Drug Profile

Savolitinib - AstraZeneca/HUTCHMED

Alternative Names: AZD-6094; HMP-504; HMPL-504; Orpathys; Volitinib; Voressa

Latest Information Update: 11 Nov 2025

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At a glance

Originator Hutchison MediPharma
Developer AstraZeneca; Hutchison MediPharma; HUTCHMED; National Cancer Institute (USA); Samsung Medical Center
Class Antineoplastics; Imidazoles; Pyrazines; Pyrazoles; Pyridines; Small molecules; Triazoles
Mechanism of Action Proto-oncogene protein c-met inhibitors

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

No
New Molecular Entity Yes

Marketed Non-small cell lung cancer
Phase III Renal cell carcinoma
Phase II Colorectal cancer; Gastric cancer; Oesophageal cancer; Prostate cancer
No development reported CNS cancer; Solid tumours

31 Oct 2025 AstraZeneca completes enrolment in phase-III SAFFRON trial in Non-small cell lung cancer (Combination therapy, Late-stage disease, Metastatic disease, Second-line therapy or greater) in Spain, the US, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, France, Italy, Japan, Poland, Turkey, the United Kingdom, Singapore, Chile, Philippines, Hong Kong, Bulgaria, Germany, Greece, Israel, South Korea, Malaysia, Netherlands, Russia, Switzerland, Taiwan, Thailand, Vietnam (PO) (EudraCT2021-006374-24) (NCT05261399)
20 Aug 2025 HUTCHMED completes enrolment in a phase-III trial in Non-small cell lung cancer (Combination therapy, Late-stage disease, Metastatic disease, In adults, First-line therapy) in China (PO) (NCT05009836)
30 Jun 2025 Registered for Non-small cell lung cancer (Second-line therapy or greater, Metastatic disease, Combination therapy, Late-stage disease) in China (PO)

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