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For patients with bladder cancer, being prescribed certain drugs may “take a village,” particularly for medications recently approved by the Food and Drug Administration (FDA), two experts told CURE®.

 for patients with metastatic bladder cancer with susceptible FGFR3 or FGFR2 alterations was an instance of the “village” it takes to prescribe the medication to eligible patients.

“There are a couple of additional steps with medications like [Balversa], compared to say a blood pressure medication or some of the more routine medications that patients might be on,” explained Kelli Rourke, a pharmacist with specialized clinical training in oncology at Johns Hopkins University School of Medicine, during an interview with CURE®.

“There is typically an insurance authorization step for these medications. And then once authorization is obtained from insurance, sometimes we run into issues with the cost,” she said. “Even when they're covered, we can still see really high copays for patients and out-of-pocket costs on these medications. So, these additional steps can cause some barriers or delays and getting the patient started on that medication.”

These additional steps taken before patients receive their prescribed drugs cause a whole team to become involved in the process, said Dr. Jean Hoffman-Censits, a doctor and associate professor of medical oncology and urology at Johns Hopkins Medicine, in the same interview.

“The first [step] is getting some additional information about the tumor to determine whether or not a patient really is eligible for this medication,” she explained. “One of the steps is that information has to be gotten and there's a few different ways that oncologists in general are getting this information. But that's either a send-out or we interface with the pathology team at the local hospital to get that information. It can take a few weeks to get back, so in the meantime, we're using other therapies.”

But the village also goes beyond just the doctors on the care team. Other specialists may be involved, depending on patient needs and the side effects they experience from the related drug.

Specifically with Balversa, Hoffman-Censits noted that a common side effect patients experience was higher levels of phosphorous. She said this would often lead to engaging with a dietician or nutritionist to help patients select the necessary food in their diets to balance and manage their side effects.

Balversa Fills a ‘Critical Need’ for Metastatic Bladder Cancer

When drugs are FDA-approved, it’s very common for doctors and pharmacists to want to get eligible patients started on the drug, Hoffman-Censits and Rouke agreed, but more steps are involved before the drug is even shipped.

“When a drug has a lot of promise, and you find out it's FDA approved, we as clinicians are eager to get that drug started. But the manufacturer may not have shipped it yet, or the insurer and the manufacturer may not even have a billing code for that drug yet,” said Hoffman-Censits. “Each institution has a pharmacy and therapeutics committee that has to approve that that drug is being used. So multiple different steps really have to come to pass.”

Additionally, Hoffman-Censits and Rourke noted that the timing of when patients can receive these drugs depends on whether the drug was ever approved before in a different indication.

“It can take some time if the drug has never been FDA approved, that's somewhat different than if a drug was approved for a different indication,” Hoffman-Censits said. “So for instance, in the past couple of years, [bladder] cancer has started using a drug that was previously FDA-approved for breast cancer. So all of those previous issues with the shipment and having the drug available and on a formulary (list of prescription drugs) were fine. And it's almost like you just opened a new door, and now a new group of doctors can use the medication.”

“Sometimes we want to just snap our fingers and be able to do the new things and kind of offer these new options to patients. But [also] recognizing that there can be a lot of steps when it is truly a new [drug],” Rourke added. “But [we recognize that] it can be a little bit more of a slow process when it's a truly new approval and a new indication kind of across the board.

For more news on cancer updates, research and education, don’t forget to 

Prescribing newly FDA-approved drugs may take a long time before patients can start taking them, so experts told CURE® why. 

Getting Newly Approved Cancer Drugs May ‘Take a Village,’ Experts Say

For patients who have received a diagnosis of bladder cancer, the conversations they have with their care team can be incredibly important, as one expert explained.

“Bladder cancer is really a heterogeneous disease. On one hand, you have a mild type of cancer, one you have a very aggressive life-threatening cancer. So, the conversations will be very different from each of these patients. What usually happens is that when the patient is initially diagnosed, they are usually managed by local urologist or a community urologist. But if they are diagnosed with aggressive cancers, that's when the conversations on other things become very important,” said Dr. Murugesan Manoharan.

Manoharan, surgical urologic oncologist and the chief of urologic oncology surgery at Miami Cancer Institute, as well as the chairman of the Department of Urology and Abbhi Family Endowed Chair in Urologic Oncology at Baptist Health South Florida and a professor of urology at Herbert Wertheim College of Medicine, Florida International University, explained four key questions patients should as their care team following a diagnosis of bladder cancer.

Does the facility have a multidisciplinary team and a tumor board?

“First of all, does that hospital or that center have what is called a multidisciplinary team, meaning the patient will be treated not alone by the surgeon, they will be treated with a medical oncologist, radiation oncologist, psychologist, many other support people”? said Manoharan. “So, [asking] ‘Do you have a team-based approach to deal with a bladder cancer?’ is the most important thing. Or, [is there] a single person who is making a decision?

