Vizimpro (dacomitinib)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved September 2018

Specific Treatments:

metastatic non-small cell lung cancer

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General Information

Vizimpro (dacomitinib) is a kinase inhibitor. 

Vizimpro is specifically indicated for the first-line treatment of patients with metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.

Vizimpro is supplied as a tablet for oral administration. The recommended dose is 45 mg taken orally once daily, until disease progression or unacceptable toxicity occurs. Vizimpro can be taken with or without food and should be administered at the same time each day. If the patient vomits or misses a dose, do not take an additional dose or make up a missed dose but continue with the next scheduled dose. 

Clinical Results

FDA Approval

The FDA approval of Vizimpro was based on the randomized, multicenter, open-label, active controlled ARCHER 1050 trial comparing the safety and efficacy of dacomitinib to gefitinib in 452 patients with unresectable, metastatic NSCLC. Patients were required to have had no prior therapy for metastatic or recurrent disease, with a minimum of 12 months disease-free after completion of systemic non-EGFR tyrosine kinase inhibitor–containing therapy; an Eastern Cooperative Oncology Group performance status of 0 or 1; and EGFR exon 19 deletion or exon 21 L858R substitution mutations. Patients were randomized (1:1) to receive either dacomitinib at 45 mg orally once daily or gefitinib at 250 mg orally once daily until disease progression or unacceptable toxicity. The trial demonstrated a significant improvement in progression-free survival. As determined by an independent review committee, the median progression-free survival was 14.7 and 9.2 months in the dacomitinib and gefitinib arms, respectively. 

Side Effects

Adverse effects associated with the use of Vizimpro may include, but are not limited to, the following:

diarrhea

rash

paronychia

stomatitis

decreased appetite

dry skin,

decreased weight

alopecia

cough

pruritus

Mechanism of Action

Vizimpro (dacomitinib )is an irreversible inhibitor of the kinase activity of the human EGFR family (EGFR/HER1, HER2, and HER4) and certain EGFR activating mutations (exon 19 deletion or the exon 21 L858R substitution mutation). In vitro dacomitinib also inhibited the activity of DDR1, EPHA6, LCK, DDR2, and MNK1 at clinically relevant concentrations.

Additional Information

For additional information regarding Vizimpro or metastatic non-small cell lung cancer, please visit https://www.vizimpro.com/