FDA Grants Breakthrough Therapy Designation to Adjuvant Dabrafenib Plus Trametinib for Melanoma

Share this content:
Dabrafenib plus trametinib is the first adjuvant therapy indicated specifically for melanoma with the BRAFV600 mutation.
Dabrafenib plus trametinib is the first adjuvant therapy indicated specifically for melanoma with the BRAFV600 mutation.

The US Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to combination dabrafenib and trametinib as adjuvant treatment for patients with BRAFV600 mutation–positive stage III melanoma following complete resection.

Dabrafenib plus trametinib previously received BTD for metastatic melanoma, non–small cell lung cancer (NSCLC), and anaplastic thyroid cancer (ATC), though this is the first adjuvant therapy indicated specifically for melanoma with the BRAFV600 mutation.

The FDA granted BTD based on evidence from the phase 3 COMBI-AD study (ClinicalTrials.gov Identifier: NCT1682083), for which researchers randomly assigned 870 patients with stage III melanoma who underwent complete resection to receive dabrafenib plus trametinib or placebo for 1 year.

At the median follow-up of 2.8 years, patients in the treatment arm had a relapse-free survival rate of 58% compared with 39% in the placebo arm (hazard ratio [HR], 0.47; 95% CI, 0.39-0.58; P < .001).

The 3-year overall survival rate was 86% and 77% among patients in the combination-treatment arm and the placebo arm, respectively (HR, 0.57; 95% CI, 0.42-0.79; P = .0006), but this finding did not meet the pre-specified interim analysis boundary of P = .000019.

Ninety-seven percent of patients who received the treatment combination experienced adverse events (AEs); 41% of patients reported grade 3 to 4 AEs and 26% of patients reported an AE that led to treatment discontinuation. The toxicity profile was consistent with previously reported findings for dabrafenib plus trametinib.

Reference

  1. Breakthrough therapy designation for stage III BRAF V600 mutation-positive melanoma patients [news release]. Basel, Switzerland: Novartis; October 23, 2017. https://www.novartis.com/news/media-releases/novartis-combination-adjuvant-therapy-tafinlarr-mekinistr-receives-fda. Accessed October 23, 2017. 

Related Resources

You must be a registered member of Cancer Therapy Advisor to post a comment.

Regimen and Drug Listings

GET FULL LISTINGS OF TREATMENT Regimens and Drug INFORMATION

Bone Cancer Regimens Drugs
Brain Cancer Regimens Drugs
Breast Cancer Regimens Drugs
Endocrine Cancer Regimens Drugs
Gastrointestinal Cancer Regimens Drugs
Gynecologic Cancer Regimens Drugs
Head and Neck Cancer Regimens Drugs
Hematologic Cancer Regimens Drugs
Lung Cancer Regimens Drugs
Other Cancers Regimens
Prostate Cancer Regimens Drugs
Rare Cancers Regimens
Renal Cell Carcinoma Regimens Drugs
Skin Cancer Regimens Drugs
Urologic Cancers Regimens Drugs

Sign Up for Free e-newsletters