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LIVE BLOG: New Skies for Advanced Local Basal Cell Carcinoma [Product Theater: Genentech]

In this Live Blog from the SDPA Summer Conference, an MD representing Genentech presents on Erivedge as Novel Therapy for Appropriate Patients with Basal Cell Carcinoma.  Erivedge is the 1st and only Hedgehog Pathway inhibitor approved by the FDA.

 

Erivedge is for patients who aren’t candidates for surgery, or who failed previous therapy.

 

Boxed Warnings / Adverse Reactions of Advanced BCC Patients

+ Embryo-Fetal Death and Severe Birth Defects

+ Advise both male and female patients of the potential risks

Spermacidal Contraception is recommended:

Women: 7 months after stopping the drop.

Men: 2 months

+ There is even risk concern for women who hope to get pregnant in the near future

 

+ Typically mild GI side-effects 

+ Fatigue, but functional (grade 1 or grade 2)

+ Weight loss (unclear if this is a primary product of the meds, or due to GI issues)

+ Taste Disorders

+ Muscle Spasms (if this happens, suggest taking a “drug holiday” for a few days)

 

The Hedgehog Pathway in BCC

1. The normal Hedgehog signaling – plays a crucial role in embryonic development.

2. Why is this pathway important in BCC?  

More than 90% of BCC have either:

+ Inactiviating mutations in PTCH

+ Activating mutations in SMO

 

There are 2 proteins involved:

One is patched, one is smoothing.  When patch binds to smoothing, you don’t have cell replications.  In most BCC we have a patched issue.

 

GLI translocates to the nucleus and turns on gene transcription.

 

Erivedge Proposed Mechanism of Action:

The following conclusions are based on preclinical data:

E inhibits the Hedgehog pathway by helping turn off cell replication

 

FACT:

+ BCC is the Most Common Cancer in Humans

+ About 3M will be diagnosed in the US this year.

 

The vast majority of Basal Cells will be treated through surgery, destruction, sometimes with just topical therapy.  But, uncommonly, the Basal Cell will “get away from us” in traditional therapies.  That’s when we need to think of other 

 

What is a locally advanced BCC?  

For a lot of cancers, the staging is well-definied. E.g. Melanoma patients – You gain tons of info on the cancer from the pathology report.  But if you just biopsy a basal carcinoma, until you look at the patient, you don’t get that much more info.  

 

Genentech is working to find out: What is a locally-advanced BCC?

 

Progression to Metastatic BCC is very Rare

In the Derm world, once it gets to this stage, we don’t typically manage it.

Prior to Erivedge approval, there were no FDA-approved oral therapies for locally advanced or metastatic BCC.

 

In Clinical Trials for Erivedge:

1. The trial was almost elegant, it was so simple:

a. We looked at a cancer

b. We measured it

c. We gave the drug

d. We showed how it had shrunk.

 

Tumor would have to shrink 30% or more for the drug to be considered  “a responder.”

 

Prior-Therapies in the Efficacy-Evaluable Population

1. The vast majority of the trial patients had prior therapy.

2. Having basal cell nevus syndrome was not enough to get you into the trial.  20% of them happened to have basal cell nevus syndrome, though.

 

What was the response rate with Erivedge?  43%!

 

What is the Dosing?

a. 1 Capsule per day (150mg) with/without food

b. Do not crush the capsules – the issue is over concern over who will be crushing them: e.g. Pregnant woman crushes pills for grandpa, this creates drug exposure for her

c. Can take a drug holiday for side effects

 

Inclusion Criteria Includes:

+ BCC size gretater than 10 mm in diameter

 

Erivedge is only distributed through select specialty pharmacies.  This is not a “one visit” drug.  Access Solutionis can help expedite the prescription process.

 

FACT:

Studies show that patients only retain about 20% of what we tell them in our office visits!  

 

 

[Image by Kevin Dooley]




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