“And along with those things, you need to know whether they have something called a tumor board, where the individual patient will be presented to a group of doctors from different specialties and they make a joint decision. That's the first question to ask, ‘Hey, do you have a multidisciplinary team and a tumor board or review system?’”

Learn More: Moving Into an Era of Targeted Bladder Cancer Treatments

Does the facility have access to clinical trials?

“Sometimes you have the long-standing old treatments, but the new treatments come through the clinical trials, [where] both the patient gets benefited and the patient also benefits the future generations to come,” said Manoharan. “So, whether that center has clinical trials or whether any clinical trials are available for that particular patient is a second important question I'd ask.”

Does the provider have access to the latest technological advancements?

“[With] scientific advances many things, [such as] CT scans, PET scans, have changed and the treatment has changed. So, we need to know whether that particular doctor or the center has access to new technological advances,” said Manoharan.

Learn More: Answering the Call for Bladder Cancer Support

Is there a patient support group available?

“Doctors like us, we do not know how to be a patient,” Manoharan said. “We can understand, but we have never been a patient, whereas in a support group, a patient who underwent chemotherapy and even surgery, they all will be there. If there is a patient support group there, this particular patient can join them and [patients can] speak to each other and get to know more about the disease and how to cope with things.”

Dr. Murugesan Manoharan of Miami Cancer Institute and Baptist Health South Florida shares key questions patients who have received a diagnosis of bladder cancer should ask their care team.

4 Questions to Ask After a Bladder Cancer Diagnosis

Dr. Andrea Apolo at the 2024 Genitourinary Cancers Symposium, discussing Keytruda (pembrolizumab) side effects in bladder cancer

Keytruda Side Effects: 'If Something Doesn't Feel Right ... Call'

Patients with bladder cancer who are being treated with the immunotherapy agent, Keytruda (pembrolizumab) should always reach out to their oncology team if they are experiencing side effects, explained Dr. Andrea Apolo.

In a recent interview at the 2024 Genitourinary Cancers Symposium, Apolo, who is the head of the Bladder Cancer Section of the Genitourinary Malignancies Branch and Director of the Bladder Cancer and Genitourinary Tumors Multidisciplinary Clinic in the Center for Cancer Research of the National Cancer Institute, discussed findings from the phase 3 AMBASSADOR Alliance A031501 trial, which investigated Keytruda in patients with muscle-invasive, locally advanced bladder cancer.

Findings showed that Keytruda outperformed observation when it came to disease-free survival. While the study determined that the immunotherapy agent was safe and tolerable, immunotherapy drugs such as Keytruda can come with side effects that patients should speak up about, according to Apolo.

Keytruda works by inhibiting a certain protein — also called a checkpoint — that helps cancer cells hide from the immune system. Once that checkpoint is blocked, the immune system can better find and destroy tumor cells.

Keytruda Has Received Nearly 40 FDA Approvals. How Does It Work?

In sparking an immune response, the drug can also cause immune-related side effects that can affect any part of the body, and are crucial to bring up to the care team.

Anytime something doesn't feel right, patients should call their oncologist just to be evaluated, be seen (and) have labs drawn, because the toxicity of (Keytruda) and other checkpoint inhibitors are very nonspecific. They affect the immune system, and the immune system is all over our body so it can affect any organ in the body.

So if something doesn't feel right, it's time to call the if you're on treatment with (Keytruda) it's time to call the medical oncologist or go in, get a full exam, be assessed and get some labs.

Patients with bladder cancer being treated with the immunotherapy agent, Keytruda, should not hesitate to call their oncology team if something does not feel right, an expert said. 

Keytruda Side Effects: ‘If Something Doesn’t Feel Right … Call’

There are so many types of treatment for bladder cancer, which can make it a challenge to understand what is available and most effective for you. So, CURE® spoke with two bladder cancer experts to discuss different types of treatments for bladder cancer.

Bladder cancer, according to the American Cancer Society, is when cells that form the urinary bladder begin to grow uncontrollably. When these cells continue to grow, it can turn into a tumor that may eventually spread to other parts of the body.

The cancer is classified based on how deeply the tumor has spread within the bladder walls, which includes muscle-invasive and non-muscle-invasive bladder cancer. Muscle-invasive bladder cancer is when tumor cells have invaded the muscle layer responsible for expelling urine, Dr. Petros Grivas from Fred Hutchinson Cancer Center, explained in an interview. Similarly, he noted that non-muscle-invasive bladder cancer is when the tumor has not yet been embedded into the muscle layer, thus it is more superficial.

