Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that CHEK1 pathogenic variants status confers therapeutic sensitivity to Olaparib in patients with Prostate Adenocarcinoma.
The U.S. Food and Drug Administration granted approval to olaparib for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Olaparib's product label specifies to select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.
This statement is based on a regulatory approval from the Food and Drug Administration:
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.