publication date: Jan. 4, 2019

Drugs & Targets

Lynparza gets FDA approval for first-line maintenance in BRCA-mutated advanced ovarian cancer

AstraZeneca and Merck said FDA has approved Lynparza for use as maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy.

Patients with gBRCAm advanced epithelial ovarian, fallopian tube or primary peritoneal cancer are selected for therapy based on an FDA-approved companion diagnostic for Lynparza.

This is the first regulatory approval for a PARP inhibitor in the first-line maintenance setting for BRCAm advanced ovarian cancer.

The approval was based on positive results from the pivotal phase III SOLO-1 trial in which LYNPARZA reduced the risk of disease progression or death by 70 percent in patients with BRCAm advanced ovarian cancer who were in complete or partial response to platinum-based chemotherapy (HR=0.30 [95% CI, 0.23-0.41]; p<0.0001) compared to placebo.

“In SOLO-1, Lynparza in the first-line maintenance setting reduced the risk of disease progression or death by 70 percent for patients with BRCAm advanced ovarian cancer,” Dave Fredrickson, executive vice president, head of the oncology business unit, AstraZeneca, said in a statement.

In the SOLO-1 trial, with median 41 months of follow-up, the median progression-free survival (PFS) for patients treated with LYNPARZA (n=260) was not reached compared to 13.8 months for patients treated with placebo (n=131). In the trial, 60 percent of patients receiving LYNPARZA remained progression-free at three years, compared to 27 percent of patients receiving placebo. The data from the SOLO-1 trial can be found in the Oct. 21, 2018, online issue of the New … Continue reading Lynparza gets FDA approval for first-line maintenance in BRCA-mutated advanced ovarian cancer

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Copyright (c) 2018 The Cancer Letter Inc.