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Nodular and infiltrative BCC on cheek1

Stuart, a 59-year-old partial responder from the ERIVANCE trial

Learn more about Erivedge: ERIVANCE Trial Design, Erivedge Side Effects & Tips

Left cheek: Nodular and infiltrative BCC

Baseline Baseline basal cell carcinoma lesion on cheek of patient treated with Erivedge
Week 24 Basal cell carcinoma lesion on cheek after 24 weeks of treatment with Erivedge
Baseline basal cell carcinoma lesion on cheek of patient treated with Erivedge
Baseline
Week 8
Week 16
Basal cell carcinoma lesion on cheek after 24 weeks of treatment with Erivedge
Week 24

Patient details

Stuart's history of BCC

  • Stuart was initially diagnosed with BCC in 1999
  • In 1999, he underwent lesion excision in an unspecified location

Reasons why Stuart was eligible for treatment with Erivedge

  • Surgery was medically contraindicated because of anticipated substantial morbidity and/or deformity
  • Radiotherapy was considered contraindicated because of suspected Gorlin syndrome

Treatment

  • Stuart started treatment with Erivedge in December 2009 and was treated for 11.2 months
    • In the ERIVANCE trial, the median duration of treatment was 10.2 months (range, 0.7 to 18.7 months), inclusive of locally advanced BCC and metastatic BCC cohorts5
  • He discontinued therapy in November 2010 as a result of an adverse event unrelated to treatment with Erivedge

Clinical outcome

  • Stuart experienced a partial response, as assessed by independent review
    • Partial response is defined as objective response with presence of residual BCC on sampling biopsy
  • At Week 24, sampling biopsy did not show evidence of BCC
    • Partial response in this case was based on MRI findings, as assessed by RECIST*

Treatment-related adverse reactions

  • Stuart experienced alopecia, dysgeusia, and muscle spasms
    • In the ERIVANCE trial, the most common adverse reactions (≥10%) were muscle spasms, alopecia, dysgeusia, weight loss, fatigue, nausea, diarrhea, decreased appetite, constipation, arthralgias, vomiting, and ageusia5

ERIVANCE patient eligibility is based on study investigator assessment. Case study shows results of treatment in a specific patient and 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.

*Response Evaluation Criteria in Solid Tumors.

NEXT: All Cheek Lesion Studies

Indication and Important Safety Information

Indication

Erivedge 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.

Important Safety Information

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 the pregnancy status of females of reproductive potential within 7 days prior to initiating Erivedge. Advise pregnant women of the potential risks to a fetus. Advise females of reproductive potential to use effective contraception during and after Erivedge
  • 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
Warnings and Precautions
 
Embryo-Fetal Toxicity
  • Females of Reproductive Potential: Use contraception during therapy with Erivedge and for 24 months after the final dose
  • Males: Use condoms, even after a vasectomy, to avoid potential drug exposure in pregnant partners and female partners of reproductive potential during and for 3 months after the final dose of Erivedge. Do not donate semen during 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
  • 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
Severe Cutaneous Adverse Reactions
  • Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, have been reported during treatment with Erivedge. Permanently discontinue Erivedge in patients with these reactions
Musculoskeletal Adverse Reactions
  • Musculoskeletal adverse reactions, which may be accompanied by serum creatine phosphokinase (CPK) elevations, have occurred with Erivedge and other drugs which inhibit the hedgehog (Hh) pathway. In the pooled safety population in clinical trials of Erivedge, musculoskeletal and connective tissue adverse reactions occurred in 78% of patients treated, with 7% (9/138) reported as Grade 3. The most frequent manifestations of musculoskeletal and connective tissue adverse reactions (all grades) reported were muscle spasms (72%) and arthralgias (16%). In a post-approval clinical trial of 1232 patients, Grade 3 or 4 elevations in serum CPK laboratory values occurred in 2.4% of the 453 patients who had any CPK measurement
  • Obtain baseline serum creatine phosphokinase (CPK) and creatinine levels and as clinically indicated (e.g., if muscle symptoms are reported). Depending on the severity of symptoms, temporary dose interruption or discontinuation may be required for musculoskeletal adverse reactions or serum CPK elevation
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. Erivedge is not indicated for pediatric patients

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, 30% of 10 pre-menopausal women developed amenorrhea while receiving Erivedge
  • Grade 3 laboratory abnormalities observed in clinical trials were hyponatremia (4%), azotemia (2%), and hypokalemia (1%)
  • 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 blood creatine phosphokinase (CPK) reported. Within the subset of patients, 38% had a shift from baseline, including Grade 3 (3%) increased CPK. Grade 3 or 4 increased CPK occurred in 2.4% of the 453 patients across the entire study population with any CPK measurement
  • Adverse reactions identified during post-approval use: drug-induced liver injury, Stevens-Johnson syndrome/toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms

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 child, or the effects of the drug on milk production. Advise women 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, for a complete discussion of the risks associated with Erivedge.

