Kaitlyn D’Onofrio

DocwireNews

The Food and Drug Administration (FDA) approved once-weekly&nbsp;carfilzomib in combination with dexamethasone&nbsp;to treat&nbsp;relapsed and refractory multiple myeloma.&nbsp;The FDA&rsquo;s expanded approval follows a&nbsp;randomized, open-label, phase 3 A.R.R.O.W. trial of patients aged&nbsp;&ge;&nbsp;18 years with relapsed and refracted multiple myeloma who had already underwent two or three treatments. Patients were randomly assigned to receive&nbsp;carfilzomib&nbsp;either&nbsp;once a week (70 mg/m2)&nbsp;(n = 240)&nbsp;or twice a week (27 mg/m2)&nbsp;(n = 238), and all patients also received dexamethasone.&nbsp;The once a week group intravenously received carfilzomib (30 min) on days 1, 8, and 15 of all cycles&nbsp;(20 mg/m2&nbsp;day 1 [cycle 1]; 70 mg/m2&nbsp;thereafter). The twice a week group received carfilzomib intravenously for 10 minutes on days 1, 2, 8, 9, 15, and 16 (20 mg/m2&nbsp;days 1 and 2 during cycle 1; 27 mg/m2&nbsp;thereafter).&nbsp;<blockquote class="twitter-tweet" data-width="500" data-dnt="true">
Great news for patients! The FDA has approved a once-weekly dosing option of carfilzomib (Kyprolis) to use in combination with dexamethasone for patients with relapsed/refractory multiple myeloma. Learn more: <a href="https://t.co/mT91aswj3F">https://t.co/mT91aswj3F</a>
&mdash; Multiple Myeloma RF (@theMMRF) <a href="https://twitter.com/theMMRF/status/1046793996738154497?ref_src=twsrc%5Etfw">October 1, 2018</a>
</blockquote><script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script><blockquote class="twitter-tweet" data-width="500" data-dnt="true">
Phase I/II study of once-weekly <a href="https://twitter.com/hashtag/Kyprolis?src=hash&amp;ref_src=twsrc%5Etfw">#Kyprolis</a>, <a href="https://twitter.com/hashtag/Pomalyst?src=hash&amp;ref_src=twsrc%5Etfw">#Pomalyst</a>, and low-dose dex for relapsed/refractory <a href="https://twitter.com/hashtag/myeloma?src=hash&amp;ref_src=twsrc%5Etfw">#myeloma</a> finds ORR was 54% and median PFS was 10.3 months: <a href="https://t.co/lUbW7D4zlT">https://t.co/lUbW7D4zlT</a>. <a href="https://t.co/t7kAw9IiET">pic.twitter.com/t7kAw9IiET</a>
&mdash; Robert Z. Orlowski (@Myeloma_Doc) <a href="https://twitter.com/Myeloma_Doc/status/1046867348186050560?ref_src=twsrc%5Etfw">October 1, 2018</a>
</blockquote><script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>The once a week group had higher median progression-free survival rates compared to the twice a week group&nbsp;(11.2 months [95% CI 8.6&ndash;13.0] vs 7.6 months [5.8&ndash;9.2]; hazard ratio [HR] 0.69, 95% CI 0.54&ndash;0.83; p&nbsp;=&nbsp;0.0029).&nbsp;Once weekly patients were less likely to experience grade 3 or worse cardiac failure (3% [n = 7] vs 4% [n = 10]). Grade 3 or worse adverse events occurred more frequently among the once weekly group than the twice weekly group (68% [n = 161] vs 62% [n = 145]), the most common of which were&nbsp;anemia, pneumonia, and thrombocytopenia (18% [n = 42] vs&nbsp;18% [n = 42],&nbsp;10% [n = 24]&nbsp;vs&nbsp;7% [n = 16], and&nbsp;7% [n = 17]&nbsp;vs 7%&nbsp;[n = 16],&nbsp;respectively for once weekly carfilzomib vs twice weekly carfilzomib).&nbsp;The once weekly and twice weekly groups saw 58 and 68 deaths, respectively, at the time of data cutoff.&nbsp;<blockquote class="twitter-tweet" data-width="500" data-dnt="true">
Breaking news: <a href="https://twitter.com/US_FDA?ref_src=twsrc%5Etfw">@US_FDA</a> approves a new dosing option for KYPROLIS&reg; (carfilzomib). Learn more here: <a href="https://t.co/l6aJrTvYyl">https://t.co/l6aJrTvYyl</a>
&mdash; Amgen &#129514;&#128300;&#129516; (@Amgen) <a href="https://twitter.com/Amgen/status/1046749757912371201?ref_src=twsrc%5Etfw">October 1, 2018</a>
</blockquote><script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>Carfilzomib, marketed under the name&nbsp;Kyprolis, is manufactured by Amgen.&nbsp;The FDA&nbsp;<a href="https://www.drugs.com/newdrugs/fda-approves-kyprolis-patients-advanced-multiple-myeloma-3393.html">first approved</a>&nbsp;the drug in 2012.&nbsp;<a href="https://proddocwire.wpengine.com/hematology-oncology/role-of-the-rank-rankl-pathway-in-multiple-myeloma/">Role of the RANK/RANKL Pathway in Multiple Myeloma</a>&nbsp;<a href="https://proddocwire.wpengine.com/hematology-oncology/going-the-distance-are-we-losing-patients-along-the-multiple-myeloma-treatment-pathway/">Going the distance: Are we losing patients along the multiple myeloma treatment pathway?</a>&nbsp;<a href="https://proddocwire.wpengine.com/medical-oncology/semaphorin-3a-inhibits-multiple-myeloma-progression-in-a-mouse-model/">Semaphorin-3A inhibits multiple myeloma progression in a mouse model</a>&nbsp;Sources:&nbsp;<a href="https://www.healio.com/hematology-oncology/myeloma/news/online/%7Bb19930b1-ab26-4d7b-96ce-31f6da965f10%7D/fda-approves-once-weekly-kyprolis-for-relapsed-refractory-multiple-myeloma">Healio</a>,&nbsp;<a href="https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(18)30354-1/fulltext">The&nbsp;Lancet</a>

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FDA Approves Carfilzomib in Combination with Dexamethasone for Multiple Myeloma Patients

Oncology

The Food and Drug Administration (FDA) approved once-weekly carfilzomib in combination with dexamethasone to treat relapsed and refractory multiple myeloma.  ...

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