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Olomorasib

Medicine

Extended indication Olomorasib in combination with pembrolizumab for first line treatment of locally advanced or metastatic KRAS G12C-mutant Non-small cell lung cancer in
Registration phase Clinical trials

Product

Active substance Olomorasib
Domain Oncology
Reason of inclusion New medicine (specialité)
Main indication Lung cancer
Extended indication Olomorasib in combination with pembrolizumab for first line treatment of locally advanced or metastatic KRAS G12C-mutant Non-small cell lung cancer in adults and elderly with PD-L1 expression ≥50%
Manufacturer Eli Lilly
Portfolio holder Eli Lilly
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Intermural (MSZ)
Additional remarks Tweede generatie KRAS G12C inhibitor.

Registration

Registration route Centralised (EMA)
ATMP No
Submission date January 2027
Expected Registration February 2028
Registration phase Clinical trials

Therapeutic value

Current treatment options Sotorasib (KRAS-remmer gegeven als tweedelijns behandeling)
Substantiation De studie loopt nog op dit moment.
References NCT05824858; Sunray -01NCT06119581

Expected patient volume per year

Patient volume 147

Market share is generally not included unless otherwise stated.
References 1: NKR2022; 2: KRAS G12C in advanced NSCLC: Prevalence, co-mutations, and testing, Lim et al., 2023; 3: Real-world prevalence of programmed death ligand 1 expression in locally advanced or metastatic non-small-cell lung cancer: The global, multicenter EXPRESS study. Dietel et al, 2019.
Additional remarks In 2022 waren er 2247 patiënten met een stadium III en 5.135 patiënten met een stadium IV nsclc diagnose. (1). 13% van de NSCLC patienten zijn KRAS G12C mutatie-positief (2). 22% van de NSCLC patiënten in Europa hebben een PD-L1 tumor proportion score ≥50% (3).

Expected cost per patient per year

Potential total cost per year

Off label use

Indication extension

Other information