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Dr. Michael J. Pishvaian is based at Sibley Memorial Hospital in Washington, D.C. He is the director of Gastrointestinal, Developmental Therapeutics and Clinical Research Programs for the Johns Hopkins Kimmel Cancer Center in the Greater Washington Area and an associate professor at the School of Medicine.

There are a number of reasons why patients with cancer are encouraged to enroll in clinical trials, Dr. Michael J. Pishvaian explained.

The Benefit of Clinical Trial Enrollment for Patients With Cancer

Among patients with previously untreated chronic lymphocytic leukemia (CLL), Calquence (acalabrutinib) plus Venclexta (venetoclax) with or without Gazyva (obinutuzumab) significantly prolonged progression-free survival when compared with chemoimmunotherapy, according to study findings published in 

After a median follow-up of 40.8 months, the estimated 36-month progression-free survival was 76.5% with Calquence and Venclexta, 83.1% with Calquence plus Venclexta and Gazyva, and 66.5% with chemoimmunotherapy. Estimated 36-month overall survival was 94.1% with Calquence plus Venclexta, 87.7% with the Calquence combination and 85.9% with chemoimmunotherapy.

“Results for progression-free survival suggest that the benefit of adding [Gazyva to Calquence and Venclexta] was most apparent in the subgroup with unmutated IGHV, which had results that were similar to those in the subgroup with mutated IGHV,” Dr. Jennifer R. Brown and colleagues wrote in the study. “In addition, overall survival was significantly prolonged with [Calquence plus Venclexta] as compared with chemoimmunotherapy.”

Brown is the director of the CLL Center of the Division of Hematologic Malignancies at Dana-Farber Cancer Institute and the Worthington and Margaret Collette Professor of Medicine in the Field of Hematologic Oncology at Harvard Medical School in Boston.

Side effects leading to discontinuation of Calquence occurred in 7.6% and 13.7% of patients in the Calquence plus Venclexta, and Calquence plus Venclexta and Gazyva groups, respectively. Dose reduction occurred in 14.1%, 20.8% and 11.2% in the three groups. Infections and neutropenia were the most common reasons for treatment interruption and dose reduction.

Serious side effects were reported in 24.7%, 38.4% and 27.4% of patients in the three groups. Cardiac events and second primary cancers were more common in the Calquence plus Venclexta (9.3% and 5.2%) and Calquence plus Venclexta and Gazyva (12% and 4.2%) groups compared to the chemoimmunotherapy group (3.5% and 0.8%). Basal cell and squamous cell carcinomas occurred more often in the Calquence plus Venclexta group.

Hypertension occurred in 4.1%, 3.9% and 2.7%, and grade 3 (severe) or higher neutropenia was reported in 32.3%, 46.1% and 43.2%. Tumor lysis syndrome was observed in 0.3%, 0.4% and 3.1% of patients.

Deaths from any cause were reported in 18, 37 and 42 patients in the three groups, with COVID-19-related deaths occurring in 10, 25 and 21 patients, respectively. Of the 56 COVID-19-related deaths, 48 occurred in 2020 and 2021.

“The safety profile of fixed-duration [Calquence plus Venclexta] in this trial aligned with that in previous studies of [Calquence],” study authors wrote.

A total of 867 patients were randomized with 291 assigned to Calquence plus Venclexta, 286 to Calquence plus Venclexta and Gazyva and 290 to chemoimmunotherapy. Of those in the chemoimmunotherapy group, 143 received fludarabine and cyclophosphamide and rituximab and 147 received bendamustine-rituximab. The median patient age was 61 years, and 58.6% had unmutated IGHV.

This phase 3 open-label trial enrolled patients 18 or older with an Eastern Cooperative Oncology Group performance-status score of 0 to 2 and no 17p deletion or TP53 mutation. Participants were randomly assigned to receive either Calquence plus Venclexta (Calquence in cycles 1 to 14; Venclexta in cycles 3 to 14), Calquence plus Venclexta and Gazyva (same regimen with Gazyva in cycles 2 to 7) or chemoimmunotherapy with fludarabine and cyclophosphamide and rituximab or bendamustine and rituximab (cycles 1 to 6), as chosen by investigators.

