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          <dc:title>Rocbrutinib: First Approval</dc:title>
          <dc:creator>Simon Fung (14588847)</dc:creator>
          <dc:subject>Medicine</dc:subject>
          <dc:subject>Cancer</dc:subject>
          <dc:subject>Rocbrutinib</dc:subject>
          <dc:subject>Mantle cell lymphoma</dc:subject>
          <dc:subject>B-cell malignancies</dc:subject>
          <dc:subject>review</dc:subject>
          <dc:subject>AdisInsight Report</dc:subject>
          <dc:description>&lt;p dir="ltr"&gt;&lt;b&gt;Funding &lt;/b&gt;The preparation of this review was not supported by any external funding.&lt;/p&gt;&lt;p dir="ltr"&gt;&lt;b&gt;Declarations&lt;/b&gt;&lt;/p&gt;&lt;p dir="ltr"&gt;&lt;b&gt;Authorship and Conflict of interest &lt;/b&gt;During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. S. Fung is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to this article and are responsible for its content.&lt;/p&gt;&lt;p dir="ltr"&gt;Additional information about this Adis Drug Review can be found &lt;a href="http://www.springer.com/gp/adis/products-services/adis-journals-newsletters/adis-drug-reviews" target="_blank"&gt;&lt;b&gt;here&lt;/b&gt;&lt;/a&gt;.&lt;/p&gt;&lt;p dir="ltr"&gt;&lt;b&gt;Abstract&lt;/b&gt;&lt;/p&gt;&lt;p dir="ltr"&gt;Rocbrutinib (麓可达; LP-168) is a fourth generation Bruton's tyrosine kinase (BTK) inhibitor with both covalent and non-covalent modes of binding, which allow it to inhibit both wildtype as well as mutant variants of BTK. It is being developed by Lupeng Pharmaceuticals primarily as a treatment for patients with B-cell malignancies. Rocbrutinib received its first approval in June 2026 in China for use in adult patients with mantle cell lymphoma (MCL) that is relapsed or refractory to BTK inhibitors, and who have received ≥ 2 systemic therapies (including BTK inhibitors). This article summarizes the milestones in the development of rocbrutinib leading to its first approval in this indication.&lt;/p&gt;&lt;p dir="ltr"&gt;© Springer Nature Switzerland AG 2026&lt;/p&gt;</dc:description>
          <dc:date>2026-09-30T20:53:59Z</dc:date>
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