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New treatment for advanced prostate cancer put on FDA fast track

Posted at 5:54 PM, Jun 24, 2024

(WXYZ) — In today's health alert, the second leading cause of cancer-related deaths among men worldwide may soon have a promising new treatment. Biontech has announced that their new antibody-drug conjugate candidate aimed at treating advanced prostate cancer has received the FDA fast-track designation.

Most men diagnosed with prostate cancer do not die from it. Detecting it early greatly improves the outcome. However, if the cancer spreads beyond the prostate, survival rates drop sharply. Initially, hormone therapy works well for many with metastatic prostate cancer.

But within 18 to 24 months, a more advanced form, called castration-resistant prostate cancer or CRPC, develops in many patients. This means the cancer is continuing to grow despite hormone therapy, such as lowering testosterone levels, known as castration. Metastatic CRPC has few treatment options, and sadly, the 5-year survival rate is only about 36%.

And this is where BioNTech’s new antibody-drug conjugate candidate comes in. It’s called BNT324/DB-1311. This treatment is aimed at patients with advanced, inoperable, or metastatic CRPC who have worsened despite receiving standard treatments. The antibody-drug conjugate targets a protein called B7-H3, which is found in high levels in various types of tumors. High levels of this protein are associated with cancer progression and poorer outcomes for patients.

Now, early results from the Phase 1/2 trial showed that this treatment was effective against advanced solid tumors, demonstrating antitumor activity. It also had manageable side effects.

Early detection of prostate cancer is crucial for better treatment outcomes. Here’s what to watch out for:

  • Difficulty urinating
  • A weak urine stream
  • Blood in the urine or semen
  • Erectile dysfunction
  • Pelvic discomfort or pain

However, men may not experience symptoms in the early stages. That’s why screening is so important. Men should discuss with their doctor when to start, especially if they are over 50, have a family history of prostate cancer, or are of African American descent. Screening options include:
A prostate-specific antigen test, also called a PSA blood test. It measures the PSA protein made by the prostate gland, and elevated numbers can indicate prostate issues, including cancer.

There is also a Digital Rectal Exam - this is when a healthcare provider checks for prostate abnormalities using a gloved finger in the rectum.

Regular check-ups are key to catching prostate cancer early and managing it effectively.

Wrapping up, I’m all for the FDA’s Fast Track designation for BioNTech’s new antibody-drug conjugate candidate. This could speed up the development process and regulatory review, potentially getting it to patients who need it sooner.