Grivas is a medical oncologist, professor and clinical director of genitourinary cancer programs at Fred Hutchinson Cancer Center and the University of Washington.

Differentiating Muscle-Invasive and Non-Muscle-Invasive Bladder Cancer

Different types of treatments are related to the stage of bladder cancer, Grivas said, and the extent of the cancer. Factors include the depth of the tumor into the bladder wall, whether it may be expanding into nearby lymph nodes and/or potential metastasis (spread) to other parts of the body, and “we also take into account what exactly the cancer looks like; how it looks under the microscope,” Grivas stated.

Types of treatment for bladder cancer include systemic (full body) therapies, such as chemotherapies and immunotherapies, which stimulate the immune system, as well as targeted or biologic therapies, Grivas said.

Specifically, combination therapies are widely used, which may include various types of chemotherapies.

“(Treatment with) methotrexate, Vinblastine, Adriamycin (doxorubicin) and cisplatin — the MVAC regimen — has shown to improve survival (or the longevity and chance of a cure) in patients with localized muscle-invasive bladder cancer before a radical cystectomy (surgical removal of the whole bladder), called neoadjuvant treatment,” Dr. Shifeng Mao, a medical oncologist, associate professor and chair of the urological oncology team at Allegheny Health Network Cancer Institute, explained in a separate interview.

A radical cystectomy is a type of procedure or surgery known to be standard-of-care for patients with muscle-invasive bladder cancer, Mao said, and “has saved a lot of patients’ lives.”

Mao said that although doctors have learned that by “doing radical cystectomy alone, (about) half of the patients will find that (the cancer may) recur later on,” meaning the surgery alone may not be enough for optimal treatment in some patients. "This is why we are using neoadjuvant chemotherapy before radical cystectomy in eligible patients. Survival has improved significantly." 

Mao also noted that the four chemotherapies are now dose-dense when given to patients, meaning using “less of methotrexate and Vinblastine, but increasing the dose density of the more important drugs, which are cisplatin and Adriamycin.”

"By doing so, the treatment response is better, side effects are less and takes less time to complete a treatment course," he explained.

When MVAC isn’t the best option for patients with localized muscle-invasive bladder cancer, a combination of gemcitabine and cisplatin — two other chemotherapy drugs — is used in eligible patients. Mao stated that the gemcitabine-cisplatin combination has gained popularity among the clinical setting, as it has potentially less toxicities compared with MVAC, although dose-dense MVAC is much easier compared to the previous MVAC version.

In terms of knowing which patients are best fit for neoadjuvant chemotherapy, Mao explained that criteria are considered before choosing appropriate treatment for every patient and that doctors can’t “treat patients only by the book,” but also consider individual characteristics and several factors.

“To decide whether patients are eligible for (particular) chemotherapy before surgery, (for example), patients have to be cisplatin eligible, so that depends on several criteria,” Mao advised. “One: kidney function, and two: heart function, because cisplatin requires a lot of fluids, so if you overload the patient and they could develop heart failure, they cannot tolerate (it all). And three: poor performance (or functional) status. If a patient spends most of their day sitting in a wheelchair or lying in bed, then they may not be a good candidate for chemotherapy.”

Other factors include considering whether patients have neuropathy — or severe nerve damage — or hearing loss, Mao said.

Grivas also explained that doctors “discuss (these topics) with patients in detail and they together make these decisions, taking into account many cancer-related and patient-specific characteristics” of the patient they are treating.

“There is a plethora of therapy options, including trying to preserve the bladder in certain cases and scenarios, and we try to make them tailored, (so we can make a) customized and personalized decision,” Grivas said. “Utilizing some of those (therapies), or sometimes more than just one of those therapy tools, to treat the patient is based on the right diagnosis, other (possible) medical conditions, performance or functional status, patient preferences, etc.”

It’s important to know what kinds of treatments are available for bladder cancer and understand that having a “tailored” treatment is important for patients, experts said.

Having a ‘Tailored’ Treatment for Bladder Cancer is Crucial

Dr. Petros Grivas discussed differences between muscle-invasive and non-muscle-invasive bladder cancer.

Differences Between Muscle-Invasive and Non-Muscle-Invasive Bladder Cancer

The “stage” (spread) of bladder cancer may vary from patient to patient, so it’s important to understand the difference between muscle-invasive and non-muscle-invasive bladder cancer.

Between muscle-invasive and non-muscle-invasive bladder cancer, “the main difference has to do with the depth of the cancer invasion within the bladder wall,” Dr. Petros Grivas, a medical oncologist, professor and clinical director of genitourinary cancers program at Fred Hutchinson Cancer Center and the University of Washington, explained during an interview with CURE®.

