According to the drug makers, the PARP inhibitor has been approved as a maintenance treatment for recurrent, epithelial ovarian, fallopian tube or primary peritoneal adult cancer irrespective of BRCA status in patients who respond to platinum-based chemotherapy.
The regulator has also approved new use of the drug to be taken as two tablets daily against the previous treatment of eight capsules taken daily twice.
Also, Lynparza tablets have been approved for treating patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer who were treated with three or more lines of chemotherapy in the past.
AstraZeneca global medicines development executive vice president and chief medical officer Sean Bohen said: “Today’s approvals validate more than 10 years of dedicated research behind LYNPARZA, the world’s first PARP inhibitor, which now provides oncologists with the greater flexibility for use in terms of treatment settings.
“It builds on our recently-announced collaboration with Merck, which aims to further increase the number of treatment options available to patients.”
The new approvals from the FDA along with the conversion of accelerated approval to full approval were supported by two randomized trials, said the drug makers.
A phase 3 trial dubbed as SOLO-2 proved the benefit of Lynparza in germline BRCA-mutated (gBRCAm) patients by recording a 70% reduced risk of disease progression or death. It also showed that the PARP inhibitor had improved progression-free survival (PFS) to 19.1 months compared to 5.5 months PFS of placebo.
In a phase 2 trial named as Study 19, the drug was shown to bring down the risk of disease progression or death by 65% while improving PFS to 8.4 months. In addition to that, patients in whom Lynparza was given as maintenance treatment had a median overall survival of 29.8 months which was more than what was recorded in the placebo arm.