“Fixed-Duration Acalabrutinib Combinations in Untreated Chronic Lymphocytic Leukemia,” by Dr. J. R. Brown, et al

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In a study of untreated chronic lymphocytic leukemia (CLL) patients, Calquence (acalabrutinib) combined with Venclexta (venetoclax), with or without Gazyva (obinutuzumab), significantly improved progression-free survival compared to chemoimmunotherapy. The 36-month progression-free survival rates were 76.5% for Calquence and Venclexta, 83.1% with Gazyva, and 66.5% for chemoimmunotherapy. Overall survival was also higher in the Calquence groups. Side effects included infections, neutropenia, cardiac events, and secondary cancers. The study involved 867 patients, with a median age of 61, and highlighted the safety profile of the treatment.

Calquence plus Venclexta with or without Gazyva significantly improved progression-free survival in patients with untreated CLL. 

Tumor

Calquence Combo May Improve Outcomes in Chronic Lymphocytic Leukemia

As a cancer veteran, I'm witnessing some beautiful things going on in the lives of people I know with cancer. And I'm learning that life does go on despite an often-wicked diagnosis.

For instance, Jean, a friend of mine, has stage 4 thyroid cancer, but thank God the cancer isn't getting any worse. At least that's what her frequent scans say. Even though she has this cancer diagnosis hanging over her head, she doesn't let it keep her from living her life. In fact, she is the family "ringleader," as her cousin describes her. She gives many of the parties and tries to keep their family together. A job that once belonged to the family's paternal grandmother, Jean is the hostess who throws frequent get-togethers for family and friends. When I'm in New York, I often attend a gathering at her home. Jean is one of the most cordial and welcoming people I know.

My brother, who was recently diagnosed with stage 1 Waldenstrom, a type of non-Hodgkin's lymphoma, is the chief caregiver of our 93 year-old mother, who has Parkinson’s disease. He helps her with her daily care such as bathing, dressing, and preparing meals. It's Mike who puts my mother to bed at night. Mike and my mom live a quiet life; they are known to take long drives during the day and watch Lawrence Welk nightly. His primary role is to keep her from falling. About a year ago, Mom fell, due to Parkinson’s, and broke her hip. Mike tries hard to prevent this from ever happening again, but sometimes a fall comes out of nowhere. The other day, it was so windy outside that a gust of wind knocked Mom over. Luckily, she wasn’t hurt in the fall.

Another friend of mine, Maggie, has breast cancer, stage 1. Years ago, Maggie and her husband, Robert, divorced, but Robert is currently helping Maggie through her cancer. In fact, Maggie’s cancer is, in a way, bringing the ex-couple closer. Robert is accompanying her to radiation treatments. A couple once alienated from each other, now can work together to keep Maggie alive.

Another couple I know share something in common: they both have cancer. The husband has prostate cancer, and the wife has breast cancer. They take care of each other, watching what they eat and exercising together as much as they can. This couple doesn’t let the disease slow them down, but the hardship seems to make them love each other even more.

In short, for some, cancer brings out resiliency and fellow feeling; for some, cancer may make some folks unsinkable and incredibly psychologically strong.

Ironically, for me, cancer did the opposite. I was laid low by my stage 2 breast cancer. The thought of throwing a party during that time was unthinkable. As far as caring for people, I could hardly care for my young son. This might have been because I was also dealing with bipolar disorder. I was both physically and mentally impaired. Thank God my husband was there to do the hard work of keeping the family together as I endured a double mastectomy, chemotherapy, and radiation therapy.

However you are going through cancer, whether you're thriving with the disease or just barely making it, I wish you the best. God knows it's hard either way. I hope your life goes on.

Cancer can evoke resilience and empathy, as seen in individuals who continue to live fulfilling lives despite their diagnoses. Examples include a woman with stage 4 thyroid cancer who remains a family leader, a man with stage 1 Waldenstrom's lymphoma caring for his elderly mother, and a divorced couple reconnecting through breast cancer treatment. Another couple supports each other through their respective cancer battles. While some find strength and connection, others, like the author, may struggle due to additional challenges such as mental health issues.

I reflect on how cancer has brought out resilience and support in others, even as I struggled with my own battle, and wish others strength in their journeys.

Life Goes On, Even With Breast Cancer

I was diagnosed with diabetes at the age of 60. Ten years later, I was diagnosed with chronic lymphocytic leukemia. When my primary care physician diagnosed me as diabetic, it wasn’t a shock because my father was diagnosed at the age of 20, while in the Army. I always knew I had a 50/50 chance of becoming diabetic because this was part of my family history. With that in mind, I worked hard to exercise, eat right, and watch my weight. And I always followed up with yearly checkups.

