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No mets but PSA rising on ADT: USA FDA approves new drug Erleada (apalutamide) to delay mets

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Jim Marshall (not a doctor) said ...

In the USA the Food and Drug Administration (FDA) decides which drugs have enough evidence of effectiveness for the company to sell.

In the USA Insurance companies then decide whether to pay for the treatment.

(In Australia the TGA approves, the PBAC decides whether it is worth spending public money on, then the drug goes on the PBS.)

Note this drug is not approved on the basis that it will make you live longer. Its approval is because it delays the appearance of new lots of cancer (mets, or metastases).

As the study carries on, we may learn about its effect on survival sometime in the future.

... end Jim

 

From the FDA press release:

The U.S. Food and Drug Administration today approved Erleada (apalutamide) for the treatment of patients with prostate cancer that has not spread (non-metastatic), but that continues to grow despite treatment with hormone therapy (castration-resistant). This is the first FDA-approved treatment for non-metastatic, castration-resistant prostate cancer. 

 

The following link to the FDA press release may not last forever:

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm596768.htm

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ardee

Note that last week, the FDA also approved abiraterone acetate (Zytiga) + Prednisone for metastatic, castrate sensitive/naive prostate cancer ie. when you are on an LHRH drug and your PSA is still controlled but there is evidence of mets..

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Charles (Chuck) Maack

Apalutamide/Erleada was approve by the FDA for the treatment of patients with nonmetastatic prostate cancer who are at high risk for disease spread because treatment with hormone therapy is not effective and thus their disease is castration resistant.

 

What is so important with this approval is that known metastasis is not a prerequisite for prescribing as are Xtandi/enzalutamide and Zytiga/abiraterone, thus provides patients another medication in their armament to hopefully stave off and prolong the necessity for chemotherapy.   

 

Median Metastasis Free Survival (MFS) in trial, which was the primary endpoint, was 40.5 months in the apalutamide group as compared with 16.2 months in the placebo group. That translated into a 72% reduction in the relative risk for metastasis or death with the new drug.

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Kezza2

I have just withdrawn from the Aragon trial, (Abiraterone plus apelutimide or placebo) as it has failed after 24 months.  PSA began to raise after 20 months and then spiked and broke out into tumors in the lymph glands in my throat, where it had not been before.  Waiting for a PSMA PET scan to see where it is now, and to see if the previous mets in lymph glands in my pelvis and bone mets are still asleep or have resumed activity.  I am now on enzalutimide so here's hoping it will put everything to sleep again.

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pauldhodson

Thanks Jim, do you have any idea if we Aussies will have access to this any time soon?

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