AstraZeneca shares soar on US approval for lung cancer drug
The FDA backing covers the treatment of locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).
It was based on the results from the FLAURA2 Phase III trial published in The New England Journal of Medicine. Tagrisso with the addition of chemotherapy was found to reduce the risk of disease progression or death by 38 per cent compared to Tagrisso monotherapy, which is the 1st-line global standard of care.
Each year in the US, over 200,000 people are diagnosed with lung cancer, and 80-85 per cent of these patients are diagnosed with NSCLC, the most common form of the disease.
Dave Fredrickson, Executive Vice-President, Oncology Business Unit, AstraZeneca, said: “This important new treatment option can delay disease progression by nearly nine additional months, establishing a new benchmark with the longest reported progression-free survival benefit in the 1st-line advanced setting.
“This approval reinforces Tagrisso as the backbone of EGFR-mutated lung cancer treatment either as monotherapy or in combination with chemotherapy.
“The news is especially important for those with a poorer prognosis, including patients whose cancer has spread to the brain and those with L858R mutations.”
Laurie Ambrose, President and CEO, GO2 for Lung Cancer, added: “We are so excited to see this continued progress advancing more personalised treatment options for our community. The more we can target the right treatments for the right people at the right time, the better outcomes will be for our community - a goal we all collectively share.”
The US regulatory submission was reviewed under Project Orbis, which provides a framework for concurrent submission and review of oncology medicines among participating international partners.
As part of Project Orbis, Tagrisso in combination with chemotherapy is also under review by regulatory authorities in Australia, Canada and Switzerland. Regulatory applications are also under review in several other countries based on the FLAURA2 results.
Tagrisso is approved as monotherapy in more than 100 countries including in the US, EU, China and Japan.
• AstraZeneca has completed the acquisition of Icosavax, Inc., a US-based clinical-stage biopharma company focused on developing differentiated, high-potential vaccines using an innovative, protein virus-like particle platform.
The deal is expected to stack up to $1.1 billion. Icosavax has become a subsidiary of AstraZeneca with operations in Seattle.
The acquisition will build on AstraZeneca's expertise in respiratory syncytial virus (RSV), strengthening its Vaccines & Immune Therapies late-stage pipeline with Icosavax's lead investigational vaccine candidate, IVX-A12.
IVX-A12 is a potential first-in-class, Phase III-ready, combination protein VLP vaccine which targets both RSV and human metapneumovirus (hMPV), two leading causes of severe respiratory infections and hospitalisations in adults aged 60 and older – plus people with chronic conditions such as cardiovascular, renal and respiratory disease.
