AstraZeneca’s Tagrisso Lung Cancer Treatment Wins FDA Approval; Street Says Buy

AstraZeneca announced that it has received US regulatory approval for its Tagrisso treatment used for patients with non-small-cell lung carcinomas with specific mutations.

Specifically, AstraZeneca’s (AZN) osimertinib, sold under the brand name Tagrisso, is a medication used to treat adult patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after tumor resection with curative intent.

The approval was granted as part of the US Food and Drug Administration’s (FDA) Real-Time Oncology Review (RTOR) pilot program. It was based on results from a Phase 3 trial, which showed that the use of Tagrisso reduced the risk of disease recurrence or death by 80%.

“Adjuvant Tagrisso has demonstrated an unprecedented disease-free survival benefit for early-stage lung cancer patients with EGFR mutations who face high rates of recurrence even after successful surgery and subsequent chemotherapy,” said Roy S. Herbst, principal investigator of the Phase 3 trial. “This approval reinforces how critical it is to test all lung cancer patients for EGFR mutations before deciding how to treat them and regardless of their stage at diagnosis.”

On Nov. 30, Cowen analyst Steve Scala reiterated a Buy rating on AZN stock with a price target of $66 (31% upside potential), and recommended the stock as a Best Pharma Idea for 2021.

“AZN has more important news events in 2021 than most other pharma stocks. This includes: Enhertu Ph III data in HER2-low BC, Farxiga Ph III data in HFpEF, Lynparza Ph III data in adjuvant BC, anifrolumab, roxadustat and COVID-19 vaccine approvals/rollouts, tezepelumab full Ph III data/filings in severe asthma, and Tagrisso approval in adjuvant NSCLC, among others,” Scala wrote in a note to investors. (See AZN stock analysis on TipRanks)

From the rest of the Street, the stock scores a Strong Buy analyst consensus based on 6 Buys, and 1 Hold. The average price target of $65.33 implies upside potential of 30% to current levels.