In major victory, AstraZeneca wins FDA approval for potential $3B lung cancer med
- The FDA has approved a second-generation tyrosine kinase inhibitor for second-line treatment of epidermal growth factor receptor (EFGR)-mutated non-small cell lung cancer (NSCLC). The drug, AstraZeneca's Tagrisso, specifically targets the T790M mutation. It received accelerated approval from the regulator, as well as breakthrough and orphan drug designations. Only two and a half years passed from the start of clinical trials to final approval.
- Tagrisso was approved in conjunction with a companion diagnostic test (cobas EGFR Mutation test v2), which specifically tests for the T790M resistance mutation.
- Since all patients eventually develop resistance to first-line EGFR inhibitors, a second-line treatment agent for patients with the T790M mutation is necessary. Roughly 10% to 35% of all patients with NSCLC have an EGFR mutation. Among patients who have never smoked, that mutation is present in 50% of tumors.
AZ committed to achieving $45 billion in sales by 2023—a promise often reiterated as AZ fought off a Pfizer acquisition last year. Different projections estimate that sales of Tagrisso could reach the $1 billion to $3 billion range in 2020, making it an important contributor to AZ's sales forecast.
Approval of Tagrisso was based on the strength of two phase 2 single-group studies, which involved a total of 411 patients. In the two studies, 57% and 61% of patients experienced a complete or partial reduction in tumor size. These are positive results given the challenge of getting responses from patients who have become resistant to first line treatments.
Although Tagrisso is the first second-generation EFGR drug, rociltinib from Clovis Oncology is expected to be approved by the end of March. The survival rates for advanced NSCLC are low—no more than 50% during the first year alone, and down to single digits at the five-year mark. The availability of additional treatment options beyond the first line of treatment should help patient care.