IMHO #FDA #AcceleratedApproval 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 #cancer 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

Belanatamab withdrawn: @oncology RT @CancerDoc: The #BCMA #ADC belanatamab mafodin-blmf was withdrawn from the US (#AcceleratedApproval in August 2008) after DREAMM-3 P3 confirmatory trial (belantamab vs. PomDex) for patients with #RRMM showed that PFS did not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 #FDA #AcceleratedApproval mechanism works as it should!!!

https://www.medscape.com/viewarticle/984437

The #BCMA #ADC belanatamab mafodin-blmf was withdrawn from the US (#AcceleratedApproval in August 2008) after DREAMM-3 P3 confirmatory trial (belantamab vs. PomDex) for patients with #RRMM showed that PFS did not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 #FDA #AcceleratedApproval mechanism works as it should!!!

https://www.medscape.com/viewarticle/984437