Olaparib Receives FDA Approval for BRCA-mutated Advanced Ovarian Cancer

Officials with the FDA have approved olaparib (Lynparza, AstraZeneca and MSD) for the maintenance treatment of adult patients with BRCA-mutated advanced ovarian cancer, according to a press release.

Patients are eligible for treatment with olaparib if they have deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer with complete or partial response to first-line platinum-based chemotherapy. Additionally, patients should be selected for treatment based on an FDA-approved companion diagnostic, the BRACAnalysisCx test, according to the FDA.

With this approval, olaparib is the first approved poly ADP ribose polymerase inhibitor for this indication, AstraZeneca said in a press release.

The approval was based on the phase 3 SOLO-1 clinical trial that compared the efficacy of olaparib with placebo in patients with BRCAm advanced ovarian, fallopian tube, or primary peritoneal cancer following first-line platinum-based chemotherapy. Patients received olaparib tablets 300 mg orally twice daily or a placebo.

According to the data, treatment with olaparib demonstrated a statistically significant improvement in investigator-assessed progression-free survival (PFS) compared with a placebo. The study showed that olaparib reduced the risk of disease progression or death by 70% in patients with BRCAm advanced ovarian cancer who were in complete or partial response to platinum-based chemotherapy.

The estimated median PFS for patients treated with olaparib was not reached compared with 13.8 months for patients treated with a placebo. Data also showed that 60% of patients receiving olaparib remained progression-free at 3 years compared with 27% of patients receiving a placebo.

“Women with ovarian cancer are often first diagnosed with advanced disease, which is associated with poor outcomes,” Dave Fredrickson, executive vice president, head of the oncology business unit of AstraZeneca, said in a statement. “In SOLO-1, olaparib in the first-line maintenance setting reduced the risk of disease progression or death by 70% for patients with BRCAm advanced ovarian cancer. Today’s approval is a critical advancement and brings us closer to our goal of helping these patients achieve long-term remission.”

The recommended dose is 300 mg (two 150-mg tablets) taken orally twice daily, with or without food, for a total daily dose of 600 mg.

The most commonly reported adverse effects in the trial were nausea, fatigue, abdominal pain, vomiting, anemia, diarrhea, upper respiratory tract infection/influenza/nasopharyngitis/bronchitis, constipation, dysgeusia, decrease appetite, dizziness, neutropenia, dyspepsia, urinary tract infection, leukopenia, thrombocytopenia, and stomatitis.

Olaparib is also being evaluated in combination with bevacizumab as a maintenance treatment for patients with newly-diagnosed ovarian cancer, regardless of BRCA status.

References

Lynparza approved by US FDA for 1^st-line maintenance therapy in BRCA-mutated advanced ovarian cancer [news release]. AstraZeneca’s website. https://bit.ly/2PS1wSH. Accessed December 19, 2018.

FDA approves olaparib for first-line maintenance of BRCA-mutated advanced ovarian cancer [news release]. FDA’s website. https://bit.ly/2UX0Or6. Accessed December 19, 2018.