Martin Michaelis (he/him)<p>The limitations of <a href="https://mastodonapp.uk/tags/AcceleratedApproval" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>AcceleratedApproval</span></a>: "...of cancer drugs granted accelerated approval from 2013 to 2017, 41% (19/46) did not improve overall survival or quality of life in confirmatory trials after more than 5 years of follow-up..." <a href="https://mastodonapp.uk/tags/drug" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>drug</span></a> <a href="https://mastodonapp.uk/tags/Cancer" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>Cancer</span></a> </p><p><a href="https://jamanetwork.com/journals/jama/fullarticle/2817337" rel="nofollow noopener" translate="no" target="_blank"><span class="invisible">https://</span><span class="ellipsis">jamanetwork.com/journals/jama/</span><span class="invisible">fullarticle/2817337</span></a></p>
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#acceleratedapproval
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Matt Willemsen<p>Less Than 50% of Accelerated Approvals Show Clinical Benefit<br><a href="https://www.medscape.com/viewarticle/less-than-50-accelerated-approvals-show-clinical-benefit-2024a10006nm?src=rss&icd=login_success_email_match_norm" rel="nofollow noopener" translate="no" target="_blank"><span class="invisible">https://www.</span><span class="ellipsis">medscape.com/viewarticle/less-</span><span class="invisible">than-50-accelerated-approvals-show-clinical-benefit-2024a10006nm?src=rss&icd=login_success_email_match_norm</span></a> <a href="https://mastodon.social/tags/medicine" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>medicine</span></a> <a href="https://mastodon.social/tags/AcceleratedApproval" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>AcceleratedApproval</span></a> <a href="https://mastodon.social/tags/ClinicalBenefit" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>ClinicalBenefit</span></a></p>
Alex 🍁 🇨🇭<p>FDA’s ‘Accelerated Approval’ Pathway For Drugs Is Important, But Imperfect</p><p><a href="https://mastodon.social/tags/FDA" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>FDA</span></a> <a href="https://mastodon.social/tags/AcceleratedApproval" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>AcceleratedApproval</span></a></p><p><a href="https://www.acsh.org/news/2023/05/25/fda%E2%80%99s-%E2%80%98accelerated-approval%E2%80%99-pathway-drugs-important-imperfect-17046" rel="nofollow noopener" target="_blank"><span class="invisible">https://www.</span><span class="ellipsis">acsh.org/news/2023/05/25/fda%E</span><span class="invisible">2%80%99s-%E2%80%98accelerated-approval%E2%80%99-pathway-drugs-important-imperfect-17046</span></a></p>
Filip Janku<p>IMHO <a href="https://med-mastodon.com/tags/FDA" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>FDA</span></a> <a href="https://med-mastodon.com/tags/AcceleratedApproval" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>AcceleratedApproval</span></a> works really well in overwhelming number of cases. I hope whatever measures are planned this mechanism will not be taken away from patients with life-threatening diseases such as <a href="https://med-mastodon.com/tags/cancer" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>cancer</span></a> <a href="https://apnews.com/article/health-cancer-business-congress-drug-approvals-e029b9f3f72b4282ad39d2d00902edfe?utm_campaign=KHN%3A%20First%20Edition&utm_medium=email&_hsmi=236974285&_hsenc=p2ANqtz-8dt3joiTlbD5v_9DVOpdymym5rAyMYaD3klu94iJadZAvz4_Uw3mlwEEmNURWl7ckpCmef1-cIegNeLTDXXBeXS7oXww&utm_content=236958556&utm_source=hs_email" rel="nofollow noopener" target="_blank"><span class="invisible">https://</span><span class="ellipsis">apnews.com/article/health-canc</span><span class="invisible">er-business-congress-drug-approvals-e029b9f3f72b4282ad39d2d00902edfe?utm_campaign=KHN%3A%20First%20Edition&utm_medium=email&_hsmi=236974285&_hsenc=p2ANqtz-8dt3joiTlbD5v_9DVOpdymym5rAyMYaD3klu94iJadZAvz4_Uw3mlwEEmNURWl7ckpCmef1-cIegNeLTDXXBeXS7oXww&utm_content=236958556&utm_source=hs_email</span></a></p>
C. Harris Floudas<p>Belanatamab withdrawn: @oncology RT @CancerDoc: The <a href="https://mstdn.social/tags/BCMA" class="mention hashtag" rel="tag">#<span>BCMA</span></a> <a href="https://mstdn.social/tags/ADC" class="mention hashtag" rel="tag">#<span>ADC</span></a> belanatamab mafodin-blmf was withdrawn from the US (<a href="https://mstdn.social/tags/AcceleratedApproval" class="mention hashtag" rel="tag">#<span>AcceleratedApproval</span></a> in August 2008) after DREAMM-3 P3 confirmatory trial (belantamab vs. PomDex) for patients with <a href="https://mstdn.social/tags/RRMM" class="mention hashtag" rel="tag">#<span>RRMM</span></a> showed that PFS did not reach statistical significance (11.2 vs 7 months; HR, 1.03; 95% CI, 0.72 – 1.47). Another example that <a href="https://mstdn.social/tags/FDA" class="mention hashtag" rel="tag">#<span>FDA</span></a> <a href="https://mstdn.social/tags/AcceleratedApproval" class="mention hashtag" rel="tag">#<span>AcceleratedApproval</span></a> mechanism works as it should!!! </p><p><a href="https://www.medscape.com/viewarticle/984437" target="_blank" rel="nofollow noopener" translate="no"><span class="invisible">https://www.</span><span class="">medscape.com/viewarticle/984437</span><span class="invisible"></span></a></p>
Filip Janku<p>The <a href="https://med-mastodon.com/tags/BCMA" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>BCMA</span></a> <a href="https://med-mastodon.com/tags/ADC" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>ADC</span></a> belanatamab mafodin-blmf was withdrawn from the US (<a href="https://med-mastodon.com/tags/AcceleratedApproval" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>AcceleratedApproval</span></a> in August 2008) after DREAMM-3 P3 confirmatory trial (belantamab vs. PomDex) for patients with <a href="https://med-mastodon.com/tags/RRMM" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>RRMM</span></a> showed that PFS did not reach statistical significance (11.2 vs 7 months; HR, 1.03; 95% CI, 0.72 – 1.47). Another example that <a href="https://med-mastodon.com/tags/FDA" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>FDA</span></a> <a href="https://med-mastodon.com/tags/AcceleratedApproval" class="mention hashtag" rel="nofollow noopener" target="_blank">#<span>AcceleratedApproval</span></a> mechanism works as it should!!! </p><p><a href="https://www.medscape.com/viewarticle/984437" rel="nofollow noopener" target="_blank"><span class="invisible">https://www.</span><span class="ellipsis">medscape.com/viewarticle/98443</span><span class="invisible">7</span></a></p>
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