EU Approves AstraZeneca’s Non-Small Cell Lung Cancer Drug

The European Union (EU) has  AstraZeneca’s Tagrisso for the treatment of adult patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).

Specifically, Tagrisso is indicated for EGFRm patients whose tumors have exon 19 deletions for exon 21 (L858R) mutations.

EU’s approval was based on positive results from AstraZeneca’s ADAURA Phase 3 clinical trial. In the trial, Tagrisso showed a statistically significant and clinically meaningful improvement in disease-free survival in the primary analysis of patients with Stage II and IIIA EGFRm NSCLC. 

Additionally, adjuvant treatment with Tagrisso reduced the risk of disease recurrence or death by 83 percent in patients with Stage II and IIIA disease and by 80 percent in the overall trial population of patients with Stage IB-IIIA disease.

Notably, consistent DFS results were elicited regardless of prior chemotherapy use and across all prescribed subgroups. 

The safety and tolerability of Tagrisso was consistent with previous trials. 

“In the early stages of lung cancer, where tumour resection is possible but recurrence is far too common, adjuvant Tagrisso has shown an unprecedented disease-free survival benefit for patients with EGFR mutations,” Margarita Majem, MD, PhD, department of medical oncology at Hospital de la Santa Creu I Sant Pau in Spain, said in the announcement. 

“I expect this approval will change clinical practice in the EU, as it heightens the critical importance of EGFR mutation testing across all stages of lung cancer to ensure as many patients as possible can benefit from targeted medicines like Tagrisso,” Majem continued. 

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 split into NSCLC and small cell lung cancer, with between 80 and 85 percent classified as NSCLC.

According to AstraZeneca, about 30 percent of all patients with NDCLC may be diagnosed early enough to have surgery with curative intent. But recurrence is still common. 

Half of patients diagnosed with Stage IB and over three-quarters of patients diagnosed with Stage IIA have seen recurrence within five years. Additionally, over one-third of the world’s lung cancer patients are in China and about 40 percent of patients with NSCLC have tumors with an EGFR mutation.

Currently, Tagrisso is approved to treat early-stage lung cancer in over 50 countries, including the US and China. 

The drug is also approved for first-line treatment of patients with locally advanced or metastatic EGFRm NSCLC and for the treatment of locally advanced or metastatic EGFR T790M mutation-positive NSCLC in China, the US, Japan, the EU, and many other countries.

Additional global regulatory reviews are ongoing as well, AstraZeneca said. 

Dave Fredrickson, executive vice president of oncology business unit at AstraZeneca stated that with this approval, patients in the EU with EGFR-mutated lung cancer have a targeted, biomarket-driven treatment option available in early stages of their disease that can help them live cancer-free for a longer period of time. 

Most recently, FDA approved Amgen’s Lumakras, the first treatment for adult patients with NSCLC whose tumors have a specific type of genetic mutation and who have received at least one prior systemic therapy.

Lumakras was approved specifically for tumors with KRAS G12C, a type of mutation in a group of genes that help regulate cell growth and division, an FDA spokesperson said. This is the first approved targeted therapy for tumors with any type of KRAS mutation. 

KRAS accounts for nearly 25 percent of mutations in NSCLC cancers and KRAS G12C mutations represent about 13 percent of mutations in NSCLC.