- The Food and Drug Administration has approved AstraZeneca plc's cancer drug Tagrisso for first-line treatment of non-small cell lung cancer (NSCLC) in patients with a mutation known as EGFR, the British pharma said April 18.
- Approval for the broadened indication is based on results from a Phase 3 study known as FLAURA, which showed Tagrisso extended median progression-free survival by 8.7 months versus the commonly used drugs Tarceva or Iressa.
- Tagrisso is a key drug in AstraZeneca's oncology plans and one the company hopes will cement its position in the lung cancer market.
Oncology is one of AstraZeneca's therapeutic focuses. The drugmaker expects Tagrisso (osimertinib) and other cancer drugs like Lynparza (olaparib) and Imfinzi (durvalumab) to help offset declining revenues from some of its current top-sellers.
Tagrisso is already available in the U.S. for second-line treatment of EGFR-mutated NSCLC in patients who have progressed on tyrosine kinase inhibitor therapy.
The FLAURA study, results from which were unveiled last year, showed Tagrisso lowered the risk of disease worsening or death by 54%.
Another analysis of the study also showed a benefit for Tagrisso in patients with NSCLC and central nervous system metastases, which may make the drug more competitive in the eyes of physicians. Last year, Tagrisso became AstraZeneca's largest-selling oncology drug, earning $955 million.
Even before the FDA's most recent approval, the positive FLAURA data appeared to have convinced some doctors of the drug's benefit.
"Tagrisso also is starting to accelerate on the back of our first-line data, which of course we don't promote, but some physicians, in particular in the U.S., are already starting to adopt in their daily practice," said company CEO Pascal Soriot on an earning call earlier this year, referring to rules preventing drugmakers from marketing drugs for unapproved uses.
Momentum has built elsewhere in the company's cancer portfolio with a U.S. approval late last year for Calquence (acalabrutinib) in mantle cell lymphoma (MCL).
But AstraZeneca faces stiff competition from oncology rivals, particularly in lung cancer where Imfinzi trails other checkpoint inhibitors.