Section 3 of 6
Product information and disease description
57 evidence topics · 57 sources
Product description
Phase of product development
FDA acceptance date
Anticipated FDA action date
Special FDA designation: initial announcement
Special FDA designation: later historical description
Launch
No evidence found.
Product launch date and FDA Advisory Committee meeting
No evidence found.
Product information
Generic, brand name and therapeutic class of product
Dosage forms and strengths
Commercial dosage forms, strengths, storage, and handling
No evidence found.
Research reagent: not a clinical dosage form
Research reagent safety data sheet
| SDS information element | Direct quotation |
|---|---|
| Product name | “Zipalertinib” |
| Product catalogue number | “207108” |
| CAS number | “1661854-97-2” |
| Identified uses | “Laboratory chemicals, Synthesis of substances.” |
| Revision date | “5/20/2022” |
Investigational formulation in the adjuvant protocol
Average sales price and wholesale acquisition cost
Not applicable.
American hospital formulary service (AHFS), or other drug classification
Indication
Prior-treatment population in the application
Pharmacology
Mechanism of action
Proposed mechanism of action
Covalent binding site
Pharmacodynamics
Pharmacokinetics
Time to peak concentration after fasting administration
Contraindications/Warnings/Precautions/Adverse effects
Warnings and precautions
Not applicable.
Special populations
Renal and hepatic dose adjustments
No evidence found.
Drug/Drug, drug/disease interactions
Effects of other drugs on Zipalertinib
No evidence found.
Effects of Zipalertinib on other drugs
Dosing and administration
Dosage
Investigational monotherapy dosage
Administration
Food instructions in the updated trial presentation
Access and distribution
Pre-approval access: Taiho’s general expanded-access policy
Anticipated commercial distribution strategy and patient support programs
No evidence found.
Co-prescribed/Concomitant therapies
First-line combination studied in REZILIENT3
Effect of Zipalertinib on quality measures
No evidence found.
Product comparison
Place of product in therapy
Disease description
Definition and etiology
Epidemiology
Incidence of EGFR exon 20 insertion-mutated non-small-cell lung cancer
U.S. annual incidence per 100,000 for the anticipated indication
No evidence found.
Prevalence of EGFR exon 20 insertion-mutated non-small-cell lung cancer
U.S. population prevalence per 100,000 for the anticipated indication
No evidence found.
Natural history, survival, and mortality
Natural history: clinical characteristics and prognosis
Real-world outcomes: overall survival versus common EGFR mutations
Pathophysiology
Diagnosis
Guideline preference for multiplex molecular testing
Clinical presentation - signs and symptoms
Constitutional and pain symptoms in the exon 20 insertion population
Long-term morbidity
CNS involvement in the REZILIENT1 safety population, n (%)
Burden of EGFR exon 20 insertion-mutated non-small-cell lung cancer
Humanistic burden and health-related quality of life
Systematic literature review: scope of the burden evidence
Economic burden and healthcare resource utilization
Amivantamab treatment patterns and health care resource utilization
Amivantamab plus chemotherapy economic model
Economic impact of EGFR exon 20 insertion-mutated non-small-cell lung cancer on families
Not applicable.
Economic impact of diagnostic testing
No evidence found.
Approaches to treatment
Current treatment options and standard of care
EGFR-MET bispecific antibodies
Comparator regulatory information: amivantamab
First-line amivantamab plus chemotherapy: progression-free survival and response
First-line amivantamab plus chemotherapy: toxicity and treatment discontinuation
EGFR tyrosine kinase inhibitors
Comparator regulatory information: sunvozertinib
Treatment alternatives: sunvozertinib, WU-KONG1B
Treatment alternatives: first-line sunvozertinib, WU-KONG28
Cytotoxic chemotherapy
Platinum-pemetrexed backbone in the approved first-line combination
Surgery
Local therapy for selected oligometastatic disease
Radiotherapy
Local therapy for selected oligometastatic disease
Supportive and palliative care
Palliative care alongside oncologic treatment
Limitations of current therapies
Summary
Amivantamab with platinum-based chemotherapy is recommended for first-line treatment, and sunvozertinib has accelerated approval after platinum-based chemotherapy. Activity in one line of treatment does not establish comparative effectiveness in another. WU-KONG28 reported objective responses in 58.9% with sunvozertinib and 31.1% with chemotherapy. The evidence assembled here does not provide a randomized comparison of Zipalertinib against amivantamab-containing therapy or sunvozertinib.
Place in treatment, anticipated use, and care setting
Summary
The proposed post-platinum use includes participants previously treated with or without amivantamab. REZILIENT1 evaluates oral monotherapy, whereas REZILIENT3 evaluates first-line Zipalertinib with platinum-pemetrexed chemotherapy. These regimens and populations should be considered separately. Pre-approval access requests must come from physicians and do not guarantee access.
Heterogeneity of treatment effect
Zipalertinib clinical resistance case report
Diversity of exon 20 insertion variants
Care management intervention strategies
Guideline follow-up interval
Other product development or post-marketing obligations required by the FDA
Not applicable.
Ongoing post-approval monitoring
Not applicable.