Monday, January 30, 2023

New Bladder Cancer Drug Approved

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Fda Approves First Targeted Therapy For Bladder Cancer

FDA approves new bladder cancer drug | Dr. Daniel Petrylak

The US Food and Drug Administration has approved Balversa as the first targeted therapy for bladder cancer. The drug is for adults with advanced bladder cancer with a mutation in the FGFR3 or FGFR2 gene, and that has gotten worse after treatment with chemotherapy. The FDA also approved a test to look for these gene mutations.

FGFRs are proteins on cells that help them grow and divide. Some people with bladder cancer have changes in the genes that tell the cells to make FGFRs, which can help the cancer cells grow. Balversa works by targeting cells with these genetic changes.

The FDA based its approval on a clinical trial of 87 people with advanced bladder cancer that had FGFR3 or FGFR2 mutations, and that got worse after chemotherapy. The overall response rate the proportion of people whose tumors shrank during the trial was 32.2%, or about . Most of them had a partial response, which means the cancer shrank but didnt go away completely. The improvements lasted an average of 5 ½ months. Two people had a complete response, which means their cancer could no longer be detected after the treatment.

The most common side effects of Balversa were increased phosphate levels , low sodium levels, mouth sores, tiredness, kidney or liver problems, diarrhea, dry mouth, nail problems, decreased appetite, taste changes, low red blood cell counts, dry skin, dry eyes, and hair loss.

Pembrolizumab Immunotherapeutic Bladder Cancer First Line Treatment

On January 8, 2020, the Food and Drug Administration approved Pembrolizumab for the treatment of patients with Bacillus Calmette-Guerin -unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Pembrolizumab is a FDA approved drug used to treat bladder cancer, head and neck cancer, Hodgkin lymphoma, lung cancer, and melanoma.

According to the FDA, efficacy was investigated in KEYNOTE-057 (NCT, a multicenter, single-arm trial that enrolled 148 patients with high-risk NMIBC, 96 of whom had BCG-unresponsive CIS with or without papillary tumors. Patients received pembrolizumab 200 mg every 3 weeks until unacceptable toxicity, persistent or recurrent high-risk NMIBC or progressive disease, or up to 24 months of therapy without disease progression.

Patients with bladder cancer now have more treatment options available. Read the full FDA Pembrolizumab approval announcement.

Urine Tests To Look For Bladder Cancer

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 dont have symptoms.

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A Groundbreaking Bladder Cancer Treatment With Many Firsts

This was groundbreaking for us on many levelsthis was the first Janssen Oncology compound developed from discovery all the way to approval our first drug using pharmacodynamically guided treatment dosing, which means a patients dose is adjusted based on their phosphate levels and our first drug developed with a companion diagnostic, Patel says.

Physical Emotional And Social Effects Of Cancer

Pfizer, Merck KGaA

Cancer and its treatment cause physical symptoms and side effects, as well as emotional, social, and financial effects. Managing all of these effects is called palliative care or supportive care. It is an important part of your care that is included along with treatments intended to slow, stop, or eliminate the cancer.

Palliative care focuses on improving how you feel feels during treatment by managing symptoms and supporting patients and their families with other, non-medical needs. Any person, regardless of age or type and stage of cancer, may receive this type of care. And it often works best when it is started right after an advanced cancer diagnosis. People who receive palliative care along with treatment for the cancer often have less severe symptoms, better quality of life, report that they are more satisfied with treatment, and they may live longer.

Palliative treatments vary widely and often include medication, nutritional changes, relaxation techniques, emotional and spiritual support, and other therapies. You may also receive palliative treatments similar to those meant to get rid of the cancer, such as chemotherapy, surgery, or radiation therapy.

Before treatment begins, talk with your doctor about the goals of each treatment in the treatment plan. You should also talk about the possible side effects of the specific treatment plan and palliative care options.

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Fda Approves Trodelvy For Advanced Bladder Cancer

The antibody-drug conjugate shrank tumors in 28% of people with locally advanced or metastatic urothelial cancer.

On April 13, the Food and Drug Administration granted accelerated approval of Trodelvy an antibody-drug conjugate that delivers potent chemotherapy to tumorsfor people with previously treated advanced urothelial cancer. This malignancy, originating in cells lining the urinary tract, is the most common type of bladder cancer.

The medication is indicated for adults with locally advanced or metastatic urothelial cancer who previously received platinum-containing chemotherapy and either PD-1 or PD-L1 checkpoint inhibitor immunotherapy.

Trodelvy was developed by Immunomedics, which was acquired by Gilead Sciences last fall. It consists of a monoclonal antibody targeting Trop-2, a protein commonly found on urothelial tumors, which carries an active form of the chemotherapy drug irinotecan.

At last years European Society for Medical Oncologys ESMO Virtual Congress, Yohann Loriot, MD, PhD, of Institut de Cancèrologie Gustave Roussy near Paris, presented findings from Cohort 1, which included 113 people whose cancer had progressed despite platinum-based chemotherapy and checkpoint inhibitors.

Drugs that receive accelerated approval based on response rates in early studies are expected to undergo further testing in larger randomized trials to confirm clinical benefits such as improved survival. A global Phase III trial dubbed TROPiCS-04 is currently underway.

