Partial responder: 82-year-old male with locally advanced BCC in multiple locations 2*†

Patient from pivotal ERIVANCE study.
To view detailed efficacy results, click here.

Scalp: Confirmed BCC

Scalp: N/A

Scalp: N/A

Scalp: Residual BCC present 

Right preauricular area: Confirmed BCC

Right preauricular area: N/A

Right preauricular area: N/A

Right preauricular area: No residual BCC

Neck: Confirmed BCC

Neck: N/A

Neck: N/A

Neck: No residual BCC present

Nose: Confirmed BCC

Nose: N/A

Nose: N/A

Nose: No residual BCC present

History

  • Initially diagnosed with BCC in 2001
  • Underwent multiple extensive procedures, including curettage and electrodesiccation on ear in 2003, Mohs surgery on multiple locations and multiple excisions in 2005, and multiple excisions in 2006

Why was this patient eligible for treatment with Erivedge?

  • Not a candidate for surgery due to recurrent BCC unlikely to be curatively resected and anticipated substantial morbidity and/or deformity
  • Not a candidate for radiotherapy due to extensive disease

Outcomes

  • Overall outcome was partial response, confirmed by Independent Review
    • Partial response was defined as objective response with presence of residual BCC on sampling biopsy at Week 24 13
    • At Week 24 biopsy, residual BCC was detected on scalp lesion and no BCC on remaining lesions
  • Treated with Erivedge for 8.4 months before discontinuing based on patient’s own decision
    • The median duration of treatment in the ERIVANCE trial was 10.2 months (range, 0.7 to 18.7 months) inclusive of the locally advanced BCC and metastatic BCC cohorts 4

Treatment-related adverse reactions

  • Muscle spasms, fatigue, nausea, alopecia, abdominal pain, decreased appetite, diarrhea, dysgeusia, vomiting, altered saliva, and flatulence

*Patient may have had target lesions besides those depicted.

ERIVANCE patient. Case study shows results of treatment in a specific patient, and the case was last verified at clinical data cutoff. Individual results may vary. This case is for general informational purposes only and is not intended to convey medical advice. You should use your independent medical judgment in the diagnosis and treatment of your patients.

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BOXED WARNING

Embryo-Fetal Toxicity

  • Erivedge can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. Erivedge is embryotoxic, fetotoxic, and teratogenic in animals. Teratogenic effects included severe midline defects, missing digits, and other irreversible malformations
  • Verify pregnancy status of females of reproductive potential within 7 days prior to initiating Erivedge therapy. Advise females of reproductive potential to use effective contraception during and after Erivedge therapy. Advise males of the potential risk of Erivedge exposure through semen and to use condoms with a pregnant partner or a female partner of reproductive potential. Advise pregnant women of the potential risks to a fetus

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INDICATION

Erivedge® (vismodegib) capsule is indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation.

BOXED WARNING AND ADDITIONAL IMPORTANT SAFETY INFORMATION

Embryo-Fetal Toxicity

  • Erivedge can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. Erivedge is embryotoxic, fetotoxic, and teratogenic in animals. Teratogenic effects included severe midline defects, missing digits, and other irreversible malformations
  • Verify pregnancy status of females of reproductive potential within 7 days prior to initiating Erivedge therapy. Advise females of reproductive potential to use effective contraception during and after Erivedge therapy. Advise males of the potential risk of Erivedge exposure through semen and to use condoms with a pregnant partner or a female partner of reproductive potential. Advise pregnant women of the potential risks to a fetus
  • Advise female patients and female partners of male patients to contact their healthcare provider with a known or suspected pregnancy. Report pregnancies to Genentech at (888) 835‑2555

Female Patients

  • Advise females of reproductive potential to use effective contraception during therapy with Erivedge and for 24 months after the final dose

Male Patients

  • Advise males of the potential risk to an embryo or fetus if a female partner of reproductive potential is exposed to Erivedge. Advise male patients to use condoms with a pregnant partner or a female partner of reproductive potential, even after a vasectomy, during therapy and for 3 months after the final dose of Erivedge

Blood Donation

  • Advise patients not to donate blood or blood products while receiving Erivedge and for 24 months after the final dose of Erivedge

Semen Donation

  • Vismodegib is present in semen. It is not known if the amount of vismodegib in semen can cause embryo-fetal harm. Advise male patients not to donate semen during and for 3 months after the final dose of Erivedge

Premature Fusion of the Epiphyses

  • Premature fusion of the epiphyses has been reported in pediatric patients exposed to Erivedge. In some cases, fusion progressed after drug discontinuation

Adverse Reactions

  • The most common adverse reactions (≥10%) were muscle spasms, alopecia, dysgeusia, weight loss, fatigue, nausea, diarrhea, decreased appetite, constipation, arthralgias, vomiting, and ageusia
  • Amenorrhea can occur in females of reproductive potential. Reversibility of amenorrhea is unknown. In clinical trials, a total of 3 of 10 pre-menopausal women developed amenorrhea while receiving Erivedge
  • Treatment-emergent Grade 3 laboratory abnormalities observed in clinical trials were hyponatremia in 6 patients (4%), hypokalemia in 2 patients (1%), and azotemia in 3 patients (2%)
  • Additionally, in a post-approval clinical trial conducted in 1232 patients with locally advanced or metastatic BCC treated with Erivedge, a subset of 29 patients had baseline values for CPK reported. Within the subset of patients, 38% had a shift from baseline, and one of the patients had a Grade 3 value. The prevalence of Grade 3/4 CPK elevation across the entire study population with any CPK measurement was 2.4% (11 out of 453 patients)

Use in Specific Populations

Lactation

  • No data are available regarding the presence of vismodegib in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. Because of the potential for serious adverse reactions in breastfed infants from Erivedge, advise a nursing woman that breastfeeding is not recommended during therapy with Erivedge and for 24 months after the final dose

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Please see full Prescribing Information, including the BOXED WARNING and the Medication Guide, for a complete discussion of the risks associated with Erivedge.