Lung Cancer Epidemiology in the UK
Each year, more than 43,000 people are diagnosed with lung cancer in the UK.Non-small cell lung cancer (NSCLC) is the most common form, accounting for approximately 80–85% of cases.An estimated 13–14% of NSCLC patients harbor the KRAS G12C mutation, which drives uncontrolled cancer cell growth.
UK Approval Announcement
Mirati Therapeutics recently announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional marketing authorization for KRAZATI (adagrasib).
Approved Indication
Monotherapy for the treatment of adult patients with KRAS G12C-mutated advanced NSCLC whose disease has progressed on or after prior platinum-based chemotherapy and/or anti-PD-1/PD-L1 immunotherapy, or who are intolerant to these treatments.
Product Profile
KRAZATI is a highly selective and potent oral small-molecule KRAS G12C inhibitor.It was previously granted accelerated approval by the U.S. FDA in December 2022 for adult patients with locally advanced or metastatic KRAS G12C-mutated NSCLC who have received at least one prior systemic therapy.
Dosage Form and Dosing
Available as 200 mg tablets
Recommended dose: three tablets twice daily
Clinical Trial Data: KRYSTAL-1
Efficacy was evaluated in the open-label, Phase 1/2, multi-cohort expansion trial KRYSTAL-1, which investigated KRAZATI as monotherapy and in combination with other anticancer therapies in patients with KRAS G12C-mutated advanced solid tumors.
Key Efficacy Results
Objective Response Rate (ORR): 43.0%
Median Duration of Response (DOR): 12.4 months
Median Progression-Free Survival (PFS): 6.9 months
Median Overall Survival (OS): 14.1 months
1-year survival rate: 52.8%
2-year survival rate: 31.3%
Safety Profile
Most Common Adverse Reactions
Low red blood cell count (fatigue, pale skin)
Hyponatremia (headache, fatigue, seizures, coma)
Decreased appetite
Dizziness
Nausea, diarrhea, vomiting
Renal function abnormalities
Fatigue/asthenia
Edema (especially ankles and feet)
Decreased white blood cell count
Elevated lipase and/or amylase
Hypokalemia (weakness, muscle cramps, paresthesia, arrhythmia)
Hypoalbuminemia
