AstraZeneca PLC’s (LONP:AZN) Lynparza drug has been recommended for approval in the EU as a first-line maintenance treatment for women with advanced ovarian cancer.
The Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion of the drug, meaning it will recommend that the European Medicines Agency approve it.
The recommendation is for the use of Lynparza tablets in adult women with advanced ovarian cancer who have responded to an initial round of chemotherapy.
Regulators based their opinion on data from the SOLO-1 trial, which showed the pills reduced the risk of disease progression or death by 70% compared to placebo following response to chemo.
Of those patients receiving Lynparza, 60% of women remained progression-free after three years versus 27% in the placebo arm.
“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,” said Astra’s oncology boss Dave Fredrickson.
“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.”
Chief medical officer Roy Baynes added: “If approved, this expanded indication could change the way women in Europe with BRCA-mutated advanced ovarian cancer are treated.”
In a note to clients, analysts at Shore Capital commented: "Our analysis suggests that consensus estimates for Collaboration Revenue to 2024F are covered by potential milestones from the Merck-Lynparza collaboration alone, although AstraZeneca has several agreements which can also contribute to this revenue line. Hence, we are comfortable with consensus estimates for Collaboration Revenue."
Astra shares were 1.1% to 5,857p in afternoon trade on Monday.
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