Will AstraZeneca’s targeted therapy Tagrisso (ingredient: osimertinib) solidify its presence as the first-line treatment for lung cancer?

AstraZeneca Korea held a news conference on winning approval for the drug as the first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) mutations.

Ahn Myung-ju, a professor at the Hematology & Oncology Department of Samsung Medical Center, speaks during AstraZeneca Korea's news conference at the Press Center in Seoul, Wednesday.

At the conference, the company presented the critical results of the clinical trial, which led to the expansion of the indication, Tagrisso’s development process, and its clinical value.

As of Dec. 26, the drugmaker obtained Tagrisso’s additional indication for NSCLC patients whose tumors have EGFR mutations, with exon 19 deletions or exon 21 (L858R) mutations.

The regulatory nod enables the use of Tagrisso in the first-line treatment of NSCLC only with the confirmation of EGFR mutations, regardless of T790M mutation, in Korea, too.

Ahn Myung-ju, a professor at the Hematology & Oncology Department of Samsung Medical Center, expressed positive opinions on the use of Tagrisso, while there are other first-line therapies for NSCLC such as Iressa in Korea.

“Patients treated with Tagrisso as the first-line therapy showed a longer survival time. Although prescriptions of Tagrisso are limited because it is not covered by insurance, I think we should use a better drug first,” Ahn said.

AstraZeneca’s Global Medical Affairs Leader Darren Cross said, “Since the development of EGFR-TKI, the treatment environment for NSCLC has improved significantly, but there is still an unmet medical need.”

To address this, the company developed Tagrisso to target both the EGFR-sensitive mutation and the T790M-resistant mutation and to increase the rate of brain barrier passage, he added.

As a third-generation EGFR tyrosine kinase inhibitor (TKI), Tagrisso is an alternative to the first- and second-generation EGFR TKIs such as Iressa and Tarceva. If patients develop resistance to Tagrisso, the follow-up treatment will not be easy.

As for the issue, Ahn said Tagrisso-resistant patients received combination therapies, including chemotherapy. She also noted that Tagrisso resistance mutation was not new and that researchers were studying a related mechanism.

The U.S. Food and Drug Administration approved Tagrisso in April 2018, and the European Commission, in June 2018, as the first-line treatment for metastatic EGFR-mutated NSCLC and locally advanced or metastatic NSCLC.

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