REQUIRED DOCUMENTATIONThe individual's medical record must reflect the medical necessity for the care provided. These medical records may include but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the drug.
DIAGNOSTIC TESTS FOR HER2 PROTEIN EXPRESSION TESTINGHER2 protein overexpression is detected either by immunohistochemical (IHC) assay that measures the amount of HER2 receptor protein on the surface of cells in a breast cancer tissue sample or with a type of in situ hybridization (ISH) test for gene amplification (e.g., fluorescence in situ hybridization [FISH], chromogenic in situ hybridization [CISH], dual in situ hybridization [DISH]). The US Food and Drug Administration (FDA) has approved several commercially available tests to aid in the selection of individuals with breast cancer for datopotamab deruxtecan-dlnk (Datroway). The National Comprehensive Cancer Network (NCCN) and American Society of Clinical Oncology (ASCO) guidelines (2018) further recommend that IHC assay and ISH testing should only be done at laboratories that are accredited to perform HER2 testing.
The NCCN and ASCO both have issued guidelines for HER2 testing in invasive breast cancer that call for confirming a borderline or equivocal result:
The safety of datopotamab deruxtecan-dlnk (Datroway) was evaluated in 360 individuals with unresectable or metastatic HR-positive, HER2-negative (IHC 0, IHC1+ or IHC2+/ISH-) breast cancer who received at least one dose of deruxtecan-dlnk (Datroway) 6 mg/kg in TROPION-Breast01. Deruxtecan-dlnk (Datroway) was administered by intravenous infusion once every 3 weeks. The median duration of treatment was 6.7 months (range, 0.7 months to 16.1 months) for individuals who received datopotamab deruxtecan-dlnk (Datroway). Serious adverse reactions occurred in 15% of individuals who received deruxtecan-dlnk (Datroway). Serious adverse reactions in more than 0.5% of individuals who received deruxtecan-dlnk (Datroway) were urinary tract infection (1.9%), COVID-19 infection (1.7%), interstitial lung disease (ILD)/pneumonitis (1.1%), acute kidney injury, pulmonary embolism, vomiting, diarrhea, hemiparesis, and anemia (0.6% each). Fatal adverse reactions occurred in 0.3% of individuals who received deruxtecan-dlnk (Datroway) and were due to ILD/pneumonitis. The study demonstrated a statistically significant improvement in PFS in patients randomly assigned to deruxtecan-dlnk (Datroway) compared to chemotherapy.
The efficacy of datopotamab deruxtecan-dlnk (Datroway) was evaluated in a pooled subgroup of individuals with locally advanced or metastatic EGFR-mutated NSCLC who were enrolled across two clinical studies: TROPION-Lung05 and TROPION-Lung01. TROPION-Lung05 (NCT04484142) was a global, multicenter, single-arm, open-label trial in individuals with previously treated NSCLC with an actionable genomic alteration; TROPION-Lung01 (NCT04656652) was a global, multicenter, randomized, active-controlled, open-label trial in individuals with previously treated NSCLC with or without an actionable genomic alteration. For both trials, eligible individuals with EGFR-mutated NSCLC must have previously received an EGFR-directed therapy and platinum-based chemotherapy. Individuals with a history of ILD/pneumonitis requiring treatment with steroids, ongoing ILD/pneumonitis, or clinically significant corneal disease at screening were ineligible. Individuals who had brain metastases that were untreated and symptomatic were also ineligible. Individuals received deruxtecan-dlnk (Datroway) 6 mg/kg by intravenous infusion every 3 weeks until unacceptable toxicity or disease progression.
For the pooled efficacy population, the major efficacy outcome measure was overall response rate (ORR). An additional efficacy outcome was duration of response (DOR). Efficacy was assessed in 114 individuals with EGFR-mutated NSCLC. Fifty-three percent (53%) of individuals had tumors with exon 19 deletions, 34% had exon 21 L858R mutations, 28% had T790M mutations, 2.6% had exon 20 insertion mutations and 14% had other EGFR mutations. Four percent (4.4%) of individuals received one prior line of systemic therapy, 39% received two prior lines of systemic therapy, and 57% received three or more prior lines of systemic therapy in the locally advanced or metastatic setting. The confirmed ORR was 35.8% (95% CI, 27.8–44.4) overall, and 43.6% (95% CI, 32.4–55.3) and 23.5% (95% CI, 10.7–41.2) in those with EGFR mutations and ALK rearrangements, respectively. The median DOR was 7.0 months (95% CI, 4.2–9.8), and the overall disease control rate was 78.8% (95% CI, 71.0–85.3). The most common treatment-related adverse event was stomatitis (preferred term; any grade: 56.2%; grade ≥3: 9.5%). Five (3.6%) individuals experienced adjudicated treatment-related ILD/pneumonitis, with one (0.7%) grade 5 event.
OFF-LABEL INDICATION
There may be additional indications contained in the Policy section of this document due to evaluation of criteria highlighted in the Company’s off-label policy, and/or review of clinical guidelines issued by leading professional organizations and government entities.
Elsevier’s Clinical Pharmacology Compendium. Datopotamab deruxtecan-dlnk (Datroway). [Clinical Key Web site]. 12/16/2024. Available at: https://www.clinicalkey.com/#!/ [via subscription only]. Accessed June 10, 2025.Lexi-Drugs Compendium. Datopotamab deruxtecan-dlnk. [Lexicomp Online Web site]. 05/28/2025. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed June 10, 2025.National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology - Breast Cancer. V4.2025. [NCCN Web site]. 04/17/2025. Available at: http://www.nccn.org/professionals/physician_gls/pdf/breast.pdf [via free subscription]. Accessed June 10, 2025.
Truven Health Analytics. Micromedex® DrugDex® Compendium. Datopotamab deruxtecan-dlnk, Datroway. Greenwood Village, CO. [Micromedex® Solutions Web site]. 04/07/2025. Available at: http://www.micromedexsolutions.com/micromedex2/librarian [via subscription only]. Accessed June 10, 2025.US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Drugs@FDA. Datopotamab deruxtecan-dlnk (Datroway). [FDA Web site]. Original: 01/17/25. Available at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm. Accessed June 10, 2025.US Food and Drug Administration (FDA). Devices@FDA (HER2). Available at: http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm. Accessed June 10, 2025.US Food and Drug Administration (FDA). Datopotamab deruxtecan-dlnk (Datroway) prescribing information & approval letter. [FDA Web site]. 01/2025. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761394s000lbl.pdf. Accessed June 10, 2025.
Wolff AC, Somerfield MR, Dowsett M, et al. Human epidermal growth factor receptor 2 testing in breast cancer. [ASCO.] 02/14/25. Available at: https://www.asco.org/research-guidelines/quality-guidelines/guidelines/breast-cancer#/9751. Accessed June 10, 2025.
J9011 Injection, datopotamab deruxtecan-dlnk, 1 mg
