FDA Approves First PARP Inhibitor Ruc... - Advanced Prostate...

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FDA Approves First PARP Inhibitor Rucaparib for BRCA-mutated metastatic castration-resistant prostate cancer

Tall_Allen profile image
12 Replies

fda.gov/drugs/fda-grants-ac...

This article explains why the BRCA mutation was mandated (as is prior treatment with an AR-directed therapy and taxane chemotherapy and ongoing chemical or physical castration).

pcnrv.blogspot.com/2019/10/...

About 6% of patients with advanced prostate cancer are born positive for the germline BRCA mutation. Good germline BRCA tests (used by Johns Hopkins) are available for $249. It's possible that metastases may develop this mutation even when there is no germline mutation (called a "somatic" mutation), but to determine that metastases must be biopsied, and tests are much more expensive.

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Tall_Allen
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Gemlin_ profile image
Gemlin_

Has this drug any advantages over the existing Olaparib (Lynparza) drug ? Lynparza is also approved for ATM mutations.

Tall_Allen profile image
Tall_Allen in reply to Gemlin_

Lynparza is not approved in the US for prostate cancer.

Gemlin_ profile image
Gemlin_ in reply to Tall_Allen

You are right (as always).

Clovis is in the lead before AstraZeneca/Merck & Co.

Lynparza was granted Priority Review in the US for patients with HRRm mCRPC in January 2020

Gemlin_ profile image
Gemlin_ in reply to Tall_Allen

Lynparza is now approved in the US for prostate cancer, isn't it?

fda.gov/drugs/drug-approval...

Tall_Allen profile image
Tall_Allen in reply to Gemlin_

As of yesterday.

cceds profile image
cceds

My dad has the PALB2 variant. Just to make sure, it seems Rucaparib may be an option for him? Am I understanding correctly?

Tall_Allen profile image
Tall_Allen in reply to cceds

I really don't know for certain. The FDA press release says BRCA1/2 only, but Triton2 found a good response in the handful of patients who had a PALB2. Ask your oncologist to get pre-authorization from his insurance.

cceds profile image
cceds in reply to Tall_Allen

Good call! Thanks :-)

Gemlin_ profile image
Gemlin_ in reply to cceds

Don't know if this is helpful at all. The 2019 ASCO wrote about Olaparib (Lynparza), maybe rucaparib (RUBRACA) have the same or better results?

Approximately 80% of men with BRCA1/2-mutated prostate cancer responded to olaparib, and even though men in the trial had advanced, heavily pretreated prostate cancer, olaparib delayed progression of the disease in these patients for a median of 8.3 months. About 35% were free of progression for more than 1 year.

Among patients with mutations in the PALB2 gene, 57% responded to olaparib—the next highest response after those with BRCA1 or BRCA2 mutations—and 25% of men with CDK12 mutations experienced a response.

cceds profile image
cceds in reply to Gemlin_

Thank you for the info.

saeed_alexy profile image
saeed_alexy

And can you tell how many month patient can live more overall by this drug ?

and its about 8000 $ for month ??? its to expensive!

Tall_Allen profile image
Tall_Allen

It's a good question. The FDA approved it based on response to the drug, not survival. They are giving it a provisional approval until more data come in. 56% of the eligible men responded for more than 6 months, 25% for more than 12 months.

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