Latest news on adagrasiib: U.S. FDA accelerates approval of adagrasiib combined with cetuximab for the treatment of KRAS G12C mutated colorectal cancer

On June 21, 2024, the U.S. Food and Drug Administration granted accelerated approval to adagrasiib (Krazati) in combination with cetuximab for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC), as determined by the U.S. FDA.

Efficacy was evaluated in KRYSTAL-1, a multicenter, single-arm expansion cohort trial. Eligible patients must have locally advanced or metastatic KRAS G12C mutant CRC and have received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy and, if eligible, a VEGF inhibitor. Patients were treated with adagracil 600 mg twice daily plus cetuximab biweekly (500 mg/m2 every 2 weeks) or weekly (initial dose 400 mg/m2, followed by 250 mg/m2 weekly). Tumor assessments were performed every 6 weeks. Discontinuation of adalacil requires discontinuation of cetuximab, but patients can continue adalacil treatment if cetuximab is discontinued.

The primary efficacy outcome measures were overall response rate (ORR) and duration of response (DOR) as determined by RECIST v1.1 as assessed by blinded independent central review . Among 94 enrolled patients, the ORR was 34% (95% CI: 25%, 45%), all responses were partial, and the median DOR was 5.8 months (95% CI: 4.2, 7.6). Thirty-one percent of responding patients had a DOR of at least 6 months.

The most common adverse reactions (≥20%) are rash, nausea, diarrhea, vomiting, fatigue, musculoskeletal pain, hepatotoxicity, headache, dry skin, abdominal pain, decreased appetite, edema, anemia, cough, dizziness, constipation and peripheral neuropathy.

The recommended dose of adagracil is 600 mg orally twice daily until disease progression or unacceptable toxicity. For cetuximab dosage information, see Cetuximab Prescribing Information.

United StatesThe FDA accelerated approval of adagrasiib combined with cetuximab for the treatment of KRAS G12C mutated colorectal cancer is based on its significant clinical efficacy and safety data. This new therapy provides these patients with more treatment options and hope. Before using the medicine, the patient must consult your attending doctor and use the medicine under the guidance of the doctor.

The first generic drug of adagrasib has recently been launched on the market in Laos. This global innovative action has ignited new hope for patients and families who have no choice but to give up treatment because they cannot afford the high price of the original drug. This generic drug of adagrasibu produced in Laos has successfully challenged the price hegemony of the original drug, reducing the cost of treatment from the original high price of 200,000 yuan per month to only 8,000 to 9,000 yuan per month. For patients who have any questions about adagrasib, it is recommended to seek help from professional overseas medical consulting agencies.