FDA Approves New Indication, Formulation for Lynparza

The FDA has also approved a tablet formulation of Lynparza
The FDA has also approved a tablet formulation of Lynparza

The Food and Drug Administration (FDA) has approved Lynparza (olaparib; AstraZeneca), a poly (ADP-ribose) polymerase (PARP) inhibitor, for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy. In addition, the indication for the treatment of deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer in adult patients who have been treated with three or more prior lines of chemotherapy has been changed from accelerated approval to full approval.

The approvals were based on two, placebo-controlled trials (SOLO-2, Study 19) in patients with recurrent ovarian cancers who were in response to platinum-based therapy. In SOLO-2, 295 patients with recurrent germline BRCA-mutated ovarian, fallopian tube, or primary peritoneal cancer were randomized to receive olaparib or placebo. A statistically significant improvement in investigator-assessed progression-free survival (PFS) was seen in the olaparib group compared with placebo (hazard ratio [HR] 0.30 [95% CI: 0.22, 0.41; P<0.0001]). The estimated median PFS was 19.1 months with olaparib vs. 5.5 months with placebo.

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In Study 19, 265 patients regardless of BRCA status were randomized to receive either olaparib or placebo. A statistically significant improvement in investigator-assessed PFS was seen in those treated with olaparib vs. placebo (HR 0.35 [95% CI: 0.25, 0.49; P<0.0001]). The estimated median PFS was 8.4 months with olaparib vs. 4.8 months with placebo. Moreover, patients treated with olaparib as a maintenance therapy had a median overall survival of 29.8 months compared to 27.8 months for placebo (HR 0.73 [95% CI, 0.55, 0.95]).

The FDA has also approved a tablet formulation of Lynparza in addition to the capsules that were approved in 2014. The tablets are available in 100mg and 150mg strengths. To avoid substitution errors and overdose, Lynparza tablets should not be substituted for the capsules on a milligram-to-milligram basis due to differences in the dosing and bioavailability of each formulation.

For more information visit AstraZeneca.com.