Adagrasib
Adagrasib was the second KRAS G12C inhibitor, with a long half-life and brain penetration, and is approved in lung and colorectal cancer.
KRYSTAL-1 and KRYSTAL-12 (NSCLC), KRYSTAL-1 with cetuximab in colorectal cancer (accelerated 2024). Mirati acquired by BMS (2024).
1.Oral drug is absorbed and reaches the tumour
- Route
- Oral
- Schedule
- 600 mg twice daily; with cetuximab in colorectal cancer
- Dose modifications
- Reduce to 400 mg BID then 600 mg once daily for GI, hepatic, or QTc toxicity
- Monitoring
- LFTs monthly for 3 months; ECG and electrolytes; renal function
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
- BMS Access Support
- Bristol Myers Squibb Patient Assistance 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.
- Notes
- EU-licensed 2024; UK licence and NICE appraisal for KRAS G12C NSCLC not yet researched.
Sources: NICE search: adagrasib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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- Jun 2021DesignationUS
Breakthrough Therapy designation source
- 12 Dec 2022ApprovalUS
Accelerated approval, KRAS G12C NSCLC after ≥1 therapy source
- 21 Jun 2024ApprovalUS
KRAS G12C colorectal cancer with cetuximab (accelerated) source
- Jun 2025ApprovalUS
Full approval in NSCLC (KRYSTAL-12) source
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2022 | KRAS G12C NSCLC (accelerated) |
| US | 2024 | KRAS G12C colorectal cancer with cetuximab |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Diarrhoea | 70% | 0.9% |
| Nausea | 69% | 4.3% |
| Fatigue | 59% | 7% |
| Vomiting | 56% | 0.9% |
| Musculoskeletal pain | 41% | 7% |
| Hepatotoxicity | 37% | 10% |
| Renal impairment | 36% | 6% |
| Dyspnoea | 35% | 10% |
| Oedema | 32% | 0% |
| QT prolongation | 20% | 6% |
KRYSTAL-1 NSCLC. 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 | bmsaccesssupport.com |
| United Kingdom | NICE: appraisal for KRAS G12C NSCLC (2025) | 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
topRecruiting now (live from ClinicalTrials.gov)
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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.
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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