Last updated: March 8, 2026
What is the drug identified by NDC 59651-0774?
NDC 59651-0774 corresponds to Entrectinib (Rozlytrek). It is an oral tyrosine kinase inhibitor developed by Genentech (Roche) targeting NTRK gene fusions, ROS1 rearrangements, and RET mutations.
Market Landscape
Therapeutic Area and Indications
Entrectinib targets rare genetic alterations in solid tumors. Its primary indications include:
- NTRK gene fusion-positive solid tumors
- ROS1-positive non-small cell lung cancer (NSCLC)
- RET fusion-positive tumors (mainly thyroid cancers and NSCLC)
The drug gained FDA approval in 2019 for adult and pediatric patients with NTRK fusion-positive cancers and ROS1-positive NSCLC.
Market Size and Patient Population
| Indicator |
Data |
Source |
| Global oncology drug market |
Expected to reach $210B by 2026 |
[1] |
| NTRK fusion-positive cancers |
Estimated 3,000–5,000 new cases annually in the US |
[2], [3] |
| RET fusion-positive cancers |
Approximately 13,000 NSCLC cases per year in US |
[4] |
| ROS1-positive NSCLC |
About 1–2% of NSCLC cases, roughly 10,000 cases annually US |
[5] |
The rarity of NTRK and RET mutations constrains the patient pool but positions entrectinib within the niche of targeted therapies for genetically defined tumors.
Competitive Landscape
Key competitors include:
- Larotrectinib (Vitrakvi): First approved NTRK inhibitor, launched in 2018.
- Entrectinib: Differentiates by CNS penetration and broader kinase target profile.
- Crizotinib (Xalkori): Targets ROS1-positive NSCLC, replaced by more selective inhibitors but still relevant.
- Selpercatinib (Retevmo), Pralsetinib (Gavreto): Target RET fusions with rapid uptake.
Market Penetration Trends
Entrectinib's sales have been driven by expanded indications, with initial sales modest and expected growth as diagnostic testing becomes more widespread.
| Year |
US Sales (USD Million) |
Growth Rate |
Approximate Market Share |
Source |
| 2020 |
$80 million |
- |
30% (targeted therapies segment) |
[6] |
| 2021 |
$150 million |
+87.5% |
35% |
[6] |
| 2022 |
$200 million |
+33% |
40% |
[7] |
Price Projections
Current Pricing
The average wholesale price (AWP) for entrectinib is approximately $13,000 per month. A typical dosing regimen involves 600 mg daily divided into two doses.
| Parameter |
Value |
Source |
| Monthly cost |
~$13,000 |
[8] |
| Annual treatment cost |
~$156,000 |
- |
Factors Influencing Price Trends
- Manufacturing costs: Use of proprietary kinase inhibitors with complex synthesis.
- Market exclusivity: Patent protections extend into the late 2020s, limiting generic competition.
- Regulatory environment: Breakthrough therapy designation adds urgency but can impact payer negotiations.
- Expanded indications: Broader approval could justify price increases, especially for pediatric uses.
Future Price Trends
Pharmaceutical pricing may face downward pressure due to:
- Market competition: Entry of new, more selective inhibitors like selpercatinib and pralsetinib.
- Healthcare policy: Focus on drug price transparency may influence negotiated prices.
- Market penetration: As diagnostic testing becomes routine, increased market access could drive volume growth.
Projections indicate that the monthly price for entrectinib could decrease by 10-15% over the next 3–5 years, stabilizing around $10,500–$11,500 per month due to generics and new competitors.
Revenue Forecasts (US Market)
| Year |
Estimated Sales (USD Million) |
Assumptions |
Source |
| 2023 |
$250 million |
Steady market share, increased diagnostic testing |
[8], estimates based on current pricing and patient numbers |
| 2024 |
$280 million |
Slight price decrease, expanded indications |
|
| 2025 |
$310 million |
Market saturation, increased competition |
|
Global Market Outlook
Growth outside the US remains steady, especially in Europe, where reimbursement and access align with US trends. Emerging markets present opportunity but face barriers like pricing and regulatory approval delays.
Key Takeaways
- Market: Niche oncology therapy targeting genetically defined tumors, with an estimated US market of $250–$310 million annually.
- Competitive Edge: CNS penetration and broader kinase inhibition distinguish entrectinib from competitors.
- Pricing: Current prices around $13,000/month, with potential declines due to competition and policy shifts.
- Growth Drivers: Increase in diagnostic testing, expanded indications, and global adoption.
FAQs
Q1. What factors could accelerate entrectinib market growth?
Expansion of indications, increased companion diagnostic testing, and approvals in additional regions.
Q2. How does entrectinib compare in price to competitors?
It is priced similarly to larotrectinib, with current monthly prices around $13,000.
Q3. What is the patent status for entrectinib?
Patent protection extends into the late 2020s, delaying generic entry.
Q4. Are there opportunities for combination therapies involving entrectinib?
Yes, ongoing trials explore combinations with immune checkpoint inhibitors and other targeted agents.
Q5. How will healthcare policies impact entrectinib pricing?
Price negotiation pressures and stricter reimbursement policies could lead to price reductions.
References
- Grand View Research. (2022). Oncology Drugs Market Size, Share & Trends Analysis.
- Roberts, R., et al. (2016). NTRK gene fusions in cancer. NEJM, 375(24), 2390-2394.
- Drilon, A., et al. (2018). Targeting NTRK fusions in cancer. Nature Reviews Clinical Oncology, 15(12), 731-747.
- C.E. et al. (2020). RET fusion-positive NSCLC epidemiology. Cancer Epidemiology, 65, 101696.
- Domino, M.E., et al. (2021). ROS1-positive NSCLC characteristics. J Thorac Oncol, 16(9), 1452–1460.
- EvaluatePharma. (2021). Oncology drug sales data.
- IQVIA. (2022). US Oncology Market Trends.
- Manufacturer pricing reports, 2022.
