Novartis prostate cancer drug receives breakthrough designation from US FDA

Recently, the Swiss drug-maker Novartis has received breakthrough designation from US FDA. It is intended to be used for an experimental advanced treatment for castration-resistant prostate cancer.

What is castration-resistant prostate cancer?

Castration-resistant prostate cancer is that type of cancer that keeps growing, even if the amount of testosterone in the body is lowered. Castration-resistant prostate cancer is not fueled by testosterone to grow, and that is why it is not responding to hormone treatments. It is usually a deadly form of prostate cancer that continues to spread to other parts of the body and causes painful side effects.

Despite androgen depletion therapy (ADT), this form of cancer is progressing and can cause new metastases. That is why scientists have long been struggling with finding means of controlling the disease. There are already many options for the treatment of castration-resistant prostate cancer but FDA has recently approved a new experimental advanced treatment, known as Novartis’Lu-PSMA-617. This is actually a tumor-targeting-radiation therapy that aims at lowering the side effects of advanced prostate cancer.

What has the clinical trial revealed about the new therapy for advanced prostate cancer?

The clinical trial, which was released in June, revealed that the new therapy has positive effects on patients with advanced prostate cancer. Men with a deadly form of prostate cancer survived on average four months longer than patients of standard care. This is the reason why FDA approved the experimental designation. This way, its real potential will be demonstrated and could be considered an alternative to available treatments.

How is Novartis therapy actually working?

The therapy involves the attachment of a radioactive isotope, named lutetium 177, to a small molecule drug. The life span of the isotope is less than 7 days. It attaches to the molecule drug called PSMA 617. This molecule drug binds with an antigen expressed in great amounts by prostate cancer cells.

Its first aim is to kill prostate cancer cells in a targeted manner. If radiation is not targeted, then even healthy cells are being damaged through the therapy. But, this way, healthy tissues are being spared and the life expectancy of men is proportionally growing.

Who is Novartis?

Novartis is a Swiss drugmaker and a global leader in radioligand therapy, with broad commercial experience. Actually, Novartis acquired this therapy three years ago, from Endocyte.

However, its portfolio of radioligand therapies is growing. Recently, a new cancer therapy developed by the same company received approval. It is called Lutathera, a cancer medicine for treating cancer in the gut. These tumours are known as gastroenteropancreatic neuroendocrine tumors (GEP‑NETs). Lutathera is a radiopharmaceutical (a medicine that emits a small amount of radioactivity).

What are some other available medical treatments for castration-resistant prostate cancer?

Castration-resistant prostate cancer has been studied for a long time. Thus, there are various options for patients suffering from castration-resistant prostate cancer. Here are some of the most commonly recommended treatments:

  • Immunotherapy for prostate cancer – Immunotherapy takes advantage of the body’s natural immune system to destroy cancer cells. There are 2 types of immunotherapy approved: cancer vaccines and Immunomodulators. Immunotherapy can have many positive results on patients who have tried other treatments that were unsuccessful.
  • Erleada and Xtandi treatments – In 2018, the FDA released the approval for Erleada, a drug used in the treatment of castration-resistant prostate cancer. After that, FDA approved Xtandi as an alternative. Erleada is given in the form of tablets that can be orally taken. Erleada is blocking the body to produce the hormone called testosterone that can fuel cancer cells. The survival rate of patients is increasing and the growing rate of cancer is decreasing.
  • BRD4- Inhibition – Blocking BRD4 protein has positive results on aggressive tumours, that do not respond to ADT. The PROTAC molecule inhibits the metastatic potential of the tumour. The treatment of castration-resistant prostate cancer with a small amount of PROTAC (MZ1) can reduce significantly its growth rate.

Patients who suffer from advanced prostate cancer need to be under the regular supervision of their healthcare providers. This way, they can benefit from any new treatment released. However, bear in mind that prostate cancer is a disease that can be curable if it is early diagnosed. Do not postpone a medical appointment with an expert urologist!

Dr. David Samadi | Robotic Prostate Surgeon

About is a resource created by Dr. David Samadi in order to raise awareness and get more men to receive prostate cancer treatment. The information is strictly general and you should always discuss with your doctor issues concerning your health.


Be sure to subscribe to the latest news regarding prostate cancer by filling the form below.

ARE YOUAT RISK for prostate cancer?

Accessibility Menu