AstraZeneca and its marketing partner MSD are close to gaining an European Union approval for Lynparza in first line use of ovarian cancer.
Lynparza (olaparib) has been given a positive recommendation by the CHMP, which says the drug should be used as a first line maintenance treatment of BRCA-mutated advanced ovarian cancer.
The recommendation is based on the SOLO-1 trial in first-line BRCA-mutant ovarian cancer, with similar approvals expected soon in Japan and China, with US approval already secured.
If approved, it will add to the drug’s recent approval for its use in breast cancer in Europe, another first in the PARP inhibitor class, which also includes GSK/Tesaro’s Zejula and Clovis’ Rubraca.
It will also help Lynparza maintain its growth, with EvaluatePharma forecasting it will hit annual revenues of $2.2bn by 2024.
Lynparza’s sales nearly doubled in Q1 to $237m, with more than half of these sales in the US, and Europe contributing $65m.
The drug has also become the first PARP inhibitor launched in China, and it earned $26m to the firm’s fast-growing emerging markets business unit in Q1.
The positive opinion is for the use of Lynparza tablets as a maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.
AstraZeneca’s Dave Fredrickson
Dave Fredrickson, executive vice president of Oncology at AstraZenecca said: “There remains a significant unmet need in the treatment of advanced ovarian cancer as 70% of women globally relapse within the first three years after their initial treatment. The results of SOLO-1 demonstrate the potential of using Lynparza earlier in the treatment pathway as a maintenance therapy, and reinforce the importance of identifying a patient’s BRCA mutation status as soon as they are diagnosed.”
There is plenty more in the pipeline for Lynparza. Recent positive phase 3 data on pancreatic cancer – a tumour type which has proven a stumbling block for many drugs – is encouraging, and a submission to regulators is expected in the second half of this year.
Phase 3 data readouts in prostate and in first-line all-comers ovarian cancer are also expected soon. If these gain approval, these will add further to Lynparza’s growth trajectory.
As with other ‘personalised medicine’ drugs, the company’s commercial division is aiming to maximise uptake by broadening access to companion diagnostics which can identify BRCA mutations in patients across these tumour types, with AZ also investigating the role of related gene mutations in these diseases.