Regulatory reviews start in Europe and Japan for AstraZeneca‑HUTCHMED lung‑cancer combo
AstraZeneca and HUTCHMED filed marketing applications for the ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib) combination in Europe and Japan. The EMA validated the marketing‑authorisation application and Japan’s MHLW accepted the new‑drug application. The filings are based on the SAFFRON Phase III trial, which showed a 45% lower chance of disease progression or death versus chemotherapy and longer survival outcomes.
Why it matters
The approvals would allow the companies to market the combo in two major regions, expanding the addressable market for the MET‑targeted therapy. Investors in HUTCHMED (HCM) and AstraZeneca (AZN) could see revenue growth if the drugs receive approval.
Key facts
- 1The EMA validated and accepted the marketing‑authorisation application for the combination in Europe. stocktitan.net
- 2Japan’s Ministry of Health, Labour and Welfare accepted the new‑drug application for the combination. stocktitan.net
- 3The SAFFRON global Phase III trial enrolled 338 patients with MET‑overexpressing or amplified NSCLC. rttnews.com
- 4In the trial, the combination lowered the risk of disease progression or death by 45% compared with doublet platinum‑based chemotherapy. rttnews.com
- 5Median progression‑free survival was 7.6 months for the combination versus 5.4 months for chemotherapy. rttnews.com
- 6Median overall survival was 17.8 months with the combination versus 12.9 months with chemotherapy, a 4.9‑month extension. rttnews.com
Summary written by AlphAI AI Desk from 5 of 5 sources. Not investment advice. Figures are as stated by the linked sources.