gdc
FDA Approvals, News & UpdatesMelanomaNewsworthy

Braftovi plus Mektovi a New Combination for Metastatic Melanoma with BRAF Mutation

October 2018 Vol 4 No 5

In June 2018, the FDA approved 2 new drugs Braftovi and Mektovi (encorafenib and binimetinib; from Array BioPharma) to be used in combination for the treatment of patients with unresectable (can’t be removed by surgery) or metastatic (spreading) melanoma and a BRAF V600E or V600K mutation. At the same time, the FDA also approved the THxID-BRAF kit, which is a test to identify a BRAF mutation. Patients should have this new genetic test to identify the BRAF mutation before using this new targeted drugs combination.

The FDA approved this new combination based on a clinical trial of 577 patients with unresectable or metastatic melanoma and BRAF V600E or BRAF V600K mutation. The results showed that the average time without disease progression was 14.9 months with the new combination compared with only 7.3 months with another drug, Zelboraf (vemurafenib), which was previously approved for patients with melanoma.

The most common side effects with the new combination were fatigue, nausea, diarrhea, vomiting, abdominal pain, and joint inflammation. A few patients (5%) discontinued treatment with the new drugs because of bleeding and headache.

Share this:

Recommended For You
FDA Approvals, News & UpdatesLymphoma
FDA Approved Breyanzi, Novel Gene Therapy, for Large B-Cell Lymphoma
In February 2021, the FDA approved Breyanzi (lisocabtagene maraleucel; from Juno Therapeutics), a new CAR T-cell therapy, for the treatment of adults with relapsed or refractory large B-cell lymphoma after 2 or more lines of systemic therapy.
FDA Approvals, News & UpdatesFollicular LymphomaLymphoma
FDA Approved Ukoniq, New Targeted Therapy, for Marginal-Zone and Follicular Lymphoma
In February 2021, the FDA approved Ukoniq (umbralisib; from TG Therapeutics), an oral kinase inhibitor, for the treatment of adults with relapsed or refractory marginal-zone lymphoma (MZL) or with relapsed or refractory follicular lymphoma.
FDA Approvals, News & UpdatesFollicular Lymphoma
Yescarta First Gene Therapy Approved for Follicular Lymphoma
In March 2021, the FDA approved a new indication for Yescarta (axicabtagene ciloleucel; from Kite Pharma), a CAR T-cell therapy, for the treatment of patients with relapsed or refractory follicular lymphoma who have received 2 or more lines of systemic therapy.
FDA Approvals, News & UpdatesMultiple Myeloma
FDA Approves Abecma, First CAR T-Cell Therapy for Multiple Myeloma
In March 2021, the FDA approved Abecma (idecabtagene vicleucel; from Bristol Myers Squibb/Bluebird Bio), a BCMA-directed, genetically modified CAR T-cell therapy, for the treatment of adults with multiple myeloma whose disease did not respond to, or returned, after 4 or more lines of therapy.
Last modified: October 27, 2018

Subscribe to CONQUER: the patient voice magazine

Receive timely cancer news & updates, patient stories, and more.

Country