Find examples of the clinical trials submitted to and reviewed by regulatory agencies in the approval of a diffuse large B cell lymphoma (DLBCL) indication.
After determining which products are indicated for a medical condition of interest, it is a challenge to determine the exact clinical studies reviewed by the regulators to support approval for this specific indication. Clinical trial registries list most studies conducted in the development of a product but it is not clear which of them contributed to the regulatory decisions.
Using our centralized regulatory research platform, products associated with DLBCL were identified. Those indicated for DLBCL were then confirmed based on their product labels. Clinical studies that have supported these approvals were then identified, grouped, and analyzed.
Select the search settings “FDA” – “EMA” – “Health Canada”
Query the database for Diffuse Large B Cell Lymphoma
Download data tables from the Analytics tab
Adjust search settings to “FDA” “Label”
(optional) Assess matched content by section
Identify FDA-approved products indicated for DLBCL
Across the databases of FDA, EMA, and Health Canada, we identified 242 products associated with diffuse large B cell lymphoma.
A total of 85 FDA-approved products were found to be associated with DLBCL, with 16 of them mentioning DLBCL in their product labels. This association was primarily related to adverse events, with 63% of these products listing DLBCL in the adverse reactions section of their labels. In addition, more than half of the products referred to DLBCL in the Clinical Studies section of the labels.
Figure 1: DLBCL-associated FDA products by label section
A manual review of these product labels revealed that 6 out of the 16 FDA-approved products are indicated for DLBCL (counting multiple rituximab products as one). This is further confirmed with the search by section function, where DLBCL was found to be associated with the “Indications and Usage” section of these product labels.
Table 1: List of products approved by the FDA for diffuse large B cell lymphoma (DLBCL)
|Brand Name||Generic Name|
|RITUXAN HYCELA||hyaluronidase; rituximab|
The clinical studies supporting these DLBCL approvals were then pulled from the platform’s clinical trial datasets. These are summarized in Table 2.
Table 2: Examples of clinical studies that supported FDA approvals for DLBCL
|Study Phase||# Patients||Study Designs||# Measures||# Sites|
|Phase II||145||Single arm, open label||21||37|
|Phase II||81||Single arm, open label||5||53|
|Phase I/II||331||Randomized, open label||47||62|
|Phase II||244||Randomized, open label||11||178|
|Phase III||572||Randomized, open label||14||186|