Kerri Fitzgerald

DocwireNews

The&nbsp;U.S.&nbsp;Food and Drug Administration granted accelerated approval to pembrolizumab&nbsp;for adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).&nbsp;The decision was based on results of the&nbsp;multicenter, non-randomized, open-label KEYNOTE-017&nbsp;trial, which included&nbsp;50 patients with recurrent locally advanced or metastatic MCC who had not received prior systemic therapy&nbsp;for advanced disease. Patients received pembrolizumab 2 mg/kg every&nbsp;three weeks.&nbsp;<blockquote class="twitter-tweet" data-width="500" data-dnt="true">
.<a href="https://twitter.com/US_FDA?ref_src=twsrc%5Etfw">@US_FDA</a> Approves Pembrolizumab for Merkel Cell Carcinoma <a href="https://t.co/mLgCgbjr8F">https://t.co/mLgCgbjr8F</a> <a href="https://twitter.com/hashtag/skcsm?src=hash&amp;ref_src=twsrc%5Etfw">#skcsm</a> <a href="https://twitter.com/hashtag/oncology?src=hash&amp;ref_src=twsrc%5Etfw">#oncology</a>
&mdash; The ASCO Post (@ASCOPost) <a href="https://twitter.com/ASCOPost/status/1075501526146179072?ref_src=twsrc%5Etfw">December 19, 2018</a>
</blockquote><script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>The&nbsp;overall response rate&nbsp;was 56% (95% CI, 41-70),&nbsp;with a complete response rate of 24%. The median response duration was not reached. Among the 28&nbsp;responders, 96% had&nbsp;a duration of response of more&nbsp;than 6 months and 54% had&nbsp;duration of response of more than 12 months.&nbsp;The most common adverse&nbsp;events associated with&nbsp;pembrolizumab&nbsp;monotherapy included&nbsp;fatigue, musculoskeletal pain, decreased appetite, pruritus, diarrhea, nausea, rash, pyrexia, cough, dyspnea, constipation, pain, and abdominal pain.&nbsp;<blockquote class="twitter-tweet" data-width="500" data-dnt="true">
FDA granted accelerated approval to pembrolizumab (KEYTRUDA, Merck &amp; Co. Inc.) for adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma <a href="https://t.co/a5lFffH67P">https://t.co/a5lFffH67P</a>
&mdash; FDA Oncology (@FDAOncology) <a href="https://twitter.com/FDAOncology/status/1075478641776173056?ref_src=twsrc%5Etfw">December 19, 2018</a>
</blockquote><script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>The recommended pembrolizumab dose for MCC is 200 mg administered as a 30-minute intravenous&nbsp;(IV)&nbsp;infusion every&nbsp;three&nbsp;weeks for adults and&nbsp;2 mg/kg (maximum of 200 mg) administered as&nbsp;a 30-minute&nbsp;IV&nbsp;infusion every three&nbsp;weeks&nbsp;for&nbsp;pediatric patients (younger than 18 years).&nbsp;<a href="https://proddocwire.wpengine.com/hematology-oncology/fda-approves-combination-therapy-for-melanoma/">FDA approves a combination therapy for melanoma.</a>&nbsp;&nbsp;<a href="https://proddocwire.wpengine.com/docwire-pick/hem-onc-picks/10-minute-test-detect-cancer/">Can a 10-minute test detect cancer?</a>Source:&nbsp;<a href="https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm628867.htm">FDA</a>

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FDA Approves Pembrolizumab to Treat Merkel Cell Carcinoma

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The U.S. Food and Drug Administration granted accelerated approval to pembrolizumab for adult and pediatric patients with recurrent locally advanced or metastatic Merkel ...

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