aBLA Filing Intelligence & Biosimilar Opportunity

Datroway

Datopotamab Deruxtecan-Dlnk

Anticancer

Intravenous Injection

Datroway is an antibody-drug conjugate for adults with advanced non-small cell lung cancer that has an EGFR mutation and progressed after standard treatment. It delivers targeted chemotherapy directly to cancer cells to control tumor growth.

Approval Date

17-Jan-25

Data Exclusivity Expiry

17-Jan-29

Market Exclusivity Expiry

17-Jan-37

Commercial snapshot

Market performance & projections

Revenue ($M)

385

CAGR (%)

60.39%

Projected sales, 2026–2032 ($M)

Analyst projection, $M per year

2026

821

2027

1,268

2028

1,903

2029

2,548

2030

3,158

2031

3,740

2032

4,271

Molecule profile

Details & specifications

Molecule

Datopotamab Deruxtecan-Dlnk

Innovator

DAIICHI SANKYO INC

Dosage Form

Intravenous Injection

Strength

100 mg

Therapeutic Category

Anticancer

Usage

To treat unresectable or metastatic, HR-positive, HER2-negative breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease

Good to know

Frequently asked questions

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