# HUTCHMED and AstraZeneca Win Review Acceptance for Lung Cancer Combination in Europe and Japan > HUTCHMED and AstraZeneca's ORPATHYS plus TAGRISSO filings were accepted for review in Europe and Japan. - Published: 2026-11-02T00:17:17+00:00 - Section: Regulation & Approvals - Author: News Desk - URL: https://newsforagent.com/news/2026-11-02/hutchmed-orpathys-tagrisso-europe-japan-filings - Source: [TradingView](https://www.tradingview.com/news/globenewswire:78e00a923094b:0-hutchmed-announces-regulatory-filings-accepted-for-review-for-orpathys-plus-tagrisso-in-met-driven-egfr-mutated-lung-cancer-in-europe-and-japan/) ## Key takeaways - The European Medicines Agency validated AstraZeneca's Marketing Authorization Application for ORPATHYS plus TAGRISSO, and Japan's MHLW accepted a New Drug Application for the same combination. - The SAFFRON Phase III trial in 338 patients showed ORPATHYS plus TAGRISSO reduced the risk of disease progression or death by 45% versus doublet platinum-based chemotherapy. - The Europe and Japan filings follow a US FDA new drug application for the combination submitted in September 2026. HUTCHMED (China) Limited said regulatory filings for ORPATHYS (savolitinib) plus TAGRISSO (osimertinib) in MET-driven EGFR-mutated lung cancer have been accepted for review in Europe and Japan. The filings follow a US FDA new drug application for the same combination submitted in September 2026, [TradingView](https://www.tradingview.com/news/globenewswire:78e00a923094b:0-hutchmed-announces-regulatory-filings-accepted-for-review-for-orpathys-plus-tagrisso-in-met-driven-egfr-mutated-lung-cancer-in-europe-and-japan/) reported. HUTCHMED is a commercial-stage biopharmaceutical company developing targeted therapies and immunotherapies for cancer and immunological diseases, with its first four medicines marketed in China. ## How the Europe and Japan Filings Were Accepted In Europe, the European Medicines Agency validated and accepted for review the Marketing Authorization Application submitted by [AstraZeneca](https://akta.pro/company-profiles/000026p/astrazeneca). The application seeks approval for the combination in patients with locally advanced or metastatic non-small cell lung cancer whose tumors have MET overexpression or amplification and who progressed on or after EGFR tyrosine kinase inhibitor therapy. In Japan, AstraZeneca submitted a New Drug Application to the Ministry of Health, Labour and Welfare, which was also accepted for review, for patients with unresectable, advanced or recurrent NSCLC with MET overexpression or amplification after EGFR-TKI therapy. The filings rest on results from the SAFFRON global Phase III trial, a randomized, open-label, multi-center study in 338 patients across 230 centers in 29 countries. ORPATHYS plus TAGRISSO reduced the risk of disease progression or death by 45% compared with doublet platinum-based chemotherapy, based on a PFS hazard ratio of 0.55. Median PFS by blinded independent central review was 7.6 months versus 5.4 months, and the combination reduced the risk of death by 32%, extending median overall survival by 4.9 months (17.8 versus 12.9 months). The data were presented at the ESMO Congress 2026 Presidential Symposium and published simultaneously in The New England Journal of Medicine. ORPATHYS is jointly developed by AstraZeneca and HUTCHMED and commercialized by AstraZeneca. ## HUTCHMED's Run-Up to the Dual Filings AstraZeneca submitted the FDA new drug application for ORPATHYS plus TAGRISSO in MET-driven EGFR-mutated lung cancer after EGFR-TKI progression in September 2026, FinancialContent Business Page reported. HUTCHMED said in September 2026 that it would present new clinical data from two Phase III studies at ESMO Congress 2026 in Madrid, including results from the SAFFRON and SANOVO studies, FinancialContent Business Page reported. On October 29, 2026, the FDA granted orphan drug designation to sovleplenib for primary immune thrombocytopenia, making the drug eligible for seven years of US market exclusivity upon approval, Stock Titan reported. ## Regulatory Milestones Elsewhere in the Sector Sino Biopharmaceutical said its TQ-A3334 and TQA3605 obatins received breakthrough therapy designation from the China Drug Evaluation Center on October 27, 2026, [The future of trading](https://capital.com/en-int/news/sino-biopharmaceutical-says-tq-a3334-tqa3605-obatins-breakthrough-therapy-designation) reported. CytoDyn said on October 22, 2026 that it will not apply for accelerated approval in January 2027, [Investorshangout](https://investorshangout.com/post/view?id=6849445) reported. Xtalks will host a webinar on FDA meetings for cell and gene therapy sponsors on November 12, 2026, [PR Newswire](https://www.prnewswire.com/news-releases/fda-meetings-engaging-regulators-throughout-cell-and-gene-therapy-development-upcoming-webinar-hosted-by-xtalks-302923072.html) reported. ## HUTCHMED's November 5 Data Webcast HUTCHMED will co-host a webcast with Citigroup on November 5, 2026, to discuss Phase III savolitinib data in MET-driven non-small cell lung cancer, Stock Titan reported. The event will feature insights from the SANOVO and SAFFRON trials, with Professor Yi-Long Wu and Dr. Weiguo Su on the panel. ## Companies in this story - HUTCHMED (China) Limited · website: https://www.hutch-med.com - [AstraZeneca company profile](https://akta.pro/company-profiles/000026p/astrazeneca) · website: https://www.astrazeneca.com --- News for Agent · https://newsforagent.com/llms.txt