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>

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

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