    • Data on file. Genentech, Inc.

      Data on file. Genentech, Inc.

    • FDA approves Erivedge (vismodegib) capsule, the first medicine for adults with advanced basal cell carcinoma [press release]. San Francisco, CA: Genentech, Inc.; January 30, 2012.

      FDA approves Erivedge (vismodegib) capsule, the first medicine for adults with advanced basal cell carcinoma [press release]. San Francisco, CA: Genentech, Inc.; January 30, 2012.

    • Epstein EH. Basal cell carcinomas: attack of the hedgehog. Nat Rev Cancer. 2008;8(10):743-754.

      Epstein EH. Basal cell carcinomas: attack of the hedgehog. Nat Rev Cancer. 2008;8(10):743-754.

    • Scales SJ, de Sauvage FJ. Mechanisms of Hedgehog pathway activation in cancer and implications for therapy. Trends Pharmacol Sci. 2009;30(6):303-312.

      Scales SJ, de Sauvage FJ. Mechanisms of Hedgehog pathway activation in cancer and implications for therapy. Trends Pharmacol Sci. 2009;30(6):303-312.

    • Erivedge® (vismodegib) capsule Prescribing Information. Genentech, Inc. March 2023.

      Erivedge® (vismodegib) capsule Prescribing Information. Genentech, Inc. March 2023.

    • Sekulic A, Migden MR, Oro AE, et al. Efficacy and safety of vismodegib in advanced basal-cell carcinoma. N Engl J Med. 2012;366(23):2171-2179.

      Sekulic A, Migden MR, Oro AE, et al. Efficacy and safety of vismodegib in advanced basal-cell carcinoma. N Engl J Med. 2012;366(23):2171-2179.

    • Von Hoff DD, LoRusso PM, Rudin CM, et al. Inhibition of the hedgehog pathway in advanced basal-cell carcinoma. N Engl J Med. 2009;361(12):1164-1172.

      Von Hoff DD, LoRusso PM, Rudin CM, et al. Inhibition of the hedgehog pathway in advanced basal-cell carcinoma. N Engl J Med. 2009;361(12):1164-1172.

    • LoRusso PM, Rudin CM, Reddy JC, et al. Phase I trial of hedgehog pathway inhibitor vismodegib (GDC-0449) in patients with refractory, locally advanced or metastatic solid tumors. Clin Cancer Res. 2011;17(8):2502-2511.

      LoRusso PM, Rudin CM, Reddy JC, et al. Phase I trial of hedgehog pathway inhibitor vismodegib (GDC-0449) in patients with refractory, locally advanced or metastatic solid tumors. Clin Cancer Res. 2011;17(8):2502-2511.

    • Gupta S, Takebe N, LoRusso P. Targeting the hedgehog pathway in cancer. Ther Adv Med Oncol. 2010;2(4):237-250.

      Gupta S, Takebe N, LoRusso P. Targeting the hedgehog pathway in cancer. Ther Adv Med Oncol. 2010;2(4):237-250.

    • Cancer.org. How Targeted Therapies Are Used to Treat Cancer. https://www.cancer.org/treatment/treatments-and-side-effects/treatment-types/targeted-therapy/what-is.html. Accessed April 26, 2022.

      Cancer.org. How Targeted Therapies Are Used to Treat Cancer. https://www.cancer.org/treatment/treatments-and-side-effects/treatment-types/targeted-therapy/what-is.html. Accessed April 26, 2022.

    • Lear JT, Corner C, Dziewulski P, et al. Challenges and new horizons in the management of advanced basal cell carcinoma: a UK perspective. Br J Cancer. 2014;111(8):1476-1481.

      Lear JT, Corner C, Dziewulski P, et al. Challenges and new horizons in the management of advanced basal cell carcinoma: a UK perspective. Br J Cancer. 2014;111(8):1476-1481.

