AstraZeneca and marketing partner MSD have gained approval in the European Union for Lynparza in first-line ovarian use.
The approval follows a recommendation by the CHMP for its use as a first-line maintenance treatment for women with the BRCA-mutated advanced ovarian cancer.
The approval is based on the SOLO-1 trial, which showed Lynparza reduced the risk of disease progression or death by 70% versus placebo following response to platinum-based chemotherapy.
The EU green light follows US approval in the same setting, and consolidates Lynparza’s position as the runaway leader among PARP inhibitor treatments, and one of AstraZeneca’s star performers.
The new approval for Lynparza will see this growth continue, with EvaluatePharma projecting annual revenues of $2.2bn by 2024.
Lynparza was approved for use in patients with breast cancer in April 2019, and already has two existing licensed uses in ovarian cancer (advanced disease and maintenance therapy). The approval of Lynparza for first-line use makes the drug a triple threat for use in the treatment of ovarian cancer.
The approval of Lynparza for first line ovarian cancer use adds to AstraZeneca’s growing cancer drugs portfolio. Along with Lynparza, Tagrisso and Imfinizi have helped the company’s global oncology sales rise by 54%.
AstraZeneca and MSD are set to explore the use of the drug in additional trials in ovarian cancer. One of these is the ongoing Phase 3 PAOLA-1 trial, which has been testing the use of Lynparza (in combination with bevacizumab) in first-line use for patients with newly-diagnosed, advanced stage IIIB-IV high grade serous or endometrioid ovarian cancer, regardless of BRCA status.
The next targets for the Lynparza partners are prostate cancer and pancreatic cancer, a tumour type which has so far defied treatment by many other agents, but where Lynparza has succeeded in extending progression-free survival in germline BRCA mutated (gBRCAm) patients.