Last updated: March 8, 2026
What is the Drug Represented by NDC 60687-0662?
NDC 60687-0662 corresponds to Tucatinib (Well Margin), marketed under the brand Tukysa by Seattle Genetics. It is an oral tyrosine kinase inhibitor approved by the FDA in April 2020.
Indications and Market Position
Tucatinib is approved for use in combination with trastuzumab and capecitabine for adults with HER2-positive metastatic breast cancer, specifically following prior therapy. It targets HER2-positive, unresectable or metastatic breast cancer with central nervous system metastases.
Market Size and Patient Population
Target Patient Demographics:
- HER2-positive breast cancer
- Metastatic or unresectable cases
- Patients with brain metastases
Estimated Patient Population:
- United States: Approximately 8,000-10,000 annual new cases of HER2-positive metastatic breast cancer[1].
- Market Penetration: Given existing competition (e.g., trastuzumab emtansine, tucatinib is positioned for second-line therapy), initial penetration is estimated at 30-50%, with potential growth based on clinical data and utilization patterns.
Market Drivers:
- Approval of tucatinib for brain metastases expands therapy options.
- Increasing awareness and diagnosis of HER2-positive cases.
- Growing number of patients receiving targeted therapy, driven by oncology treatment guidelines.
Market Challenges:
- Competition from established therapies (e.g., trastuzumab deruxtecan, tucatinib's competitors).
- Cost containment pressures affecting reimbursement.
Price Benchmarks and Projections
Current Pricing Benchmarks:
- List Price: Approximately $11,200 to $13,200 per month per patient, based on wholesale acquisition costs (WAC)[2].
- Per-Patient Annual Cost: Roughly $134,400 to $158,400.
Price Trends:
- Initial prices reflect novel targeted therapy premiums.
- Future price adjustments are influenced by payer negotiations, value-based agreements, and market competition.
- Price erosion typically occurs within 3-5 years; down to 5-15% based on market dynamics.
Future Price Projections (Next 3–5 Years):
| Year |
Expected Price Range (per month) |
Rationale |
| 2023 |
$11,200 - $13,200 |
Current market prices |
| 2024 |
$10,700 - $12,600 |
Slight price erosion due to competition |
| 2025 |
$10,100 - $12,000 |
Increased payer negotiations, biosimilar pressure |
Market Revenue Forecast:
- 2023: $700 million – $1.2 billion (assuming ~6,000-8,500 treated patients annually).
- 2025: $600 million – $1 billion, considering market penetration and competitive dynamics.
Competitive Landscape
| Drug Name |
Class/Mechanism |
Market Share (Estimated 2022) |
Notes |
| tucatinib (Tukysa) |
HER2 tyrosine kinase inhibitor |
~40% |
Recently gained approval for brain metastases |
| trastuzumab deruxtecan |
HER2 antibody-drug conjugate |
~30% |
Higher efficacy in some indications |
| trastuzumab emtansine |
HER2 antibody-drug conjugate |
~20% |
Established first-line agent |
Policy and Regulatory Considerations
- Pricing negotiations influence net prices.
- Potential upcoming biosimilars or generics may reduce prices.
- Value-based pricing models gaining momentum could alter standard prices.
Risks and Opportunities
Risks:
- Entry of biosimilars or generics.
- Payer resistance to high prices.
- Clinical trial results affecting market dynamics.
Opportunities:
- Broadening indications (e.g., early therapy, combination regimens).
- Expanding into international markets.
- Demonstrating superior effectiveness in resistant or CNS metastasis cases.
Key Takeaways
- NDC 60687-0662 indicates tucatinib (Tukysa).
- The current U.S. market size is driven by ~8,000–10,000 patients annually.
- List prices average approximately $11,200–$13,200 per month, equating to ~$134,400–$158,400 annually.
- Price erosion of 5–15% is anticipated over the next 3–5 years due to competition and negotiations.
- Revenue projections rely on market penetration, which is expected to stabilize around $600 million–$1 billion.
FAQs
-
What is the primary use of tucatinib?
Approved for HER2-positive metastatic breast cancer, especially in cases with brain metastases.
-
What are the main competitors?
Trastuzumab deruxtecan, trastuzumab emtansine, and other HER2-targeted therapies.
-
How does pricing compare to other targeted oncology drugs?
Similar on a monthly basis; targeted oncology drugs generally range from $10,000 to $15,000 per month.
-
What factors influence future price changes?
Payer negotiations, clinical efficacy data, market share, and potential biosimilar entry.
-
Is there potential for expanding tucatinib's indications?
Future trials or label expansions in earlier-line treatment or combination regimens could enlarge the market.
References
[1] American Cancer Society. (2022). Breast Cancer Facts & Figures.
[2] IQVIA. (2022). Healthcare Annual Review.
[3] FDA. (2020). Tucatinib Approval Letter.
[4] Market Research Future. (2022). Her2-Positive Breast Cancer Market Analysis.
