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AstraZeneca's Tagrisso, Lynparza Net Adjuvant Approvals in Japan

NEW YORK – AstraZeneca on Thursday said the Japanese Ministry of Health, Labor, and Welfare has approved two adjuvant treatment indications of its precision oncology drugs Tagrisso (osimertinib) and Lynparza (olaparib).

Tagrisso is now approved in Japan as an adjuvant treatment for early-stage non-small cell lung cancer patients whose tumors harbor EGFR mutations, and Lynparza is also available as an adjuvant treatment for high-risk, BRCA1/2-mutated early-stage breast cancer patients.

Japanese regulators decided to approve Tagrisso based on results from the Phase III ADAURA trial, in which the EGFR tyrosine kinase inhibitor led to a statistically significant disease-free survival improvement in patients versus placebo. Regulators in the US, Europe, China, and other regions have also approved the drug in this setting using the same data. AstraZeneca will present data from ADAURA on Tagrisso's overall survival benefit at the upcoming European Society for Medical Oncology Congress in September.

Japan's regulatory body also approved the PARP inhibitor Lynparza, which AstraZeneca markets with Merck for a variety of indications including BRCA1/2-mutated, HER2-negative early-stage breast cancer patients who have a high recurrence risk. Regulators reviewed results from the Phase III OlympiA trial, in which Lynparza improved invasive disease-free survival and overall survival versus placebo.

The US Food and Drug Administration and European Commission have also approved adjuvant Lynparza for this population. The OlympiA results and subsequent regulatory approvals have reignited discussion about whether all patients with early breast cancer should undergo germline genetic testing for BRCA1/2 mutations.

"This [approval in Japan] further reinforces the critical need to conduct BRCA testing at the point of diagnosis so that all eligible patients can be identified," Eliav Barr, senior VP and head of global clinical development and chief medical officer of Merck Research laboratories, said in a statement. The National Comprehensive Cancer Network guidelines now recommend BRCA1/2 testing "to aid in adjuvant treatment decisions with olaparib for high-risk HER2-negative breast cancer."