publication date: Jan. 2, 2015

Drugs and Targets

FDA Grants Approvals to Lynparza, Blincyto, Xgeva, Gardasil 9 and Cyramza

 

FDA approved Lynparza (olaparib) capsules as monotherapy for the treatment of patients with deleterious or suspected deleterious germline BRCA mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. FDA also approved a molecular companion diagnostic.

The approval of Lynparza, sponsored by AstraZeneca Pharmaceuticals LP, is based on objective response rate from the international single-arm trial in patients with deleterious or suspected deleterious gBRCAm advanced cancers. The trial enrolled 137 patients with measurable, gBRCAm-associated ovarian cancer treated with three or more prior lines of chemotherapy.

Of the 137 patients, 93 percent had an ECOG performance status of 0 or 1. Deleterious or suspected deleterious gBRCAm status was verified retrospectively in 97 percent (59/61) of the patients for whom blood samples were available. The trial results demonstrated an ORR of 34 percent (95% CI: 26, 42). The median response duration was 7.9 months (95% CI: 5.6, 9.6).

FDA concurrently approved the BRACAnalysis CDx companion diagnostic, for use in conjunction with Lynparza.

BRACAnalysis CDx, developed by Myriad Genetics Inc., represents the first FDA-approved companion diagnostic for use with a PARP inhibitor.

The molecular test identifies deleterious or suspected deleterious mutations in the BRCA1 and BRCA2 genes, using DNA obtained from a blood sample. The test was proven in clinical studies to effectively identify patients with BRCA mutations who would be candidates for Lynparza. The approval follows a multiyear scientific collaboration between Myriad and AstraZeneca in ovarian cancer.

 

FDA granted accelerated approval for Blincyto (blinatumomab) for the treatment of Philadelphia chromosome-negative … Continue reading CCL Dec – FDA Grants Approvals to Lynparza, Blincyto, Xgeva, Gardasil 9 and Cyramza

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