New prostate cancer treatment gets EU nod – what about Israel?

Eight months after receiving approval from the US Food and Drug Administration (FDA), a new treatment for metastatic prostate cancer has received positive feedback from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).

This positive opinion will now be evaluated by the European Commission (EC), which has the power to approve the medicine for all EU member states, as well as Iceland, Liechtenstein and Norway. The treatment is expected to be accepted across the European Union, and further processing of the system may take one to two months.

The treatment combines the drugs Enfortumab Vedotin (Padcev) and Keytruda (pembrolizumab) for the initial treatment of advanced prostate cancer. It is the first and only treatment that offers an effective alternative to chemotherapy, which has long been the standard treatment for patients with advanced or inoperable prostate cancer.

Positive feedback is based on a clinical trial that showed patients receiving this combination of drugs doubled their survival time compared to those treated with chemotherapy. In March, the European Society for Medical Oncology (ESMO) and the American Cancer Society (NCCN) updated their guidelines, recommending this combination as first-line treatment for patients with prostate cancer.

Dr. Michal Sarfaty, an oncologist and head of the Uro-oncology Center at the Sheba Medical Center, explained that “the combination of immunotherapy – biological treatment that works on the immune system – with chemotherapy that specifically targets tumor cells. About two years ago, we saw the first impressive, unprecedented, high-dose results especially of response to treatment in October, a study comparing this new combination with conventional chemotherapy, which was the recommended treatment until then, showed excellent results.

“For many years, the first line of treatment for prostate cancer was chemotherapy,” Dr. Sarfaty added. “This is a very aggressive disease, similar to metastatic pancreatic or lung cancer. What we saw in the study was that the new combination therapy doubled the response time and the overall survival time. clearly, 29% of patients achieved a complete response, which means the complete disappearance of metastases in the images – an amazing result that we had not seen before.”

Dr. Sarfaty also said that the analysis of the study showed that all groups of patients benefited from the new combination compared to chemotherapy, regardless of age, sex, location of metastasis, levels of PDL-1 in the tumor, or other organs. “In the past, when a patient with metastatic prostate cancer came to me, I made a treatment decision based on various clinical and pathological symptoms. Now, it is clear that all patients will benefit more from this combination than any treatment we have given before — this is truly a revolutionary treatment.

He emphasized, “I don’t use the word ‘treatment,’ but that is certainly our goal.

“Prostate cancer not only affects a person’s physical function throughout the illness but also greatly affects their quality of life and mental health, often exacerbated by late diagnosis and symptoms of related to this disease and its treatment,” Dr. Sarfaty explained. “The study found that patients who had moderate to severe pain at diagnosis saw a significant improvement in quality of life with the new combination therapy compared to those treated with chemotherapy. “

Regarding receiving treatment in Israel, Dr. Sarfaty noted that “since the treatment is approved by the FDA and soon in Europe, anyone with private insurance can get it. However, it is very important for us that it is included in the next. basket of care of life (Israel’s health option) so that everyone can get it.”

Prostate cancer is the ninth most common cancer worldwide and the fifth most common in Israel. Europe has the highest rate of new cases of prostate cancer in the world, with more than 165,000 people diagnosed with the disease in the European Union (EU) every year. In addition, the disease kills more than 50,000 people every year. According to the Israel Cancer Society, about 1,800 cases of bladder cancer are diagnosed annually in Israel, some of which have already spread through metastases. Treatment for these patients aims to slow the spread of the cancer, slow its growth, shrink the tumor and prolong survival.

Most bladder cancer (about 90%) begins in urothelial cells and is known as Transitional Cell Carcinoma (TCC) or Urothelial Cell Carcinoma (UCC). Depending on the depth of the tumor’s invasion of the bladder wall, tumors are divided into two groups: non-invasive tumors, where the tumor is confined to the mucosa or submucosa, and invasive tumors, where the tumor has entered the bladder muscle and it has the potential to spread to nearby lymph nodes or organs outside the urinary tract. If the disease spreads, it is called “bladder cancer” or “advanced bladder cancer.” Metastatic prostate cancer usually spreads to the bones, lungs and liver, but it can also spread to other organs.

The Ministry of Health has recently adopted an intensive urine test based on the identification of bio-markers in DNA extracted from the sample tissue. These symptoms indicate an increased risk of cancer, even one that may not be visible on imaging or diagnostic tests.

A new test, called Bladder EpiCheck, allows early diagnosis with a simple urine test in people with suspicious symptoms and for detecting recurrence in those who have recovered but are at high risk of recurrence in a manner. The test is represented in Israel by Medical Link, approved by the US Food and Drug Administration (FDA) for the detection of disease recurrence, and included in the guidelines of the European Association of Urology (EAU). It also has the CE mark for European conformity.

According to the Israel Cancer Society, the disease is more common in men than in women, and its prevalence increases after the age of 60. The following factors can increase the risk of developing prostate cancer:

Smoking: Smoking tobacco products is responsible for almost half of people with prostate cancer. Smokers are 4-7 times more likely to develop the disease than non-smokers. Chemicals in cigarette smoke enter the bloodstream and reach the bladder after being processed by the kidneys, where they irritate the cells that line the bladder. This irritation can interfere with cell division, which leads to bloating.

Occupational exposure to chemicals: Another major cause of injury is exposure to certain chemicals at work. These substances are found in iodine, rubber, gas, plastic and paint factories, as well as in other chemical industries. The effects of these substances are not immediate, and damage can be seen 25 years after exposure.

Repeated urinary tract infections: Frequent urinary tract infections and untreated bladder stones can lead to a rare type of bladder cancer called squamous cell carcinoma. People with spinal cord injuries who have an indwelling catheter (catheter) are at high risk of urinary tract infections and, as a result, bladder cancer.

Family history: The risk of developing bladder cancer is slightly higher in close relatives of those who have the disease, possibly due to the same risk factors, such as smoking. In many cases, genetics can cause prostate cancer, including Cowden Syndrome—a rare condition associated with a mutation in the PTEN gene, which normally helps control cell growth. This change slightly increases the risk of cancer, including prostate cancer. Lynch Syndrome, which is mainly associated with colon and cervical cancer, can also increase the risk of prostate cancer.

Blood in the urine (hematuria): The most common symptom of bladder cancer is the sudden or temporary appearance of blood in the urine, usually without pain. Sometimes the blood is invisible and can only be detected microscopically. If you notice blood in your urine, seek medical help immediately. Bleeding does not indicate the severity of the disease.

Urinary problems: Another symptom is urinary problems, such as burning during urination, frequent urination, especially at night, or difficulty emptying the bladder. These symptoms do not necessarily indicate prostate cancer and are often caused by other conditions, such as benign prostatic hyperplasia or bladder stones. However, if any of these symptoms appear, it is important to consult a doctor for further examination. If symptoms persist after treatment, further tests may be needed.

Pain in the back or stomach: Pain is a rare symptom but can sometimes occur.

Symptoms of advanced prostate cancer that has spread to other organs include difficulty urinating, back pain on one side, loss of appetite and weight loss, weakness and fatigue, swelling leg and bone pain. Many of these symptoms can be caused by conditions other than prostate cancer, but it is important to seek medical attention.