What Vizimpro is?
VIZIMPRO is an oral, once-daily, irreversible pan-human epidermal growth factor receptor kinase inhibitor. VIZIMPRO is approved in the EU 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.
VIZIMPRO is also approved in the United States for the first-line treatment of patients with metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test. Additionally, VIZIMPRO is approved in Japan for EGFR gene mutation-positive, inoperable or recurrent NSCLC, and in Canada for the first-line treatment of adult patients with unresectable locally advanced or metastatic NSCLC with confirmed EGFR exon 19 deletion or exon 21 L858R substitution mutations. The applications in the US and Japan were reviewed and approved under the Priority Review program.
What dacomitinib is?
Dacomitinib (trade name Vizimpro) is a drug candidate under development by Pfizer for the treatment of non-small-cell lung carcinoma (NSCLC). It is a selective and irreversible inhibitor of EGFR. Dacomitinib has advanced to several Phase III clinical trials.[when?] The January 2014 results of the first trials were disappointing, with a failure to meet the study goals. Additional Phase III trials are ongoing[when?].
In 2017, results of a trial comparing dacomitinib to gefitinib for NSCLC (driven by mutated EGFR) were announced. Dacomitinib was approved in the United States in 2018, in Japan in 2019 and in the European Union (EU) authorized by the European Medicines Agency (EMA) in 2019 for the treatment of non-small cell lung cancer with EGFR gene mutation.