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FDA Approves Vismodegib (ERIVEDGE) for Basal Cell Carcinoma Treatment


This week brings announcement of a new medication for adults with metastatic basal cell carcinoma (BCC).  The US Food and Drug Administration (FDA) has approved the oral capsule vismodegib (ERIVEDGE) to treat adults in advanced stages of BCC, the first drug of its kind to be given approval for basal cell carcinoma.  The drug is intended for those with BCC recurring post-surgery, or for those who are not candidates for either surgery or radiation.


Today we examine a multi-clinic study which evaluated the drug for effectiveness and safety.


Quick Glance at the Study

+ 96 patients with BCC took part

+ Patients received 150 mg of vismodegib daily

+ 33 patients had metastatic BCC, 63 with locally advanced BCC

+ Median age was 62, 61% male

+ 97% of patients had been previously treated through surgery, radiotherapy or systemic therapy


Objective Response Rates

+ 33 patients with metastatic BCC had only partial responses to treatment

+ Of the 63 patients with locally advanced BCC, 14 had complete responses

+ Median duration was 7.6 months for both types of BCC


Side Effects of Vismodegib as Monotherapy for Metastatic BCC and Locally Advanced BCC Include:

Muscle spasms, weight loss, fatigue, nausea, diarrhea, alopecia, dysgeusia, decreased appetite, constipation, arthralgias, vomiting, and ageusia (occuring in more than 10% of patients).


Adverse Reactions Occurring in more than 1% of Patients Include: 

Weight loss, fatigue, muscle spasms, and decreased appetite.


Vismodegib and Pregnancy

It is very important for health care providers to understand and discuss the effects of vismodegib on the embryo/fetus.  Because the drug inhibits a crucial embryonic developmental pathway, it is important to verify pregancy in patients before the drug is prescribed. 


Sources: FDA, Medscape

[image by Tony the Misfit]


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