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  • AstraZeneca Tagrisso...

AstraZeneca Tagrisso plus chemotherapy approved in EU for EGFR-mutated advanced lung cancer

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-07-08T11:30:15+05:30  |  Updated On 8 July 2024 11:30 AM IST
AstraZeneca Imfinzi recommended for approval in EU for adults with muscle-invasive bladder cancer
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Cambridge: AstraZeneca has announced that Tagrisso (osimertinib) with the addition of pemetrexed and platinum-based chemotherapy has been approved in the European Union (EU) for the 1st-line treatment of adult patients with advanced epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose tumours have exon 19 deletions or exon 21 (L858R) mutations.

The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use and is based on results from the FLAURA2 Phase III trial published in The New England Journal of Medicine.

In the trial, 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 (hazard ratio [HR] 0.62; 95% confidence interval [CI] 0.49-0.79; p<0.0001). Median progression-free survival (PFS) was 25.5 months for patients treated with Tagrisso plus chemotherapy, an 8.8-month improvement versus Tagrisso monotherapy (16.7 months).

PFS results from blinded independent central review (BICR) were consistent with the results by investigator assessment, showing 29.4 months median PFS with Tagrisso plus chemotherapy, a 9.5-month improvement over Tagrisso monotherapy (19.9 months) (HR 0.62; 95% CI 0.48-0.80; nominal p=0.0002).

Results from a prespecified exploratory analysis of patients in the FLAURA2 trial with brain metastases at baseline showed Tagrisso plus chemotherapy reduced the risk of central nervous system (CNS) disease progression or death by 42% compared to Tagrisso monotherapy (HR 0.58; 95% CI 0.33-1.01) as assessed by BICR. 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.

While the overall survival (OS) results remained immature at the second interim analysis (41% maturity), a trend towards an OS benefit was observed with Tagrisso plus chemotherapy versus Tagrisso alone (HR 0.75; 95% CI 0.57-0.97), as presented at the 2024 European Lung Cancer Congress. The trial continues to assess OS as a key secondary endpoint.

David Planchard, MD, PhD, Thoracic Oncologist at Gustave Roussy Institute of Oncology and principal investigator for the trial, said, “ This news marks a significant advance for patients with EGFR-mutated lung cancer in Europe, providing a new 1st-line treatment option with osimertinib now in combination with chemotherapy. The FLAURA2 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.”

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.”

The safety profile of Tagrisso plus chemotherapy was consistent with the established profiles of the individual medicines.

Tagrisso is approved as monotherapy in more than 110 countries including in the US, EU, China and Japan. Approved indications include for 1st-line treatment of patients with locally advanced or metastatic EGFRm NSCLC, locally advanced or metastatic EGFR T790M mutation-positive NSCLC, and adjuvant treatment of early-stage EGFRm NSCLC. Tagrisso with the addition of chemotherapy is also approved in the US, China, Japan and several other countries for the 1st-line treatment of patients with locally advanced or metastatic EGFRm NSCLC. Tagrisso is also currently under review with global regulatory authorities for patients with unresectable, Stage III EGFRm NSCLC based on the LAURA Phase III trial.

Read also: AstraZeneca India to expand Chennai Global Innovation and Technology Centre with Rs 250 crore investment

astrazenecaastrazeneca newstagrissoosimertinibchemotherapylung cancer
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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