AstraZeneca’s Lung Cancer Drug Receives Regulatory Approval In China

Tagrisso, a small molecule inhibitor drug, has been approved in China as a first-line treatment for patients with non-small cell lung tumors bearing specific mutations.

AsianScientist (Sep. 26, 2019) – China’s National Medical Products Administration has granted AstraZeneca marketing authorization for Tagrisso (osimertinib) as a first-line treatment for adults with locally-advanced or metastatic non-small cell lung cancer (NSCLC).

Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-fifth of all cancer deaths; more than breast, prostate and colorectal cancers combined. Lung cancer is broadly split into NSCLC and small cell lung cancer (SCLC), with 80-85 percent classified as NSCLC.

Approximately 10-15 percent of NSCLC patients in the US and Europe, and 30-40 percent of patients in Asia have epidermal growth factor receptor-mutated NSCLC. These patients are particularly sensitive to treatment with inhibitor drugs—called tyrosine kinase inhibitors—that block the cell-signaling pathways that drive the growth of tumors.

Tagrisso belongs to a similar class of inhibitor drugs, but specifically targets tumors bearing exon 19 deletions or exon 21 (L858R) substitutions. The approval of Tagrisso for the treatment of adults with locally-advanced or metastatic NSCLC is based on results from the Phase III FLAURA trial, which were published in The New England Journal of Medicine.

In the FLAURA trial, first-line use of Tagrisso provided a statistically-significant and clinically- meaningful improvement in progression-free survival, increasing the time patients lived without disease progression or death by a median of 18.9 months, versus 10.2 months for those taking standard EGFR tyrosine kinase inhibitor (TKI) medicines. This benefit was consistent across all patient subgroups including those with central nervous system (CNS) metastases.

Safety data for Tagrisso in the FLAURA trial were in line with those observed in prior clinical trials. Tagrisso was generally well tolerated, with Grade 3 or higher adverse events occurring in 34 percent of patients taking Tagrisso, versus 45 percent in the comparator arm. The most common adverse events in patients treated with Tagrisso were diarrhoea (58 percent), rash (58 percent), dry skin (36 percent), nail toxicity (35 percent), stomatitis (29 percent), fatigue (21 percent) and decreased appetite (20 percent).

The article can be found at: Soria et al. (2018) Osimertinib in Untreated EGFR-Mutated Advanced Non–Small-Cell Lung Cancer.


Source: AstraZeneca; Photo: Pixabay.
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