New use of an older drug Lynparza® (olaparib) approved by the FDA for metastatic castrate resistant men who have damage to their BRCA1/2 genes

[Admin]

Who said I can't cut and paste as well as the next person?

My last post advised that a PARP inhibitor, Rubraca® (rucaparib), had been approved by the FDA for the treatment of men with damaged DNA repair genes.

This post advises that a PARP inhibitor, Lynparza® (olaparib), has been approved by the FDA for the treatment of men with damaged DNA repair genes.

 

Jim Marshall (not a doctor) said ...

In the USA the FDA (Food and Drug Administration) has approved a new use of another PARP inhibitor Lynparza® (olaparib), for the treatment of prostate cancer for men with:

• Metastases (cancer moved away from the prostate);
• Damaged BRCA1 or BRCA2 or ATM genes (genes that repair damage to DNA);

“In metastatic castration-resistant prostate cancer that has progressed on front-line hormonal therapy with abiraterone or enzalutamide, olaparib provides statistically significant and clinically meaningful progression-free survival in patients with metastatic castration-resistant prostate cancer and BRCA1, BRCA2, or ATM genetic alterations,” said lead author Maha H.A. Hussain

Approval of Lynparza is the first step. Insurance companies (in the USA) and the PBAC (in Australia) will have to decide whether to cover the cost (which, of course, depends on the price).

Lynparza is one of a family of drugs called PARP inhibitors.

... end Jim

 

https://www.ascopost.com/issues/november-10-2019-supplement-esmo-highlights/phase-iii-profound-study-evaluates-olaparib-in-setting-of-mcrpc/

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[ardee]

Please note one very important distinction between the approvals. Rubraca (rucaparib) requires prior treatment with chemotherapy; Lynparza (olaparib) does not. This is related to the design of the respective clinical trials.

 

[DiRi]

Hi - is this something that might be prescribed to someone who has been on Xtandi after it begins to fail (ie PSA is rising?) My husband has been on Xtandi for well over a year but his PSA has doubled (is 3 now) over the last 2.5 months.  He has had chemo previously so i'm wondering if would he possibly qualify for this if he had the required gene testing?

[Admin]

The patients on the study that led to this American approval had a lot of men who were heavily treated before they came into the study.

So, if the damaged DNA repair genes are found, it might be a technical possibility.

Australian approval nowdays follows fairly soon after the USA approval.

Putting the drug on the PBS can take a few months longer if the price is right, even longer if the government has to negotiate.

The drug is approved in Australia for other purposes, so you will have to ask your doctor whether he is able to get hold of it, given the current circumstances (not yet approved for prostate cancer).

Good luck with that.

Jim

[DiRi]

Thanks for the info Jim, will have to wait and see.  The oncologist has put hubby back onto full dose of 4 Xtandi daily rather than the 3 that he cut him back to due to side affects.  Will see if that does the job of holding or reducing PSA over the next couple of months, Take care, Di