AstraZeneca Tagrisso recommended for approval in EU by CHMP for patients with unresectable EGFR mutated lung cancer

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on the results from the LAURA Phase III trial, which were published in The New England Journal of Medicine.

Results showed Tagrisso reduced the risk of disease progression or death by 84% compared to placebo (hazard ratio [HR] 0.16; 95% confidence interval [CI] 0.10-0.24; p<0.001) as assessed by blinded independent central review. Median progression-free survival (PFS) was 39.1 months in patients treated with Tagrisso versus 5.6 months for placebo.

Overall survival (OS) results remain immature at this current analysis. The trial continues to assess OS as a secondary endpoint.

Each year in Europe, there are more than 450,000 people diagnosed with lung cancer. Among those with NSCLC, the most common form of lung cancer, about 10-15% of patients in Europe have tumours with an EGFR mutation. Additionally, nearly one in five people with NSCLC has an unresectable tumour.

Manuel Cobo, MD, Specialist Physician of the Medical Oncology Service at the Carlos Haya University Hospital, Malaga, Spain, and investigator for the trial, said, “The LAURA results build on the established efficacy of osimertinib and support the approval of the first targeted therapy for patients with unresectable, EGFR-mutated lung cancer. The positive recommendation marks an important step towards offering patients in Europe a targeted treatment option that can extend the time before their disease progresses by more than three years.”

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said, “The news reinforces Tagrisso as the backbone therapy in EGFR-mutated non-small cell lung cancer, meeting the critical unmet need for an effective targeted treatment option in the unresectable setting. Tagrisso has now demonstrated its benefit across all stages of EGFR-mutated lung cancer, representing a pivotal step in transforming care for patients who are urgently in need of innovative therapies that can help extend their lives.”

The safety and tolerability of Tagrisso in the LAURA trial was consistent with its established profile and no new safety concerns were identified.

Tagrisso following CRT was recently approved for the treatment of adult patients with unresectable, Stage III EGFRm NSCLC in the US. Regulatory applications are also currently under review in China, Japan and several other countries based on the LAURA trial.

Tagrisso is approved as monotherapy in more than 100 countries including in the US, EU, China and Japan. Approved indications include 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 is also approved in combination with chemotherapy in the US, China and several other countries for 1st-line treatment of patients with locally advanced or metastatic EGFRm NSCLC.