AstraZeneca announced that the FDA has granted Breakthrough Therapy Designation (BTD) for Tagrisso (osimertinib) for the first-line treatment of patients with metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC).

Tagrisso is currently approved in the United States, European Union, Japan and China, as second-line treatment for patients with advanced NSCLC who progress following treatment with an EGFR TKI due to the EGFR T790M resistance mutation.

AstraZeneca’s shares have outperformed the industry year to date. The stock has surged 25.4% compared with the industry’’s gain of 18%.

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The BTD is based on the phase III FLAURA study evaluating Tagrisso versus standard-of-care EGFR tyrosine kinase inhibitor (TKI) therapy in the first-line lung cancer setting. The data showed that treatment with Tagrisso reduced the risk of progression or death by more than half compared with other commonly-used EGFR inhibitors for the first-line treatment of patients with EGFR mutation-positive NSCLC. The median progression-free survival (PFS) was 18.9 months for patients on Tagrisso as compared with 10.2 months in the comparator arm. Tagrisso was well tolerated with a safety profile consistent with previous experience.

BTD from the FDA will expedite the development and review of drugs that are intended to treat serious diseases and should provide access of the drug to patients as soon as possible.

In a separate release the company also announced that European Medicines Agency (EMA) has accepted a Marketing Authorisation Application (MAA) for Imfinzi (durvalumab) for the treatment of patients with locally-advanced (Stage III), unresectable NSCLC whose disease has not progressed following platinum-based chemoradiation therapy. The MAA submission was based on encouraging data from phase III PACIFIC study .

Imfinzi has already received accelerated approval in the United States for the treatment of patients with locally advanced or metastatic urothelial carcinoma, who have disease progression during or following platinum-containing chemotherapy, or whose disease has progressed within 12 months of receiving platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery.

A potential label expansion of the drugs will boost the sales of the company.

In June 2017, another pharmaceutical giant, Roche Holdings RHHBY announced that the global, randomized phase III study, ALEX, on lung cancer drug Alecensa met its primary endpoint as an initial (first-line) treatment. Alecensa significantly reduced the risk of disease worsening or death (progression-free survival, PFS) compared with Pfizer’s PFE Xalkori in patients suffering from anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).