https://neoplasm.org/index.php?action=history&feed=atom&title=Update 2026-06-08T23:28:10Z Revision history for this page on the wiki MediaWiki 1.44.2 https://neoplasm.org/index.php?title=Update&diff=101&oldid=prev 2025-12-31T17:53:58Z

<p>Created page with &quot;&lt;includeonly&gt; {| class=&quot;wikitable neoplasm-table&quot; ! Approval date ! Medication (Brand) ! Company ! Indication ! Regulatory type ! Trial(s) cited on FDA approval page |- | 2025-07-02 | Sunvozertinib (Zegfrovy) | Dizal Pharma | EGFR exon 20 insertion NSCLC after platinum therapy | Accelerated approval | <a href="/index.php?title=WU-KONG1&amp;action=edit&amp;redlink=1" class="new" title="WU-KONG1 (page does not exist)">WU-KONG1</a> |- | 2025-07-02 | Linvoseltamab-gcpt (Lynozyfic) | Regeneron | Relapsed/refractory multiple myeloma (≥4 prior lines) | Accelerated approval | <a href="/index.php?title=LINKER-MM1&amp;action=edit&amp;redlink=1" class="new" title="LINKER-MM1 (page does not exist)">LINKER-MM1</a>...&quot;</p> <p><b>New page</b></p><div>&lt;includeonly&gt;<br /> {| class=&quot;wikitable neoplasm-table&quot;<br /> ! Approval date<br /> ! Medication (Brand)<br /> ! Company<br /> ! Indication<br /> ! Regulatory type<br /> ! Trial(s) cited on FDA approval page<br /> |-<br /> | 2025-07-02<br /> | Sunvozertinib (Zegfrovy)<br /> | Dizal Pharma<br /> | EGFR exon 20 insertion NSCLC after platinum therapy<br /> | Accelerated approval<br /> | [[WU-KONG1]]<br /> |-<br /> | 2025-07-02<br /> | Linvoseltamab-gcpt (Lynozyfic)<br /> | Regeneron<br /> | Relapsed/refractory multiple myeloma (≥4 prior lines)<br /> | Accelerated approval<br /> | [[LINKER-MM1]]<br /> |-<br /> | 2025-08-06<br /> | Dordaviprone (Modeyso)<br /> | Jazz Pharmaceuticals<br /> | H3 K27M–mutant diffuse midline glioma<br /> | Accelerated approval<br /> | [[ACTION]]<br /> |-<br /> | 2025-08-08<br /> | Zongertinib (Hernexeos)<br /> | Boehringer Ingelheim<br /> | HER2-mutated NSCLC after prior therapy<br /> | Accelerated approval<br /> | [[BEAMION-LUNG-1]]<br /> |-<br /> | 2025-09-09<br /> | Gemcitabine intravesical system (Inlexzo)<br /> | Janssen<br /> | BCG-unresponsive NMIBC with CIS<br /> | Traditional approval<br /> | [[SUNRISE-1]]<br /> |-<br /> | 2025-09-25<br /> | Imlunestrant (Inluriyo)<br /> | Eli Lilly<br /> | ESR1-mutated ER+/HER2− metastatic breast cancer<br /> | Traditional approval<br /> | [[EMBER-3]]<br /> |-<br /> | 2025-10-24<br /> | Revumenib (Revuforj)<br /> | Syndax Pharmaceuticals<br /> | Relapsed/refractory NPM1-mutated AML<br /> | Accelerated approval<br /> | [[AUGMENT-101]]<br /> |-<br /> | 2025-11-13<br /> | Ziftomenib (Komzifti)<br /> | Kura Oncology<br /> | Relapsed/refractory NPM1-mutated AML<br /> | Accelerated approval<br /> | [[KOMET-001]]<br /> |-<br /> | 2025-11-18<br /> | Epcoritamab-bysp (Epkinly)<br /> | Genmab<br /> | Relapsed/refractory follicular lymphoma<br /> | Traditional approval<br /> | [[EPCORE-NHL-1]]<br /> |-<br /> | 2025-12-04<br /> | Lisocabtagene maraleucel (Breyanzi)<br /> | Bristol Myers Squibb<br /> | Relapsed/refractory marginal zone lymphoma<br /> | Traditional approval<br /> | [[TRANSCEND-NHL-001]]<br /> |}<br /> &lt;/includeonly&gt;&lt;noinclude&gt;<br /> This template lists FDA oncology approvals in 2025. Trials are those explicitly cited on FDA approval pages.&lt;/noinclude&gt;</div>

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