What New Diagnostic Tools and Drugs have Emerged as Interesting in 2024,

Part IV

In our last post of the series about what is new in 2024, now that it is 2025, we will look at what drugs have emerged over the last 12 to 18 months.  I am going to discuss the drugs and keep my personal prejudice out of the discussion to keep from clouding the air.  I will simply say that it is very alarming that in 2024 the FDA is still approving drugs to suppress Testosterone.  I guess when there is money involved old cash cows are hard to push aside! 

It would be nice if men’s health and concerns could at least be considered!  Maybe next year?  As long as big Pharma and money is involved, I seriously doubt if our health is ever considered or on an even keel as profit!  I will climb back off my soap box, which is getting pretty tall!

THE DRUGS

Lutetium LU 177 Vipivotide Tetraxetan (Pluvicto™):  FDA approval for men with Prostate-Specific membrane antigen (PSMA)-positive metastatic castration resistant Prostate cancer already treated with ADT (androgen Depravation therapy) and chemotherapy.  The FDA also agreed that LU 177 vipivotide tetraxetan can also be used with any approved PSMA imaging agent. 

Pluvicto™ is the first FDA-approved targeted radioligand therapy, combining a targeting compound and a radioactive particle, called a radioisotope.  How Pluvicto™ works is when it is administered into the bloodstream, Pluvicto™ attaches to the PSMA-positive cells and by using the energy from the radioisotope, induces cell death or inhibits their ability to replicate.  Pluvicto™ is administered intravenously every 6 weeks for up to 6 treatments. 

Sipuleucel T (Provenge®):  This vaccine works by priming the body’s immune system to kill cancer cells.  It does this by adding a protein to white blood cells.  The protein triggers the patient’s immune system to attack Prostate cancer cells.

The vaccine I administered intravenously in 3 doses about 2 weeks apart.  It does not cure advanced Prostate cancer.  It may help men with advanced Prostate cancer live longer, however. The vaccine can be used in men with low volume metastatic castration resistant Prostate cancer with few or no symptoms and a PSA that is slowly rising. 

Gallium 68 Gozetotide (Locametz®):  This is a complimentary radioactive diagnostic agent to be used with PET scans (Positron Emission Tomography) of PSMA-positive tumors to identify candidates for lutetium LU 177 tetraxetan treatment.  Remember from above that Pluvicto™ can also be used with any FDA approved PSMA imaging agent and is not specifically to be used with Locametz®.

Immune Checkpoint Inhibitors:  A group of drugs that are being studied top treat advanced Prostate cancer.  I am listing 3 of them here and they all have previously been FDA Approved to treat other types of cancer.  Ipilimumab (Yervoy®), nivolumab (Opdivo®) and pembrolizumab (Keytruda®) are FDA approved to treat several cancers including melanoma and lung cancer.  Keytruda® is also FDA Approved to treat Prostate cancer that has progressed despite other treatments.

Poly-ADP Ribose Polymerase (PARP) Inhibitors:  Researchers are looking at mutations of BRCA and other homologous recombination repair (HRR) genes and it has led to new treatment options for men with advanced Prostate cancer.  These PARP Inhibitors include drugs like Olaparib (Lynparaza®) and Rucaparib (Rubraca®).  These drugs already have FDA approval for treating ovarian cancer.  These drugs work by blocking the action of PARP, a protein that helps cancer cells repair damaged DNA.  Since the cells cannot repair themselves, they die.

Olaparib: The FDA approved this drug for men with metastatic castration-resistant Prostrate cancer with HRR gene mutations.  These men’s Prostate cancer has progressed in spite of using drugs like Abiraterone or Enzalutamide.  The FDA also approved 2 tests, Foundation One® CDX and BRCAAnalysis CDx®.  These tests are designed to help select men with advanced Prostate cancer carrying BRCA 1 or 2 alterations for treatment with Olaprib.

Rucaparib:  The FDA granted this drug an accelerated approval for men with metastatic castration-resistant Prostate cancer with harmful BRCA mutation that has already been treated with Androgen Depravation Therapy (ADT) and also taxane chemotherapy.   

Rucaparib works by inhibiting the contraction of isolated vascular smooth muscle, including that from the tumors of cancer patients. It also reduces the migration of some cancer and normal cells in culture.  It was discovered as part of a collaboration between scientists working at the Northern Institute of Cancer Research and Medical School of Newcastle University and Agouron Pharmaceuticals in San Diego, California. It was being developed by Clovis Oncology until it was sold to Pharmaand GmbH (Pharma&) as part of Clovis’s bankruptcy proceedings.

Talazoparib (Talzenna®):  The FDA, in June 2023, approved this PARP Inhibitor as a first line treatment of metastatic castration-resistant Prostate cancer (mCRPC) who also have gene mutations involved in repairing DNA.  The drug is taken with other (ADT) drugs when used for Prostate cancer.  The drug was originally approved to treat breast cancer and the approval was expanded to include Prostate cancer, when as mentioned above, it is used with an ADT drug.

Bone Resorption Inhibitors like denosumab (Xgeva®) and zoledronic Acid (Reclast®) (Zometa®).  This class of drugs can help support bone health. They may be able to help reduce bone fractures and bone pain.  These drugs have to be used in conjunction with an ADT drug.  Studies have shown that these drugs can help survival rates for men with Metastatic Castration- Resistant Prostate cancer.  They can also delay the onset of skeletal-related events (like fractures and pain). 

Note:  A disturbing thing about a lot of these drugs is that they must be used with ADT drugs and that is a concern.  Since it has been proven that testosterone does not fuel Prostate cancer,. why are we still considering ADT “normal”?  That seems barbaric to me?!

We are going to begin our next series next week.  It is going to be based on Testosterone and the truth about this hormone and its relationship with the Prostate.  This one is going to take a lot of research and study so it may take a while to work through.