5th Jul 2024 08:36
(Alliance News) - AstraZeneca PLC on Friday announced that its medication osimertinib, alongside chemotherapy, has been approved by the European Commission.
The Cambridge, England-based pharmaceutical company said the drug, brand name Tagrisso, can now be used as a first-line treatment for adults with advanced epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer.
AstraZeneca said the EU approval follows a positive opinion, announced in early June, by the European Commission's Committee for Medicinal Products for Human Use.
The approval is based on results from the Flaura2 phase 3 trial, in which the Tagrisso-chemotherapy combination reduced the risk of disease progression or death by 38%, compared with Tagrisso monotherapy which is the current standard of care.
Median progression-free survival was also improved with the added chemotherapy, AstraZeneca said, rising to 25.5 months compared with 16.7 months for Tagrisso alone.
AstraZeneca also said Tagrisso plus chemotherapy reduced the risk of central nervous system progression or death by 42%.
"With two years of follow up, 74% of patients treated with Tagrisso plus chemotherapy had not experienced CNS disease progression or death versus 54% of patients treated with Tagrisso monotherapy," AstraZeneca added.
However, AstraZeneca did note that overall survival results "remained immature" with 41% maturity - although there was still "a trend towards an OS benefit" for Tagrisso plus chemotherapy.
Tagrisso plus chemotherapy is also approved "in the US, China, Japan and several other countries for the first-line treatment of patients with locally advanced or metastatic EGFRm NSCLC".
"This approval reinforces Tagrisso as the backbone therapy in EGFR-mutated lung cancer either as monotherapy or in combination with chemotherapy," commented Dave Fredrickson, executive vice president of Astra's oncology business unit. "This is especially important for those with more aggressive disease, including patients whose cancer has spread to the brain and those with L858R mutations."
Shares in AstraZeneca rose 0.5% to 12,164.00 in London early on Friday morning.
By Emma Curzon, Alliance News reporter
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