Drug updated on 11/4/2024
Dosage Form | Injection (intravenous; 100 mg/5 mL, 400 mg/20 mL [20 mg/mL] in a single-dose vial) |
Drug Class | Epidermal growth factor receptor (EGFR) antagonists |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use) metastatic colorectal cancer (mCRC): in combination with FOLFOX for first-line treatment
- Indicated as monotherapy following disease progression after prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan-containing chemotherapy.
Latest News
Summary
- This summary is based on the review of seven systematic review(s)/meta-analysis(es). [1-7]
- The FOLFOXIRI regimen combined with panitumumab or cetuximab in metastatic colorectal cancer (mCRC) showed a pooled Objective Response Rate (ORR) of 85% (95% CI (confidence interval), 0.78-0.91) and an R0 resection rate of 42% (95% CI, 0.32-0.53), with median Progression-Free Survival (PFS) ranging from 9.5 to 15.5 months and median Overall Survival (OS) from 24.7 to 37 months.
- Another meta-analysis on mCRC reported a pooled ORR of 82% (95% CI, 76-88%), a pooled R0 resection rate of 59% (95% CI, 49-68%), with PFS ranging from 9.5 to 17.8 months and OS from 24.7 to 62.5 months.
- Panitumumab increased the objective response rate for wild-type (WT) KRAS (RR = 1.70; 95% CI, 1.07-2.69) without a significant effect on mutant KRAS (RR = 0.92; 95% CI, 0.79-1.08); it had no significant impact on mortality overall (RR = 0.86; 95% CI, 0.69-1.08) or specifically in WT KRAS (RR = 0.94; 95% CI, 0.84-1.05).
- Common Adverse Events: Grades 3 and 4 adverse events included diarrhea (29%), neutropenia (28%), and skin toxicity (17%) in mCRC populations. Serious adverse events showed elevated risks for thromboembolism (RR 3.65), skin toxicity (RR 15.22), mucositis (RR 3.18), hypomagnesemia (RR 20.10), and dehydration (RR 2.81).
- Panitumumab Supplementation: An increase in grade 3 and 4 adverse events was observed in the panitumumab group (RR = 1.17), with no significantly increased risk of fatal adverse events (FAEs) compared to placebo or blank treatment.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Vectibix (panitumumab) Prescribing Information. | 2021 | Amgen Inc., Thousand Oaks, CA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
The five-year KRAS, NRAS and BRAF analysis results and treatment patterns in daily clinical practice in Slovenia in 1st line treatment of metastatic colorectal (mCRC) patients with RAS wild-type tumour (wtRAS) – a real-life data report 2013-2018. | 2023 | Radiology and Oncology |
Tumor biomarker testing for metastatic colorectal cancer: a Canadian consensus practice guideline. | 2022 | Therapeutic Advances in Medical Oncology |