However, when the reality hit me, I became angry and depressed. I couldn’t understand how this could happen to me since I’d done all the right things, especially keeping my weight under control. I’m a medium-frame guy, 5 feet, 8 inches tall, and for my entire adult life, I’ve weighed between 140 lbs. and 150 lbs. But then I realized that genetics plays a big role in my makeup, so I was predisposed to diabetes from the very beginning. There was one thing that helped me to deal with my depression. My primary care physician called me in for a consultation and said the following:

“Chester, just think, you’ve been free of diabetes for 60 years. So, let’s focus on all those years and how grateful you can be for that. Since your father was diabetic, the family genetics were not on your side.” At that moment, his words hit me, and my spirits were lifted. He said, “I’ve been your doctor for 20 years, and I know you can cope with this. You have the strength. I know this about you.” It’s amazing how the words of a doctor can inspire us and encourage us to do the right thing.

The next time I went for a checkup, my A1C was perfect, and my PCP was proud of me. His support meant everything to me.

Then over the past few years, cancer came into my life and uprooted my balance. I felt as if I was walking a tightrope and tilting over all the time to hold myself together.

In doing some research, I discovered that diabetes itself can make us vulnerable to other diseases. Then I discovered that my medication, metformin, could make me susceptible to other cancers such as prostate, colorectal, and even breast cancer. There is controversial research about this drug, but I’m still taking it and hoping it helps. I’m also taking Jardiance, which reduces the risk of cardiovascular and kidney disease. But it too has a harmful side effect of causing ketoacidosis. Fortunately, I haven’t experienced that side effect. Either way, it means that I’m in a precarious position. It's like a double whammy!

When I began chemotherapy for my chronic lymphocytic leukemia, I learned more lessons, which were outlined in my essay, “What I’ve Learned about Having Cancer.” My oncologist prescribed medication for nausea and vomiting before the chemotherapy started. Fortunately, that worked, and I didn’t experience any of those symptoms. However, the very medication that was used to treat my cancer was also raising my blood glucose level.

Eventually, my oncologist and primary care physician worked together and prescribed Ozempic. This medication resulted in weight loss to the extent that the doctors discontinued that medication. I was never overweight, and this weight loss began to make me look like a skeleton.

My primary care physician changed the medication to Trulicity, and my A1C lowered somewhat. But now that I’ve completed the second round of chemotherapy, my diabetes has gotten out of control, and my A1C is up again. When I met with my primary care physician, I told him I hadn’t been eating right. I do walk every day for my exercise, but I realize the real issue is diet.

My partner also has metastatic prostate cancer, and both of us were scammed by contractors who worked on our new home. The loss of money from that and dealing with both of us being ill has increased my stress. As a result, I’m stress eating. I know this is something I shouldn’t do, but I’m finding it difficult to stop. I’m injecting myself with insulin each day now. I also have a continuous glucose monitor, which makes me aware of my blood glucose level, whether I like it or not. I’ve learned that taking a large dose of vitamin C can cause a false reading on the glucose monitor, so I try to be aware of that when taking multivitamins or eating oranges. Currently, I’m trying to find a way to improve my condition.

I’m a Quaker, and we normally don’t observe Lent. However, since it’s a time of self-reflection and evaluation, I’m using this Lenten season as a way of disciplining myself and trying to get myself under control. When I was a chaplain in the college setting, I used to conduct ecumenical services during Lent. The students would ask each other what they were giving up for Lent. However, I don’t want to focus on giving up something. I’d rather put my energy into trying to change my diet and eating habits. During this Lenten season, I’m trying to improve myself, both on a spiritual and a psychological level. I want to add courage, faith, and strength to my body, mind, and spirit. We all have to find a way to cope, and everyone has to find their own way. This is what I’m trying to do.

Navigating two diagnoses of diabetes and cancer is difficult. It involves making a lifestyle change. I made that change years ago, but I’ve drifted away from it. So, now I need to consult with a dietitian and try to manage my eating habits. I need to focus on eating fresh vegetables, whole grains, fruits, and low-fat dairy products as well as lean meats. This type of diet will help reduce my risk of heart and kidney disease since I’m prone to those conditions in my situation. I try to stay well hydrated because some of my medications can. Be hard on the kidneys and liver. I’m an herbal tea lover and drink lots of it, along with spring water.

