HQ Team
July 5, 2024: The Europen Union has approved AstraZeneca’s Tagrisso along with chemotherapy treatment for lung cancer patients after trials showed an extended nine months of survival.
The approval by the European Commission follows a positive opinion from the Committee for Medicinal Products for Human Use and is based on results from an end-stage trial.
The commission approved the first-in-line treatment for patients with advanced epidermal growth factor receptor-mutated non-small cell lung cancer, according to a statement from AstraZeneca.
The combination therapy extended median progression-free survival by nearly nine months compared to the standard-of-care treatment.
EFR genes
Osimertinib, sold by AstraZeneca under the brand name Tagrisso, is a medication used to treat non-small-cell lung carcinomas with specific mutations.
These patients have certain types of abnormal epidermal growth factor (EGFR) genes.
Tagrisso with the addition of chemotherapy reduced the risk of disease progression or death by 38% by investigator assessment compared to Tagrisso monotherapy, which is the 1st-line global standard of care, according to the statement.
Median progression-free survival was 25.5 months for patients treated with chemotherapy — an 8.8-month improvement versus monotherapy.
Central nervous system
During a blinded independent central review, the chemotherapy combination showed a 9.5-month improvement over monotherapy.
The combination treatment also reduced the risk of central nervous system disease progression or death by 42%.
The overall survival results remained immature at the second interim analysis and the trial continues to assess overall survival rates as a key secondary endpoint, according to the statement.
Survival rates are key indicators for the assessment of standards of therapy. It constitutes the percentage of people in a study or treatment group who are still alive for a certain period after they were diagnosed with or started treatment for a disease, such as cancer.
The trial results “build on the established efficacy of osimertinib monotherapy, showing a meaningful nine-month improvement in progression-free survival and offering physicians the option to tailor treatment to a patient’s specific needs,” said David Planchard, MD, PhD, Thoracic Oncologist at Gustave Roussy Institute of Oncology and principal investigator for the trial.
Brain cancer
Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “This approval reinforces Tagrisso as the backbone therapy in EGFR-mutated lung cancer either as monotherapy or in combination with chemotherapy.
“This is especially important for those with more aggressive disease, including patients whose cancer has spread to the brain and those with L858R mutations.”
Tagrisso is approved as monotherapy in more than 110 countries including the US, EU, China and Japan.
Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-fifth of all cancer deaths.
Lung cancer is broadly split into NSCLC and small-cell lung cancer. Each year there are an estimated 2.4 million people diagnosed with lung cancer globally, with 80-85% of patients diagnosed with NSCLC, the most common form of lung cancer.
