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EU Panel Backs Olaparib Approval for Frontline Maintenance in Ovarian Cancer

Gina Columbus @ginacolumbusonc
Published: Monday, Apr 29, 2019

Dave Fredrickson

Dave Fredrickson

The European Committee for Medicinal Products for Human Use (CHMP) has recommended approval of olaparib (Lynparza) as a frontline maintenance treatment for patients with BRCA-mutant advanced high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response (PR) following first-line platinum-based chemotherapy.1

Regarding safety, the most common adverse events (AEs; ≥20%) were nausea (77%), fatigue (64%), vomiting (40%), anemia (39%) and diarrhea (34%). Moreover, the most common grade ≥3 AEs were anemia (22%) and neutropenia (8%). A total 71% of patients on the olaparib arm remained on the recommended starting dose of 300 mg twice daily, and 88% of olaparib-treated patients continued on therapy without an AE-related discontinuation. Forty-eight percent of patients on the olaparib arm did not experience dose interruption due to an AE.

References

  1. LYNPARZA® (olaparib) Receives Positive EU CHMP Opinion for First-Line Maintenance Treatment in BRCA-Mutated Advanced Ovarian Cancer. Merck. Published April 29, 2019. https://bit.ly/2Pz8QEt. Accessed April 29, 2019.
  2. Moore K, Colombo N, Scambia G, et al. Olaparib maintenance therapy following first-line platinum-based chemotherapy in patients with FIGO stage III–IV ovarian cancer (OC) with a BRCA1/2 mutation (BRCAm): Phase III SOLO1 trial. In: Proceedings from the 2018 ESMO Congress; October 19-23, 2018; Munich, Germany. Abstract LBA7_PR.
  3. Moore K, Colombo N, Scambia G, et al. Maintenance olaparib in patients with newly diagnosed advanced ovarian cancer. N Eng J Med. 2018;379(26):2495-2505. doi: 10.1056/NEJMoa1810858.

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