The latest cancer research shows that eating salmon and tuna can help boost my immune system. I have discovered a new cereal called “Nutrail Blueberry Cinnamon.” It has 2 grams of net carbs and 2 grams of total sugars. It is 160 calories per serving. It tastes great and has pecans, sunflower seeds, pumpkin seeds, almonds, coconut, dried blueberries, cinnamon, butter, salt, and monk fruit extract. It even has 3 grams of dietary fiber. It has been hard to find a cereal for breakfast without tons of sugar. This find is a real joy for me. New studies on red wine suggest that, instead of being anti-inflammatory and supporting heart health, all wine can contribute to cancer. This was disappointing news as I loved to have a glass of red wine with dinner on Sunday nights. That was one of my little delights.

As I look back on my cancer journey, there are other areas of concern that have been beneficial to me. I need to seek out a massage therapist to assist with the stress in my life. When I was first diagnosed with cancer, the hospital provided free massage therapy once a week. Since it was a great benefit to me in the past, I think I should return to this as a way to deal with my stress level. The main thing that has kept me going thus far is my practice of mindfulness meditation. It has been a lifesaver.

I’m always proactive with my medical team. I make copies of my current test results and medical notes to take to my appointments. Additionally, I make sure that one is up to date and on the same page. I include my medical oncologist/hematologist, radiology oncologist, pharmacological specialist, nutritionist/dietitian, and primary care physician. I always type a list of questions to have ready, so I can give them to my oncologists at my appointments. By addressing all these concerns, I will improve my diabetes as well as my cancer.

In all honesty, I must admit that I’m struggling right now, but I’m trying to make baby steps in the right direction every day. Hopefully, my faith will be a bulwark for me to lean on. I’ve made it this far, and maybe I can make it further in my journey of managing both diagnoses. Coping with diabetes and cancer is like walking a tightrope. It’s a balancing act, but being careful and health-conscious will allow me to succeed.

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Managing dual diagnoses of diabetes and chronic lymphocytic leukemia presents significant challenges, requiring lifestyle adjustments and medical interventions. Despite a family history of diabetes, proactive health measures were initially effective. However, the onset of cancer and its treatment complicated diabetes management, necessitating medication adjustments and dietary changes. Stress, exacerbated by personal and financial issues, further impacted health. Emphasizing mindfulness, spiritual reflection, and a supportive healthcare team, the journey involves continuous adaptation and resilience. The focus remains on balancing medical treatments, diet, and mental well-being to navigate this complex health landscape.

Managing diabetes and chronic lymphocytic leukemia is challenging, but with proactive care, mindfulness and diet changes, I'm working to balance both.

Navigating a Diagnosis of Diabetes and Chronic Lymphocytic Leukemia

Have you ever wondered what life lessons you will experience after a diagnosis of colon cancer? Well, I would have never guessed that this question would be a part of my adventure. Being diagnosed with colon cancer in my early thirties was definitely not a thought in my mind. However, when the doctor informed me of my prognosis, I took the news with my head held high as I knew that my family needed me. I had to stay strong and courageous, as I was an inspiration to those around me. I did not have the heart to disappoint themost important people in my life, especially my parents. I wanted to set an example that fighting for your life is worth every sacrifice.

For this reason, as difficult as it was, I knew that having peace of mind as well as empowerment of positive thinking was one of the best remedies to overcome this life changing event.

Now you may ask, “What are some of these life lessons that you can learn from after going through a cancer journey?” My immediate response is the power of self-love. Loving yourself is the best gift you can endure. Before my diagnosis with colon cancer, I thought that I loved myself, yet this experience taught me the true meaning of self-love. What do I mean with this phrase? It is as simple as saying, “I am always putting myself first no matter what.” Also, it is stating, “It is ok to say no and not feel guilty about it.” Now, this does not mean that you are selfish and that you would not be there for the people that you care about. It is simply that youneed to take care of yourself first before you can take care of others.

Additionally, another life lesson that I was able to gain an understanding of was getting out of my comfort zone. This has been an area where I have genuinely struggled. Ever since I can remember, I always liked conformity and did not like change or try new things. Yet, after my diagnosis, I began to explore and became more open minded. I started to do things on my own and not depend on others. For example, I attended a women’s retreat in Upstate New York, where I was able to reconnect with myself on a much deeper level. At the same time, I met incredible, powerful women that I learned so much from. I would have never gone on my own, but I have become braver, and I am not scared to do things alone. If anything, I have acquired positive experiences and have grown exceedingly.

To sum it up, these past few years have been bittersweet, yet I would do it all over again for the simple fact that because of my colon cancer voyage, I have become my highest, truest expression of myself. I have acquired a knowledge of experiences where my life lessons assisted in helping me grow in all areas of my life. By going through this path, I have gained insight of who I am meant to be along with where I want to go.

