Clinical Policy: Datopotamab Deruxtecan-dlnk (Datroway) Form

# Clinical Policy: Datopotamab Deruxtecan-dlnk (Datroway)
Reference Number: CP.PHAR.715  
Effective Date: 06.01.25  
Last Review Date: 05.26  
Line of Business: Commercial, HIM/ICHRA, Medicaid  

[Coding Implications](Coding Implications)  
[Revision Log](Revision Log)  

See [Important Reminder](See Important Reminder) at the end of this policy for important regulatory and legal information.  

## Description  
Datopotamab deruxtecan-dlnk (Datroway®) is a Trop-2-directed antibody and topoisomerase inhibitor conjugate.  

## FDA Approved Indication(s)  
Datroway is indicated for the treatment of:  
- Adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy\*  
- Adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease  

\* This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial  

## Policy/Criteria  
  
   a. Triple negative (i.e., estrogen receptor-, progesterone receptor-, and HER2-negative) breast cancer (TNBC) and both of the following (i and ii):  
      i. Tumor expresses PD-L1 (Combined Positive Score [CPS] < 10);  
      ii. Disease is negative for germline BRCA 1/2 pathogenic variant;  
   b. HR-positive and HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) disease and both of the following (i and ii):  
      i. Member received prior endocrine based therapy (see Appendix B);