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The drug displayed improvement in progression-free survival and increased the time patients lived without disease progression or death by a median of 18.9 months.
AstraZeneca announced on Sept. 4, 2019 that its drug, Tagrisso (osimertinib), a first-line treatment for adults with locally advanced or metastatic non-small cell lung cancer whose tumors have the genetic mutations of epidermal growth factor receptor (EGFR)exon 19 deletions or exon 21 (L858R) substitutions, received marketing authorization from China’s National Medical Products Administration (NMPA).
The approval comes after the drug tested positively in a Phase III trial. According to a company press release, Tagrisso displayed improvement in progression-free survival and increased the time patients lived without disease progression or death by a median of 18.9 months. This result was shown in all patient subgroups including those with central nervous system metastases.
“The [Phase III] trial has demonstrated the potential of Tagrisso as a new standard of care and as an important new [first-line] treatment option for non-small cell lung cancer patients in China, where approximately 30–40% are diagnosed with an EGFR mutation-more than any other country in the world,” said Dave Fredrickson, executive vice president, oncology, AstraZeneca, in the press release.