UK pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN) has received a new indication approval from the US Food and Drug Administration (FDA) for its lung cancer therapy Tagrisso (osimertinib). The fresh indication allows for the use of Tagrisso in combination with chemotherapy for patients with advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC). Previously, Tagrisso was approved as a monotherapy, establishing it as the global first-line standard of care for this indication.
The FDA’s decision was supported by data from the FLAURA2 Phase III study, which demonstrated that the combination of Tagrisso with chemotherapy reduced the risk of disease progression or death by 38% compared to Tagrisso monotherapy (p<0.0001). This combination regimen also achieved an 8.8-month increase in median progression-free survival (PFS), extending the median PFS to 25.5 months for Tagrisso plus chemotherapy versus 16.7 months for Tagrisso monotherapy. While overall survival data was still immature at the time of data analysis, it is anticipated to favor the Tagrisso combination regimen.
In the US, lung cancer impacts over 200,000 individuals per year, with 80%-85% being NSCLC cases, and approximately 15% of NSCLC patients having EGFR-mutated disease. The latest approval for Tagrisso signifies that the combination of Tagrisso and chemotherapy will set a new benchmark, becoming the new first-line standard of care for this group of patients.- Flcube.com
