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

[Tall_Allen]

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.

[Gemlin_]

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

[Tall_Allen in reply to Gemlin_]

Lynparza is not approved in the US for prostate cancer.

[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_ 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 in reply to Gemlin_]

As of yesterday.

[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 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 in reply to Tall_Allen]

Good call! Thanks

[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 in reply to Gemlin_]

Thank you for the info.

[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]

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.