The Fda Grants The Treatment Breakthrough Therapy Designation

The FDA grants Breakthrough Therapy designation a process that expedites the development and review process for drugs that show significant promisefor the treatment.

This is based on data we had for 59 patients with metastatic cancer, all of whom had already failed one or more prior lines of treatment, De Porre explains. We found that 42% of people in this group were responders, which is very positive given the high unmet need in this population.”

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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.

Editorial Note On The Review Process

New treatments for bladder cancer patients

F1000 Faculty Reviews are commissioned from members of the prestigiousF1000 Faculty and are edited as a service to readers. In order to make these reviews as comprehensive and accessible as possible, the referees provide input before publication and only the final, revised version is published. The referees who approved the final version are listed with their names and affiliations but without their reports on earlier versions .

The referees who approved this article are:

  • Fumitaka Koga, Department of Urology, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan

    No competing interests were disclosed.

  • Mototsugu Oya, Department of Urology, Keio University School of Medicine, Tokyo, Japan

    No competing interests were disclosed.

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Fda Approves First New Bladder Cancer Treatment In 20 Years

The Food and Drug Administration granted approval for pembrolizumabmarketed as Keytruda and manufactured by Merckas an alternative to radical surgery in certain bladder cancer patients.

The anti-PD-1 therapy was approved as monotherapy for patients with Bacillus Calmette-Guerin -unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors who are not candidates for or opted not to undergo surgery. This is the first FDA-approved immunotherapy for inner layer bladder cancer in about 20 years, according to reports.

Todays approval of KEYTRUDA reinforces our companys commitment to expanding existing treatment options for certain patients with high-risk, non-muscle invasive bladder cancer, said Scot Ebbinghaus, MD, vice president, clinical research, Merck Research Laboratories, in a press release from the company. As the first anti-PD-1 therapy approved in this setting, KEYTRUDA will be a new clinical option for a patient population that previously had limited FDA-approved therapies available.

According to Merck, KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the bodys immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Checkpoint Inhibitors And Bladder Cancer

Long-term survival for people diagnosed with advanced bladder cancer is poor, with approximately 5% of patients with metastatic bladder cancer surviving for 5 years or more.

Checkpoint inhibitors have shown activity in patients with metastatic bladder cancer in both the second-line setting and the first-line setting , explained Andrea B. Apolo, M.D., who heads the Bladder Cancer Section in NCIs Center for Cancer Researchs Genitourinary Malignancies Branch.

But we still needand are awaitingthe results of ongoing randomized trials comparing checkpoint inhibitors and chemotherapy in the first-line setting for patients with metastatic bladder cancer, she continued. The results will allow us to adequately compare patient outcome in terms of survival and quality of life with these therapies.

With the exception of pembrolizumab, the drugs covered by these approvals target a protein known as PD-L1 that is expressed at high levels on some cancer cells. Pembrolizumab targets PD-1, the receptor protein for PD-L1, on immune cells. Normally, binding of PD-L1 to PD-1 tamps down immune activity. By preventing the interaction between PD-L1 and PD-1, all four drugs can allow the immune system to be more active against tumor cells.

The other checkpoint inhibitor approved by the FDA for the treatment of patients with bladder cancer, nivolumab , targets PD-1.

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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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If Treatment Does Not Work

Bladder Cancer

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.

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What Is Bladder Cancer

Bladder cancer – or urothelial cancer – is a common type of cancer. It most often begins in the cells that line the inside of the bladder, called urothelial cells. Urothelial cells are also found in other parts of the urinary system, such as the kidneys and the ureters. Urothelial cancer is found much more often in the bladder than in the other parts. But because people sometimes have tumors in these places, too, all of the urinary tract needs to be checked for tumors.1

Most bladder cancers are found at an early stage. When left untreated, tumor cells spread beyond the lining, into or through the other layers in the bladder wall. It then has a higher stage, becomes more advanced, and can be harder to treat.1

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  • 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

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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.

Current And Future Trends In The Bladder Cancer Treatment Paradigm

New Immunotherapy Approved for Metastatic Bladder Cancer

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.

TRANSCRIPTION:

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Fda Approves Padcev For Bladder Cancer

The US Food and Drug Administration has approved a new type of drug for certain people with bladder cancer. Padcev can treat people with advanced urothelial carcinoma, the most common type of bladder cancer, if it got worse after standard chemotherapy and immunotherapy treatments.

Padcev is a combination of 2 different types of drugs, called an antibody-drug conjugate. The antibody part acts like a homing signal, bringing the chemo drug, monomethyl auristantin E, directly to bladder cancer cells with a protein called Nectin-4 on them and killing them.

The FDA based its approval of this drug on a clinical trial of 125 people with advanced urothelial carcinoma who had already been treated with platinum chemotherapy and immunotherapy . Twelve percent of people had a complete response, meaning their tumors were no longer detectable, and 32% had a partial response, meaning their tumors got smaller but didnt disappear. The average amount of time the improvements lasted was 7.6 months. Patients get Padcev intravenously once a week for 3 weeks with 1 week off.

The FDA granted Padcev accelerated approval, priority review, and breakthrough therapy designations programs designed to speed up the availability of drugs to treat serious diseases. Another clinical trial will be required to confirm the results.

Padcev is marketed by Astellas Pharma US Inc.

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