With that being said, I want to take this opportunity to express my gratitude. Thank you for taking the time toread my blogs. It is a blessing to be sharing my story with you. I hope and pray that my memoir be an inspiration that anything is possible as long as you believe. May God continue to bless you with an abundance of love, prosperity, health, success, but above all happiness. Forever Blessed!

A colon cancer diagnosis in one's early thirties can be life-altering, prompting profound personal growth and self-discovery. Embracing self-love and prioritizing personal well-being become essential, as does stepping out of comfort zones to explore new experiences. This journey fosters resilience, courage, and a deeper understanding of oneself, ultimately leading to personal empowerment and fulfillment. The experience, though challenging, is transformative, offering valuable life lessons that contribute to personal development and a renewed sense of purpose and direction.

After being diagnosed with colon cancer, I learned the life-changing lessons of self-love, stepping out of my comfort zone and embracing positive thinking.

Life Lessons I Learned After My Colon Cancer Diagnosis 

The European Commission has granted marketing authorization to Rytelo (imetelstat) monotherapy for the treatment of adult patients with transfusion-dependent anemia due to very low–, low– or intermediate-risk myelodysplastic syndromes (MDS), according to a press release from Geron Corporation. Moreover, this regulatory decision has approved the agent for patients without an isolated deletion 5q cytogenetic abnormality, as well as those who are ineligible for or did not respond to erythropoietin-based therapy.

 in the European Union and is backed by data from the phase 3 IMerge clinical trial, which had significant clinical benefit in this patient population, reducing their need for red blood cell transfusions in the first 24 weeks of treatment versus placebo.

Regarding safety, the agent was described to have had manageable and short-lived side effects, including thrombocytopenia and neutropenia. These side effects occurred at grade 3 (severe) or higher in 69% and 63% of patients, respectively, and at a median duration of less than two weeks. In more than 80% of patients, the side effects were resolved to a grade less than 2 (moderate) in under four weeks.

“As the first and only treatment of its kind, Rytelo represents an important new option — significantly reducing the need for red blood cell transfusions for people living with lower-risk MDS who are battling debilitating symptoms like anemia and fatigue,” said Dr. Joseph Eid, Geron’s executive vice president of Research and Development. “This approval from the European Commission, just nine months following approval in the U.S., underscores the positive benefit for these patients demonstrated in our clinical trials and we look forward to making this innovative therapy accessible to eligible patients in Europe.”

Rytelo represents the first and only telomerase inhibitor — a compound that blocks or slows down the enzyme which cancer cells often use to keep growing — that is approved by the European Commission.

The regulatory approval applies to all 27 European Union member states, as well as Iceland, Norway and Liechtenstein, according to the press release. Moreover, Geron plans to make Rytelo available in other European countries starting in 2026, pending approval for coverage in each country. The company is also looking into special programs that could help eligible patients access Rytelo on a case-by-case basis.

 is a type of blood cancer that often will progress (worsen) over time, leading to symptoms like anemia and fatigue. Many patients eventually require frequent red blood cell transfusions, which can impact quality of life and shorten survival. Because of these outcomes in patients, there is a need for better treatment options, especially for patients with a poor prognosis, as current therapies are limited.

Investigators aimed to address this unmet medical need with Rytelo in the phase 3 trial. The investigative agent is a targeted therapy — 

 — for adults with lower-risk myelodysplastic syndromes who have anemia requiring frequent red blood cell transfusions and have not responded to or cannot receive standard treatments. It is given as an intravenous infusion over two hours every four weeks. 

The agent works by blocking telomerase, an enzyme that helps abnormal bone marrow cells keep dividing. By inhibiting this process, Rytelo may slow disease progression. Notably, it is also the first and only telomerase inhibitor approved by the U.S. Food and Drug Administration (FDA).

“I am thrilled that the European Commission has approved Rytelo in lower-risk MDS. The long-term and durable responses observed in the phase 3 IMerge study reinforce the practice-changing potential of telomerase inhibition as a clinically meaningful and differentiated option for the treatment of lower-risk MDS,” said Dr. Uwe Platzbecker, IMerge investigator and a co-lead author of the phase 3 results published in 

. “Physicians and patients in Europe are now one step closer to accessing a novel treatment that, in addition to having a generally manageable safety profile, has the potential to provide extended and continuous red blood cell transfusion independence.”

