Difference between revisions of "Dacomitinib (Vizimpro)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * | + | *2018-09-27: Initial approval for the first-line treatment of patients with metastatic [[Non-small_cell_lung_cancer|non-small cell lung cancer (NSCLC)]] with [[Biomarkers#EGFR|epidermal growth factor receptor (EGFR)]] [[Biomarkers#Exon_19|exon 19]] [[Biomarkers#Deletion|deletion]] or [[Biomarkers#L858R|exon 21 L858R substitution]] mutations. ''(Based on ARCHER 1050)'' |
| + | ==History of changes in EMA indication== | ||
| + | *2019-04-02: Initial authorization | ||
| + | *Uncertain date: Vizimpro, as monotherapy, is indicated for the first-line treatment of adult patients with locally advanced or metastatic [[Non-small_cell_lung_cancer|non small cell lung cancer (NSCLC)]] with epidermal growth factor receptor (EGFR) activating mutations. | ||
| + | ==History of changes in Health Canada indication== | ||
| + | *2019-02-26: Initial notice of compliance for the first-line treatment of adult patients with unresectable locally advanced or metastatic [[non-small cell lung cancer|non-small cell lung cancer (NSCLC)]] with confirmed epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations. | ||
| + | *2022-06-09: Drug withdrawn | ||
| + | ==History of changes in PMDA indication== | ||
| + | *2019-01-08: New approval for the treatment of inoperable or recurrent [[non-small cell lung cancer]] with EGFR gene mutation. | ||
| + | == Patient Drug Information== | ||
| + | *[https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211288s000lbl.pdf Dacomitinib (Vizimpro) Package Insert]<ref>[https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211288s000lbl.pdf Dacomitinib (Vizimpro) Package Insert]</ref> | ||
==Also known as== | ==Also known as== | ||
*'''Code name:''' PF-00299804 | *'''Code name:''' PF-00299804 | ||
*'''Brand name:''' Vizimpro | *'''Brand name:''' Vizimpro | ||
| + | |||
| + | ==References== | ||
[[Category:Drugs]] | [[Category:Drugs]] | ||
| Line 21: | Line 33: | ||
[[Category:Non-small cell lung cancer medications]] | [[Category:Non-small cell lung cancer medications]] | ||
[[Category:FDA approved in 2018]] | [[Category:FDA approved in 2018]] | ||
| + | [[Category:EMA approved in 2019]] | ||
| + | [[Category:Health Canada approved in 2019]] | ||
| + | [[Category:PMDA approved in 2019]] | ||
Latest revision as of 16:55, 15 June 2023
Mechanism of action
From the NCI Drug Dictionary: An orally bioavailable, highly selective, second-generation small-molecule inhibitor of the pan-epidermal growth factor receptor (EGFR) family of tyrosine kinases (ErbB family) with potential antineoplastic activity. Dacomitinib specifically and irreversibly binds to and inhibits human EGFR subtypes, resulting in inhibition of proliferation and induction of apoptosis in EGFR-expressing tumor cells.
Diseases for which it is approved
History of changes in FDA indication
- 2018-09-27: Initial approval for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations. (Based on ARCHER 1050)
History of changes in EMA indication
- 2019-04-02: Initial authorization
- Uncertain date: Vizimpro, as monotherapy, is indicated for the first-line treatment of adult patients with locally advanced or metastatic non small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) activating mutations.
History of changes in Health Canada indication
- 2019-02-26: Initial notice of compliance for the first-line treatment of adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) with confirmed epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations.
- 2022-06-09: Drug withdrawn
History of changes in PMDA indication
- 2019-01-08: New approval for the treatment of inoperable or recurrent non-small cell lung cancer with EGFR gene mutation.
Patient Drug Information
Also known as
- Code name: PF-00299804
- Brand name: Vizimpro