 levels and increasing the transcriptional levels of the interferon type III and the interferon stimulated genes . Thus, it enhances the sensitivity to ICIs. Criscuolo D et al. investigated the effects of combining three classes of drugs together with epigenetic agents and immune-checkpoint inhibitors in bladder cancer for the purpose of reducing toxicity and doses of monotherapy alone .

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If Treatment Does Not Work

Full recovery from bladder cancer is not always possible. If the cancer cannot be cured or controlled, the disease may be called advanced or metastatic.

This diagnosis is stressful, and for many people, advanced cancer is difficult to discuss. However, it is important to have open and honest conversations with your health care team to express your feelings, preferences, and concerns. The health care team has special skills, experience, expertise, and knowledge to support patients and their families, and is there to help. Making sure a person is physically comfortable, free from pain, and emotionally supported is extremely important.

Patients who have advanced cancer and who are expected to live less than 6 months may want to consider hospice care. Hospice care is a specific type of palliative care designed to provide the best possible quality of life for people who are near the end of life. You and your family are encouraged to talk with the health care team about hospice care options, which include hospice care at home, a special hospice center, or other health care locations. Nursing care and special equipment can make staying at home a workable option for many families. Learn more about advanced cancer care planning.

After the death of a loved one, many people need support to help them cope with the loss. Learn more about grief and loss.

Fda Approves New Drug To Treat Bladder Cancer

FDA approves new bladder cancer drug | Dr. Daniel Petrylak

Tecentriq boosted survival in small trial

HealthDay Reporter

THURSDAY, May 19, 2016 — A new drug to treat bladder cancer was approved by the U.S. Food and Drug Administration on Wednesday.

Tecentriq treats the most common type of bladder cancer, called urothelial carcinoma. It’s the first in its class of drugs, called PD-1/PD-L1 inhibitors, approved to treat this type of cancer.

“Tecentriq provides these patients with a new therapy targeting the PD-L1 pathway,” Dr. Richard Pazdur, director of the office of hematology and oncology products in the FDA’s Center for Drug Evaluation and Research, said in an agency news release.

“Products that block PD-1/PD-L1 interactions are part of an evolving story about the relationship between the body’s immune system and its interaction with cancer cells,” he added.

The FDA approved Tecentriq for treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease has worsened during or following platinum-containing chemotherapy, or within 12 months of receiving platinum-containing chemotherapy, either before or after surgery.

Urothelial carcinoma occurs in the urinary tract system, involving the bladder and related organs. An estimated 76,960 new cases of bladder cancer and 16,390 deaths from the disease will occur in the United States in 2016, according to the U.S. National Cancer Institute.

Tecentriq is made by San Francisco-based Genentech.

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