Sotorasib Dosing Regimen
Patent No. EP4340842 (titled "Sotorasib Dosing Regimen") was filed by Amgen on May 17, 2022. The application was issued on Aug 27, 2025.
Patent Summary
This disclosure provides methods for treating cancers harboring a KRAS G12C mutation in patients with active brain metastases by administering sotorasib (AMG 510), an irreversible small-molecule KRAS G12C inhibitor. Dosage regimens include 240 mg, 480 mg, or 960 mg daily, or 240 mg twice daily. Applicable cancers include non-small cell lung cancer (NSCLC), colorectal, pancreatic, and various other solid tumors. The methods encompass managing drug-drug interactions with acid-reducing agents (PPIs, H2RAs), CYP3A4 inducers/substrates, and P-gp substrates. Clinical management includes monitoring liver biomarkers (AST, ALT, ALP) and adjusting doses based on Grade 2+ liver dysfunction or Grade 3+ nausea/diarrhea. Patients may have previously undergone systemic therapies, including platinum-based chemotherapy or anti-PD-1/PD-L1 immunotherapies, and may present with intracranial lesions exceeding 5 mm.
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Date
Description
EP4340842
- Application Number
- EP22729925A
- Filing Date
- May 17, 2022
- Status
- Granted And Under Opposition
- Jul 25, 2025
- Publication Date
- Aug 27, 2025
- External Links
- Slate, Register , Google Patents