Drug updated on 10/29/2024
| Dosage Form | Capsule (oral; 75 mg) |
| Drug Class | Kinase inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated, in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test
- Indicated in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy
- Indicated in combination with binimetinib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test.
Latest News
Summary
- This summary is based on the review of 13 systematic review(s)/meta-analysis(es). [1-13]
- In patients with BRAF-mutated colorectal cancer (CRC), overall response rates (ORR) for BRAF inhibitor-based regimens were 23%, compared to 2.5% in control regimens in randomized clinical trials (RCTs), with a significant improvement in overall survival (OS).
- No significant difference in Event-Free Survival (EFS) or Overall Survival (OS) was observed between intermittent PEG-asparaginase (eight doses) and continuous PEG-asparaginase (15 doses) in non-high-risk acute lymphoblastic leukemia (ALL) patients, as well as between low-risk standard treatment with additional PEG-asparaginase (six doses) and standard treatment (two doses), with risk ratios (RR) close to 1.
- Rifamycin-SV significantly reduced Time to Last Unformed Stool (TLUS) compared to placebo in all severity groups, with a Hazard Ratio (HR) of 1.0.
- In single-arm trials, ORR was 17% for two-drug regimens and 34% for three-drug regimens in BRAF-mutated CRC. Encorafenib plus cetuximab is recommended for previously treated BRAF V600E-mutant metastatic CRC.
- For metastatic melanoma, the combination of encorafenib and binimetinib showed superior ORR compared to dabrafenib and trametinib and demonstrated high probabilities of better progression-free survival (PFS) across all efficacy endpoints.
- Nivolumab plus ipilimumab (NIVO+IPI) improved overall survival.
- In metastatic melanoma, encorafenib plus binimetinib had fewer serious adverse events (SAEs) compared to vemurafenib plus cobimetinib [OR 0.51, CrI 0.29-0.91] and atezolizumab plus vemurafenib plus cobimetinib [OR 0.41, CrI 0.21-0.82].
- Fewer discontinuations due to adverse events were observed with encorafenib plus binimetinib compared to vemurafenib plus cobimetinib [OR 0.45, CrI 0.21-0.96].
- Dabrafenib had the best acceptability in terms of severe adverse events compared to vemurafenib [RR 0.66, CrI 0.50-0.87] or encorafenib [RR 0.64, CrI 0.43-0.94].
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Braftovi (encorafenib) Prescribing Information. | 2023 | Pfizer Inc., New York, NY |