• Mashup Score: 3
    Project Confirm - 1 year(s) ago

    Promoting the transparency of Accelerated Approval for oncology indications

    Tweet Tweets with this article
    • What is accelerated approval? Learn about accelerated approval for oncology drugs at the FDA's Oncology Center of Excellence. Watch a short video below and visit #OCEProjectConfirm to learn more: https://t.co/eHHhpywEcK #AcceleratedApproval #OCEProjectCommunity https://t.co/SH6MLUU1gC

  • Mashup Score: 0

    GSK and Roche have pulled drugs approved on an accelerated basis, while other drugmakers win speedy approvals only after starting confirmatory studies.

    Tweet Tweets with this article
    • Success is never guaranteed in life but preparing to minimize unwanted effects of failure 😞 is imp. Impressed with #FDA plans on making sure #Acceleratedapproval gets the drugs out to pt, with checks and balance. #patientcare #mmsm #lysm https://t.co/QNl1WkjuLh

  • Mashup Score: 1

    The manufacturer is pulling the drug from the market at the request of the FDA following disappointing results from a large phase 3 confirmatory trial.

    Tweet Tweets with this article
    • #BCMA #ADC belanatamab withdrawn from the US. P3 confirmatory trial DREAMM3 (belantamab vs. PomDex) for #RRMM showed no PFS advantage (HR, 1.03; 95% CI, 0.72 – 1.47). #FDA #AcceleratedApproval mechanism works as it should!!! https://t.co/6zAp0pXgj7 https://t.co/AjKeDDnH2L

  • Mashup Score: 2
    Project Confirm - 1 year(s) ago

    Promoting the transparency of Accelerated Approval for oncology indications

    Tweet Tweets with this article
    • FDA's Accelerated Approval is 30 years old this year. The first #AcceleratedApproval in oncology was granted on October 4, 1995, to bicalutamide in combination with an LHRH analogue for advanced #prostatecancer. Learn more with #OCEProjectConfirm 👇 https://t.co/SByEFforxu https://t.co/QWiiUMsKkY