Platzbecker is also the chief medical officer at the University Hospital Carl Gustav Carus Dresden in Germany.

According to the press release, Rytelo can lower platelet levels, which may increase the risk of bleeding. A patient’s doctor is expected to monitor their blood counts regularly and may delay or adjust treatment if needed, though platelet transfusions may be given if necessary. Additionally, Rytelo may also lower neutrophil levels, which help fight infections. A doctor should your check a patient’s blood counts often and monitor for infections, including sepsis. If needed, medications to boost white blood cells or prevent infections may be given.

Some patients may also experience reactions during or after Rytelo treatment, such as headache or, in rare cases, high blood pressure. To help prevent this, patients can receive medications like diphenhydramine and hydrocortisone before treatment.

Serious side effects occurred in 32% of patients receiving Rytelo. These included infections like sepsis (4.2%), fractures (3.4%), heart failure (2.5%) and bleeding (2.5%). Fatal reactions were reported in 0.8% of patients, primarily due to sepsis. The most common side effects (reported in at least 10% of patients and more frequently than with placebo) included low platelets, low white blood cells, increased liver enzymes, fatigue, muscle or joint pain, prolonged blood clotting times, COVID-19 infections and headache. 

Rytelo (imetelstat) has received marketing authorization from the European Commission for treating transfusion-dependent anemia in adults with low-risk myelodysplastic syndromes (MDS) without isolated deletion 5q. This approval, supported by phase 3 IMerge trial data, highlights Rytelo's efficacy in reducing red blood cell transfusion needs. As the first telomerase inhibitor approved in the EU, Rytelo offers a novel treatment option with manageable side effects. Geron plans to expand Rytelo's availability across Europe by 2026, pending coverage approvals in individual countries.

The European Commission has approved Rytelo treatment in transfusion-dependent anemia due to very low–, low– or intermediate-risk myelodysplastic syndrome.

EU Approves Rytelo for Transfusion-Dependent Anemia in Low-Risk MDS

The U.S. Food and Drug Administration has approved neoadjuvant treatment with the immunotherapy agent Imfinzi (durvalumab) plus gemcitabine and cisplatin, followed by single-agent, adjuvant Imfinzi following radical cystectomy in adult patients with muscle invasive bladder cancer, the regulatory agency announced.

The efficacy of neoadjuvant Imfinzi was evaluated in 

, a randomized, open-label, multicenter investigation which enrolled 1,063 patients who were candidates for radical cystectomy (surgery to remove the urinary bladder) and had not yet received prior systemic therapy for their cancer. The trial randomized patients to receive either neoadjuvant Imfinzi with chemotherapy followed by adjuvant Imfinzi after surgery or neoadjuvant chemotherapy followed by surgery alone.

During a pre-specified interim analysis of NIAGARA, the investigative combination demonstrated a statistically significant improvement in event-free survival and overall survival. The event-free survival was not reached in the Imfinzi and chemotherapy treatment arm whereas it was 46.1 months in the chemotherapy alone arm. Looking to median overall survival, it was not reached in the investigative combination arm and was also not reached in the chemotherapy alone arm.

Notably, according to the FDA’s website, fda.gov, side effects experienced on the trial were consistent with that of prior Imfinzi and platinum-based chemotherapy experience.

For patients weighing at least 30 kilograms, according to the regulatory agency, the recommended dose of Imfinzi is 1,500 milligram every three weeks in combination with chemotherapy prior surgery. After surgery, patients are to continue receiving 1,500 milligrams of Imfinzi alone every four weeks. For those weighing less than 30 kilograms, the dose is based on body weight.

Treatment should continue until one of the following occurs: the disease progresses to a point where surgery is no longer an option, the cancer returns, side effects become too severe or the patient completes a maximum of eight cycles after surgery.

The FDA has approved the use of Imfinzi (durvalumab) with gemcitabine and cisplatin as a neoadjuvant treatment, followed by adjuvant Imfinzi, for muscle invasive bladder cancer. This approval is based on the phase 3 NIAGARA trial, which showed significant improvements in event-free and overall survival with the combination therapy. The trial involved 1,063 patients undergoing radical cystectomy. The recommended dosing varies based on patient weight, and treatment continues until disease progression, severe side effects, or completion of eight post-surgery cycles.

The FDA approved neoadjuvant Imfinzi, gemcitabine and cisplatin, followed by adjuvant Imfinzi after radical cystectomy in muscle invasive bladder cancer.

Dr. Michael J. Pishvaian

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