The FDA recently granted Breakthrough Therapy Designation to osimertinib for adjuvant treatment of early-stage EGFR mutated NSCLC in patients who undergo complete tumor resection, according to a press release. 

Osimertinib is an oral, EGFR-targeted tyrosine kinase inhibitor. 

The therapy is currently approved for “1st-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.” 

Breakthrough Therapy Designation is granted to drugs that are “intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint,” according to the FDA. 

This process is designed to expedite development and potential approval. 

According to the release, about 50% of patients diagnosed in Stage IB and over 75% of patients diagnosed in Stage IIIA experience cancer recurrence within 5 years of surgery. 

The new designation was based on data from the Phase III ADAURA trial, which showed “a statistically significant and clinically meaningful improvement in disease-free survival,” in patients with early-stage EGFR mutated NSCLC. 


By MD /alert Staff