FDA Approves IV Tx for Advanced Form of NSCLC – Datroway

The FDA recently approved a new infused therapy, Datroway (detumomab deruxtecan-dlnk) from AstraZeneca, indicated for the treatment of 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.

Datroway is the first and only TROP2-directed therapy approved in the US for the treatment of lung cancer. Advanced EGFR-mutated non-small cell lung cancer (NSCLC) is a subtype of lung cancer defined by the presence of specific mutations in the epidermal growth factor receptor (EGFR) gene. These mutations make the cancer cells grow and divide more rapidly. EGFR mutations are most commonly found in adenocarcinomas.

Datroway is a weight-based therapy requiring 6 mg/kg given as an intravenous infusion once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity.

AstraZeneca did not set a list price for Datroway at time of approval.
The company did not comment on distribution plans for the product.

CLICK HERE to access prescribing information


Datroway approved in the US for patients with previously treated advanced EGFR-mutated non-small cell lung cancer

CLICK HERE to read the company press release

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