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 First insight into the breakthrough designated (BTD) drugs, including approvals granted in oncology, reflect the situation as of August 30, 2014. This insight is based on data culled from publicly available information.

 This competitive regulatory informational EBook is intended to help guide oncology drug development sponsors to 

  • identify and infer the criteria necessary to increase the probability of success in achieving BTD designation for oncology drugs;
  • enable sponsors to get an idea about the type and magnitude of evidence necessary for a product to demonstrate substantial improvement over available therapies;
  • get a glimpse of the current thinking of FDA decision makers to assess a product as to its breakthrough potential thus avoiding unnecessary work to request a BTD; and
  • analyze and use the data to gauge the profile of competitive products to craft clinical and regulatory strategy for sponsor's own development pipeline.

  Summary of the Key Findings

  • 42% (21/50) of total granted BTD drugs (based on public announcement) are in oncology (both small molecules and biologics combined not including multiple indications for the same drug).
    • Out of 21 granted in Oncology: 47% (10/21) are in solid tumors and 52% (11/21) are in hematological cancers
  • 77% (7/9) of all therapeutics combined approved BTD drugs are in oncology (not including multiple indications for the same drug).
    • 71% (5/7) of approved BTD granted oncology drugs are in hematological cancers including one for supportive care  in hematology
    • 28% (2/7) are in solid tumors, 1 each for NSCLC and advanced melanoma
  • 42% (3/7) of BTD-granted oncology drugs were approved via accelerated approval (AA) including one already converted to full/regular approval.
    • Accelerated approvals (AA) include two new NDAs (new molecular entities) and one new BLA (new biological entity).
  • 57% (4/7) were via full/regular approval
    • Full approvals include two new BLAs (new biological entities) and two sBLAs


Ebook: First insight into the breakthrough designated (BTD) drugs, including approvals granted in oncology



Only $10.99



NOTE: 5% of the proceeds will be donated to American Cancer Society.

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Insight into BTD Drugs-Oncology




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