Sotorasib
Sotorasib (Lumakras) was the first drug to hit KRAS, approved in 2021 after four decades of failure.
CodeBreaK 100 (NSCLC ORR 37%), CodeBreaK 200 (PFS vs docetaxel), CodeBreaK 300 (with panitumumab in colorectal cancer, approved January 2025). Full approval in NSCLC pending confirmatory data.
1.Oral drug is absorbed and reaches the tumour
- Route
- Oral
- Schedule
- 960 mg once daily (240 mg daily is the label-optional lower dose in NSCLC); with panitumumab in colorectal cancer
- Dose modifications
- Hold for grade ≥3 hepatotoxicity; discontinue for ILD
- Monitoring
- LFTs every 3 weeks for 3 months then monthly; respiratory symptoms
Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
- Medicare
- Part D (self-administered)
Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026).
- Commercial insurance
- covered with prior authorisation
Covered for FDA-labelled and NCCN-listed uses, but almost always behind prior authorisation confirming diagnosis, biomarker and line of therapy; dispensed through a specialty pharmacy. KRAS G12C by an approved test.
- Assistance programmes
- Amgen SupportPlus
- Amgen Safety Net Foundation
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
Part D out-of-pocket capped at $2,000 (2025) / $2,100 (2026). Medicare patients cannot use manufacturer co-pay cards; charity funds (PAN, HealthWell, CancerCare) and the Extra Help subsidy are the routes.
Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap). Not medical or financial advice; verify with your plan.
- Appraised for
- KRAS G12C-mutated advanced NSCLC after 1 or more systemic therapies
- Notes
- The CDF period ended after CodeBreaK 200 showed a modest PFS gain; NICE's 2024 reappraisal did not recommend routine commissioning at the price offered. Check the current position.
- Cancer Drugs Fund
- Entered the Cancer Drugs Fund under a managed access agreement; check the current CDF list for whether it has since moved to routine commissioning.
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE TA781 · NHS England Cancer Drugs Fund list · SMC advice: sotorasib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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- Dec 2020DesignationUS
Breakthrough Therapy designation source
- 28 May 2021ApprovalUS
Accelerated approval, KRAS G12C NSCLC after ≥1 therapy: first KRAS inhibitor source
- Dec 2023Complete response letterUS
FDA declines full approval based on CodeBreaK 200; postmarketing dose study required source
- 16 Jan 2025ApprovalUS
KRAS G12C colorectal cancer with panitumumab (CodeBreaK 300) source
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2021 | KRAS G12C NSCLC, previously treated (accelerated) |
| US | 2025 | KRAS G12C colorectal cancer with panitumumab |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Diarrhoea | 42% | — |
| Musculoskeletal pain | 35% | — |
| Nausea | 26% | — |
| Fatigue | 26% | — |
| Hepatotoxicity | 25% | 12% |
| Cough | 20% | — |
| Vomiting | 17% | — |
| Interstitial lung disease | 2.2% | 1.1% |
CodeBreaK 100. Rates read from the US prescribing information. Blank cells mean the figure was not sourced, not that it is zero.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare Part D (oral); commercial plans per formulary, often with prior authorisation | not disclosed | amgensupportplus.com |
| United Kingdom | NICE: recommended via Cancer Drugs Fund for KRAS G12C NSCLC after platinum (TA781); later terminated then re-appraised | not disclosed | — |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
Trials
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Landmark trials in OnCo
Patients with KRAS G12C lung cancer that has progressed after chemo-immunotherapy can take an oral KRAS inhibitor instead of docetaxel and gain a somewhat longer time to progression with fewer severe side effects, but should understand that most tumours become resistant within a year and that survival is not improved. KRAS G12C testing is worthwhile, but first-generation inhibitors are a step rather than a cure; combinations and next-generation inhibitors are the active research fronts.
Patients with metastatic colorectal cancer carrying a KRAS G12C mutation (about 3-4% of cases) who have exhausted standard chemotherapy now have a targeted option that works far better than trifluridine-tipiracil or regorafenib. The higher sotorasib dose is clearly superior, and the EGFR antibody is essential because KRAS inhibition alone barely works in bowel cancer. Responses are still modest and short-lived compared with EGFR or ALK inhibitors in lung cancer.
The dose on the label is often not the best dose for patients; it is the highest one that was tolerable for a few weeks. Project Optimus means new cancer drugs should arrive with evidence on dose, and it gives clinicians licence to consider dose reduction for toxicity. For older drugs, the evidence gap persists.
The most frequently mutated oncogene in cancer stopped being undruggable, and patients with KRAS G12C lung and bowel cancers now have targeted pills. The approach, exploiting a mutation-created chemical handle and an inactive-state pocket, has become a template for other hard targets.
Latest papers
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