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  ES10 - Oncology Drug Approval: Challenges and Opportunities (ID 13)

  • Event: WCLC 2019
  • Type: Educational Session
  • Track: Advanced NSCLC
  • Presentations: 1
  • Now Available
  • Moderators:Caicun Zhou, Alice T. Shaw
  • Coordinates: 9/08/2019, 13:30 - 15:00, Toronto (1985)

  • 29277

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    ES10.04 - European Medicines Agency (Now Available) (ID 3208)

    13:30 - 15:00  |  Presenting Author(s): Jorge Camarero
    • Abstract
    • Presentation
    • Slides

    Abstract
    

    Oncology Drugs Approval: Challenges and Opportunities

    In recent years, the development of new drugs in the oncology field has notably increased. This growth in oncology clinical trials appears to be mainly associated with the increasing knowledge in pathophysiology and molecular medicine in oncology. Targeted therapies have been approved, overall, on the basis of its ability to prolong progression free survival and/or life expectancy of patients. In addition, immunotherapy has arisen as a turning point in the treatment of cancer, opening a new era and setting up a milestone in the current armamentarium. However, the regulatory decision making process behind some of the approvals for these products have proven difficult and lead to important uncertainties still to be addressed. Such unanswered questions relate, among others, to the target population, subgroups of patients partially covered by authorized indications and limitations on important aspects such as duration and combination of treatments. Likewise, this increase in new molecules development poses a remarkable pressure on regulators, clinicians and payers, who albeit from different perspectives, face the very same problem of how to ensure (timely) access to patients of new authorized products. From a regulatory perspective, randomized clinical trials remain the gold standard for adequate assessment of both efficacy and safety. Nevertheless, conducting single arm studies is becoming a commonly approach for companies to speed up regulatory approval in those situations where there is an unmet medical need. The latter cast important doubts on when, where and how this strategy can be accepted.

    Last but not least, new clinical trials designs and the proposal of using Real Word Evidence/Real World Data to complement non-compelling clinical development, are creating a new parading when it comes to making a decision upon the benefit-risk balance

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