Kerri Fitzgerald

DocwireNews

The&nbsp;U.S.&nbsp;Food and Drug Administration approved&nbsp;the combination&nbsp;encorafenib&nbsp;and&nbsp;binimetinib&nbsp;for&nbsp;the treatment of&nbsp;unresectable or metastatic melanoma with&nbsp;BRAF V600E&nbsp;or&nbsp;V600K&nbsp;mutation.&nbsp;The decision&nbsp;was based on&nbsp;results of&nbsp;the&nbsp;randomized, active-controlled, open-label, multicenter&nbsp;COLUMBUS&nbsp;trial&nbsp;that included 577 patients with&nbsp;BRAF V600E&nbsp;or&nbsp;V600K&nbsp;mutation-positive unresectable or metastatic melanoma. Patients were randomized 1:1:1&nbsp;to receive&nbsp;encorafenib&nbsp;450 mg once daily&nbsp;plus&nbsp;binimetinib&nbsp;45 mg twice daily,&nbsp;encorafenib&nbsp;300 mg once daily, or vemurafenib 960 mg twice daily.&nbsp;&nbsp;<blockquote class="twitter-tweet" data-width="500" data-dnt="true">
<a href="https://twitter.com/hashtag/ICYMI?src=hash&amp;ref_src=twsrc%5Etfw">#ICYMI</a> The <a href="https://twitter.com/US_FDA?ref_src=twsrc%5Etfw">@US_FDA</a> approved <a href="https://twitter.com/ArrayBioPharma?ref_src=twsrc%5Etfw">@ArrayBiopharma</a>'s encorafenib and binimetinib (BRAFTOVI and MEKTOVI) combination therapy for patients with unresectable or <a href="https://twitter.com/hashtag/metastaticmelanoma?src=hash&amp;ref_src=twsrc%5Etfw">#metastaticmelanoma</a> with a BRAF V600E or V600K mutation as detected by an FDA-approved test.
READ: <a href="https://t.co/KYCzOIRI5G">https://t.co/KYCzOIRI5G</a> <a href="https://t.co/1OtsQfAnvK">pic.twitter.com/1OtsQfAnvK</a>
&mdash; Rare Disease Report (@RareDR) <a href="https://twitter.com/RareDR/status/1012440753598017537?ref_src=twsrc%5Etfw">June 28, 2018</a>
</blockquote><script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>The median&nbsp;progression-free survival&nbsp;was 14.9&nbsp;months&nbsp;in the&nbsp;encorafenib&nbsp;plus&nbsp;binimetinib&nbsp;cohort&nbsp;and 7.3 months for the vemurafenib monotherapy arm (hazard ratio&nbsp;= 0.54;&nbsp;95% CI&nbsp;0.41-0.71;&nbsp;P&lt;0.0001). Overall response rates were 63% and 40%, respectively. The median response duration was 16.6 months&nbsp;and&nbsp;12.3 months, respectively.&nbsp;<blockquote class="twitter-tweet" data-width="500" data-dnt="true">
FDA approves combination of binimetinib and encorafenib for advanced <a href="https://twitter.com/hashtag/melanoma?src=hash&amp;ref_src=twsrc%5Etfw">#melanoma</a> tied to BRAF mutation <a href="https://twitter.com/hashtag/CancerResearch?src=hash&amp;ref_src=twsrc%5Etfw">#CancerResearch</a> <a href="https://t.co/VsOnubKJSb">https://t.co/VsOnubKJSb</a>
&mdash; Les Yonemoto, MD MBA (@protoninfo) <a href="https://twitter.com/protoninfo/status/1012330584239169536?ref_src=twsrc%5Etfw">June 28, 2018</a>
</blockquote><script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>The most common&nbsp;adverse&nbsp;events (AEs) associated with the&nbsp;combination&nbsp;therapy include&nbsp;fatigue, nausea, diarrhea, vomiting, abdominal pain, and arthralgia.&nbsp;Five percent of patients in the&nbsp;encorafenib&nbsp;plus&nbsp;binimetinib&nbsp;arm discontinued&nbsp;therapy&nbsp;because of&nbsp;AEs, most commonly due to&nbsp;hemorrhage and headache.&nbsp;Source: <a href="https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm611981.htm">U.S. Food and Drug Administration</a>

MarkAlain Déry, DO

Eric Griggs, MD

Measles in America: An Ongoing Problem

Infectious Disease

Roger Rodby, MD

Joel M. Topf, MD, FACP

Seldin Award Winner Advocates Online Education

NKF Spring Clinical Meetings 2025

Hatem Soliman, MD

The Future of Dendritic Cell Vaccines in HER2+ Breast Cancer: Toward De-Escalation of Chemotherapy

HER2 Breast Cancer

Latest News

FDA Approves Combination Therapy for Melanoma

Skin Cancer

The U.S. Food and Drug Administration approved the combination encorafenib and binimetinib for the treatment of unresectable or metastatic melanoma with BRAF ...

About Us

Editorial Policy

Advertising

Contact Us

eNewsletters

Contribute

Career Center

MashupMD

Blood Cancers Today

Cancer Nursing Today

GU Oncology Now

Urban Health Today

Bile Duct Cancer

Colorectal Cancer

Gastroesophageal Cancer

Gastric Cancer

GEP-NETs

GIST

Liver Cancer

Pancreatic Cancer

GI Oncology Now

Anemia

Deep Vein Thrombosis

Essential Thrombocythemia

Hemophilia

Immune Thrombocytopenic Purpura

Myelodysplastic Syndromes

Myelofibrosis

Myeloproliferative Neoplasms

Polycythemia Vera

Pulmonary Embolism

Sickle Cell Disease

Thrombocytopenia

Thrombophilia

Thrombosis

Thrombotic Thrombocytopenic Purpura

Venous Thromboembolism

von Willebrand Disease

Heme Today

Acute Kidney Injury

ADPKD

Anemia and Kidney Disease

Chronic Kidney Disease

COVID-19 and Kidney Disease

Diabetes and Hypertension

End-Stage Renal Disease

Gout

Hyperkalemia

IgAN

Kidney Transplantation

Metabolic Acidosis

Nephrology Times

HR Breast Cancer

Triple-Negative Breast Cancer

Genetics & Breast Cancer

Breast Cancers Today

Atherosclerotic Disease

Atrial Fibrillation

Heart Failure

Hypertension

Interventional Cardiology

Lipid Management

Practice Tips With Dr. Lichaa

Preventive Cardiology

Stroke

Cardiology

Breast Cancer

Gynecologic Cancer

Head and Neck Cancer

Oncology

Sleep

Urology

Diabetes

Ophthalmology

— Demodex Blepharitis

Neurology

Rheumatology

Gastroenterology

Pulmonology

Infectious Diseases

— HIV

Health and Wellness

Lupus

Future of Medicine

Orthopedics

Pharmacology

Career News

More

Conferences

CardioNerds

The Sleep Source With Dr. Morse

Rheumatology Rounds With Dr. Maheswaranathan

Partners

Expert Interviews

Subscribe