He noted that once tumor cells have entered the main muscle layer of the bladder wall, it becomes muscle-invasive bladder cancer.

However, non-muscle invasive bladder cancer is when the tumor has not yet entered the main muscle layer of the bladder wall, Grivas said, which he described as “more superficial,” meaning the tumor is at a surface layer near the lumen of the bladder.

A way to determine whether a patient has muscle-invasive or non-muscle-invasive bladder cancer includes a cystoscopy, known as a procedure that looks inside the bladder via a thin tube with a small video camera attached to the end, as the American Cancer Society defines.

The cystoscopy is combined with the surgical removal of the tumor by the urologist with a very careful assessment of the tumor specimen by a pathologist. The procedure, called “TURBT,” may need to be repeated in certain cases aiming for accurate “staging.”

The results from a tumor removal are discussed between a pathologist (scientist studying diseases often using a microscope) and a urologist (doctor specializing in urinary tract conditions) to “help us in that staging, meaning how extensive the cancer is, while examining the patient and also looking at the scans (imaging) is also critical for that assessment,” Grivas explained.

The main difference has to do with the depth of the cancer invasion within the bladder wall. If we think about the bladder cancer arising in the internal part of the bladder — what we call the lumen — where the urine is being collected, this tumor usually can make its way towards the external part of the bladder. So, it starts invading the different layers of the bladder wall and one of those main middle layers in the middle of the way is called muscle or muscularis, (

”) term, but let's think about it as the muscle that makes the bladder contract and to send the urine out for urination. So that muscle layer, if it's invaded by the tumor cells, that makes it muscle invasive.

And that's relevant for therapy implications. Because of that particular muscle layer has also little blood vessels and little (“lymphatic”) spaces that may actually generate a risk of cancer cells leaving the bladder and finding an avenue to escape and cause what we call metastasis. So, because of that, we have to think about not only what we see in the CT scan, for example, but also any potential microscopic cells that may or may not be present (elsewhere) in the body.

That's why the muscle layer invasion is important. And we may have a medical oncologist like myself be involved in the (evaluation and possible) treatment of the patient (in addition to urologist, radiation oncologist, etc.) On the contrary, non-muscle-invasive is pretty much when the bladder cancer is more “superficial,” so it has not yet invaded the muscle layer (and remains in) the more “superficial” layers of the bladder.

There are three different types of non-muscle invasive bladder cancer 

) and the urologist who does the exam, cystoscopy and tumor removal looks inside the bladder and takes the cancer out. This goes to pathology and the pathologist along with a urologist can help us in that staging, meaning how extensive the cancer is.

And the T stage — T for tumor — can help us understand if it's muscle-invasive or not, depending on the depth of invasion, we also take into account the CT scan (imaging studies) that we do and also the exam that the urologist does when they remove the tumor (from the bladder using) a camera (inserted) inside the bladder. All of the above factors can help us figure out the (“clinical”) stage, including the muscle invasion.

Transcript has been edited for clarity and conciseness.

When it comes to bladder cancer, it’s important to note the differences between muscle-invasive and non-muscle-invasive bladder cancer, as it can affect the staging of the cancer.

Differentiating Muscle-Invasive, Non-Muscle-Invasive Bladder Cancer

Despite being the tenth most common type of cancer worldwide in terms of new cases per year, not a lot is heard about bladder cancer in either the media or on social media feeds. Fortunately for those afflicted by bladder cancer (BC), lots of research has been conducted on this disease that had as many as 550,000 new cases and 200,000 deaths in 2018 alone. While men are about 4 times as likely than women to be diagnosed with this disease, its mortality rates are equal, indicating women are more likely to have an aggressive form of BC. Today, we’d like to take some time to talk about the 

, as well as current research into more effective bladder cancer treatments.

Bladder cancer is typically broken down into two subtypes – muscle-invasive bladder cancer (MIBC) and non-muscle invasive bladder cancer (NMIBC). The names are pretty self-explanatory, with the first type more likely to invade the musculature of the bladder than the second. While MIBC is a more aggressive and more lethal form of the disease, NMIBC is much more likely to have recurrences. MIBC represents approximately 20% of new diagnoses of all bladder cancers.

Differentiating the survival rates for the two sub-types of bladder cancer is tricky, as many cancer registries don’t list them separately. As such, the two types are lumped in as one under the blanket term bladder cancer. When caught early, either remaining in the bladder or only local spread, the five-year survival rates are 96% and 70%. As the disease progresses to regional spread and distant spread, the survival rates drop to 36% and 5%.

By far, the number one cause of bladder cancer is tobacco use. For more information on this link, please see “

A look at new research and discoveries in the field of bladder cancer By Kathryn E. Vinson, MS, CCRC Despite being the tenth most common

Bladder Cancer

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