EGFR L858R/T790M
EGFR/PI3K/AKT
Third-generation EGFR tyrosine kinase inhibitor designed to selectively target T790M resistance mutations while sparing wild-type EGFR, reducing skin and GI toxicity.
2.5 nM
180 nM
Targeting second-line treatment after first-generation EGFR TKI failure
Fast-track pathway with potential for accelerated approval based on ORR endpoint
3.5 years
3rd-gen EGFR TKI
EGFR T790M
$5.4B
45K
Approved 2015
3rd-gen EGFR TKI
EGFR T790M
$1.2B
12K
Phase III
3rd-gen EGFR TKI
EGFR T790M
$800M
8K
Approved China
Pan-HER TKI
EGFR/HER2
TBD
TBD
Phase II
$2.51B
Peak Sales Estimate
8.2%
CAGR
8-12%
CAGR
27%
Peak Share
6-12 mo
3-6 mo
12-24 mo
| Drug | Annual Price | Indication | Access Level |
|---|---|---|---|
| Osimertinib | $165K | EGFR+ NSCLC | Broad |
| Alectinib | $155K | ALK+ NSCLC | Broad |
| Lorlatinib | $195K | ALK+ NSCLC | Limited |
| Selpercatinib | $175K | RET+ NSCLC | Moderate |
85%
Rare Disease Eligibility
45%
PRV Eligibility
High
National Priority
10-12 mo
Review Timeline
$3M PDUFA fee waiver
7 years
$100-350M
N/A
Expedited review
N/A
Rolling review
N/A
$100-350M
PRV Sale Value
Based on recent market transactions
~30%
Licensing Premium
Revenue uplift from regulatory advantages
7 years
Market Exclusivity
Extended protection period
Years to Expiration
6
Exclusivity Years
45%
Generic Entry Risk
Strong
Core IP Position
Core compound structure and key analogs
Treatment methods for EGFR+ NSCLC
Tablet formulation and manufacturing process
Combination with checkpoint inhibitors
2024
Current position
2029
Composition of Matter
2030
Method of Use
2028
Formulation
2031
Combination
File additional patents on new formulations and combinations
Protect manufacturing processes and know-how
Leverage orphan drug and data exclusivity periods
Cross-licensing agreements with complementary IP
$3.826B
Peak Revenue
2030
$25.654B
Total 10-Year Revenue
2024-2033
17.1%
Peak Market Share
2030
26K
Peak Patients
2030
$156K
Avg Selling Price
Blended global
85%
Persistence Rate
12-month
18 mo
Treatment Duration
Median
60% US / 40% Ex-US
Geographic Split
Peak year
$8.2B
ANPV (8% discount)
3.2x
Peak Sales Multiple
Strong licensing position driven by differentiated efficacy profile, reasonable exclusivity window, and favorable market dynamics. Premium valuation expected in competitive process.
18/25
FDA Designations
15/20
Guidance Documents
12/20
Policy Incentives
14/15
Advocacy Activity
8/20
Market Precedent
Breakthrough Therapy
Likely
Fast Track
Eligible
Orphan Drug
Eligible
Priority Review
Potential
Oncology Endpoints
Aligned
Biomarker Strategy
Compliant
Real-World Evidence
Supportive
Patient-Reported Outcomes
Included
ARPA-H Funding
Potential
Medicare Innovation
Aligned
IRA Exclusions
Eligible
Tax Credits
Available
Patient Organizations
Strong
KOL Support
Established
Medical Societies
Engaged
Congressional Interest
Moderate
Similar Approvals
Limited
Pricing Precedent
Established
Access Patterns
Favorable
Competitive Response
Predictable
Clear FDA guidance reduces development risk and timeline uncertainty
Legislative incentives provide financial benefits and competitive advantages
Established payer acceptance patterns reduce commercial risk
Strong patient advocacy creates favorable environment for approval and access