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Lumakras
Published
Product name
Lumakras
Active ingredient
Sotorasib
Submission type
New chemical entity
Decision
Approved for provisional registration
Decision date
Registration date
What this medicine was approved for
Lumakras (sotorasib) was approved for the following therapeutic use:
Lumakras has provisional approval in Australia for the treatment of adult patients with KRASG12C mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior systemic therapy for advanced disease.
The decision to approve this indication has been made on the basis of the objective response rate (ORR) and the duration of response (DOR). Continued approval of this indication depends on the verification and description of benefit in confirmatory trials.
How this medicine works
Sotorasib is a Kirsten rat sarcoma (KRAS)G12C inhibitor, which covalently and irreversibly binds to the unique cysteine of KRASG12C. Inactivation of KRASG12C by sotorasib blocks tumour cell signalling and survival, inhibits cell growth, and promotes apoptosis selectively in tumours harbouring KRASG12C, an oncogenic driver of tumourigenesis across multiple cancer types. The potency and selectivity of sotorasib is enhanced through the unique binding to both the P2 pocket and the histidine 95 (His95) surface groove, locking the protein in an inactive state that prevents downstream signalling without affecting wild-type KRAS.Sotorasib demonstrated in vitro and in vivo inhibition of KRASG12C with minimal detectable off target activity against other cellular proteins and processes. Sotorasib impaired oncogenic signalling and tumour cell survival at clinically relevant exposures in preclinical models expressing KRASG12C. Sotorasib also enhanced antigen presentation and inflammatory cytokine production only in tumour cells with KRASG12C. Sotorasib induced anti tumour inflammatory responses and immunity, driving tumour regressions in immunocompetent mice implanted with KRASG12C expressing tumours.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Lumakras was considered favourable for the therapeutic use approved.
Sponsor