Kerri Fitzgerald

DocwireNews

The U.S. Food and Drug Administration&nbsp;(FDA)&nbsp;approved&nbsp;ribociclib&nbsp;in combination with an aromatase inhibitor for pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer as initial endocrine-based therapy.&nbsp;Ribociclib&nbsp;was also approved&nbsp;in combination with&nbsp;fulvestrant&nbsp;for the treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer&nbsp;as initial endocrine based therapy or following disease progression on endocrine therapy.<blockquote class="twitter-tweet" data-width="500" data-dnt="true">
Our CDK4/6 inhibitor is the first product granted approval using the FDA&rsquo;s Real-Time Oncology Review and the Assessment Aid pilot programs. Read more about the approval here: <a href="https://t.co/KQ0wwUIMiI">https://t.co/KQ0wwUIMiI</a> <a href="https://twitter.com/hashtag/NovartisNews?src=hash&amp;ref_src=twsrc%5Etfw">#NovartisNews</a>
&mdash; Novartis (@Novartis) <a href="https://twitter.com/Novartis/status/1019824192496328705?ref_src=twsrc%5Etfw">July 19, 2018</a>
</blockquote><script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>This is the first approval&nbsp;to occur through&nbsp;two new&nbsp;FDA&nbsp;pilot programs&nbsp;that seek to make the development and review of oncology agents more efficient.&nbsp;One of the programs,&nbsp;Real-Time Oncology Review, allows the FDA to review&nbsp;a bulk of the&nbsp;data before the information is formally submitted.&nbsp;Thus, upon review, the agency is familiar with the data.&nbsp;<blockquote class="twitter-tweet" data-width="500" data-dnt="true">
FDA approves first cancer drug through new oncology review pilot that enables greater&hellip; <a href="https://t.co/JCFPk1f5bJ">https://t.co/JCFPk1f5bJ</a>
&mdash; World Pharma News (@WorldPharmaNews) <a href="https://twitter.com/WorldPharmaNews/status/1019674269142409217?ref_src=twsrc%5Etfw">July 18, 2018</a>
</blockquote><script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>The second program,&nbsp;Assessment Aid, allows the applicant to organize its submission into a structured format, which provides&nbsp;a more streamlined approach to reviewing data and illustrating&nbsp;the&nbsp;FDA&rsquo;s analysis. It allows drug reviewers to focus on the key benefit-risk and labeling issues rather than administrative issues, according to the FDA.&nbsp;Source: <a href="https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613801.htm">FDA</a>

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The U.S. Food and Drug Administration (FDA) approved ribociclib in combination with an aromatase inhibitor for pre/perimenopausal or postmenopausal women with hormone ...

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