    • Ibrahim SF. Advanced basal cell carcinoma: treatment overview. The Dermatologist. 2014;22(3). https://www.hmpgloballearningnetwork.com/site/thederm/site/cathlab/event/advamced-basa-cell-carcinoma-treatment-overview. Published March 10, 2014. Accessed February 24, 2023.

      Ibrahim SF. Advanced basal cell carcinoma: treatment overview. The Dermatologist. 2014;22(3). https://www.hmpgloballearningnetwork.com/site/thederm/site/cathlab/event/advamced-basa-cell-carcinoma-treatment-overview. Published March 10, 2014. Accessed February 24, 2023.

    • Levine A, Markowitz O. Update on advanced basal cell carcinoma diagnosis and treatment. Dermatology Times. https://www.dermatologytimes.com/view/update-advanced-basal-cell-carcinoma-diagnosis-and-treatment. Accessed March 29, 2023.

      Levine A, Markowitz O. Update on advanced basal cell carcinoma diagnosis and treatment. Dermatology Times. https://www.dermatologytimes.com/view/update-advanced-basal-cell-carcinoma-diagnosis-and-treatment. Accessed March 29, 2023.

    • Amin SP, Russell KJ. Diagnosing, managing aBCC in elderly patients. Dermatology Times. https://www.dermatologytimes.com/view/diagnosing-managing-abcc-elderly-patients. Accessed March 29, 2023.

      Amin SP, Russell KJ. Diagnosing, managing aBCC in elderly patients. Dermatology Times. https://www.dermatologytimes.com/view/diagnosing-managing-abcc-elderly-patients. Accessed March 29, 2023.

    • Erivedge® (vismodegib) capsule European Medicines Agency Assessment Report. September 15, 2016.

      Erivedge® (vismodegib) capsule European Medicines Agency Assessment Report. September 15, 2016.

    • Lacouture ME, Dréno B, Ascierto PA, et al. Characterization and management of hedgehog pathway inhibitor-related adverse events in patients with advanced basal cell carcinoma. Oncologist. 2016;21(10):1218-1229.

      Lacouture ME, Dréno B, Ascierto PA, et al. Characterization and management of hedgehog pathway inhibitor-related adverse events in patients with advanced basal cell carcinoma. Oncologist. 2016;21(10):1218-1229.

    • National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE) v3.0. https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/ctcaev3.pdf. Accessed August 26, 2022.

      National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE) v3.0. https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/ctcaev3.pdf. Accessed August 26, 2022.

    • Solomon JA, Chever D, Iarrobino A, Caldwell C. Successful control of adverse events associated with vismodegib treatment of advanced basal cell carcinoma by recognition of hedgehog pathway activity in normal adult tissue. Poster presented at: International Investigative Dermatology Meeting; May 8-11, 2013; Edinburgh, Scotland, United Kingdom. Abstract 1088.

      Solomon JA, Chever D, Iarrobino A, Caldwell C. Successful control of adverse events associated with vismodegib treatment of advanced basal cell carcinoma by recognition of hedgehog pathway activity in normal adult tissue. Poster presented at: International Investigative Dermatology Meeting; May 8-11, 2013; Edinburgh, Scotland, United Kingdom. Abstract 1088.

    • Sekulic A, Migden MR, Lewis K, et al. Pivotal ERIVANCE basal cell carcinoma (BCC) study: 12-month update of efficacy and safety of vismodegib in advanced BCC. J Am Acad Dermatol. 2015;72(6):1021-1026.

      Sekulic A, Migden MR, Lewis K, et al. Pivotal ERIVANCE basal cell carcinoma (BCC) study: 12-month update of efficacy and safety of vismodegib in advanced BCC. J Am Acad Dermatol. 2015;72(6):1021-1026.

    • Fife K, Herd R, Lalondrelle S, et al. Managing adverse events associated with vismodegib in the treatment of basal cell carcinoma. Future Oncol. 2017;13(2):175-184.

      Fife K, Herd R, Lalondrelle S, et al. Managing adverse events associated with vismodegib in the treatment of basal cell carcinoma. Future Oncol. 2017;13(2):175-184.

    • Ibrahim SF. Treating advanced basal cell carcinoma. https://www.the-dermatologist.com/content/treating-advanced-basal-cell-carcinoma. Accessed April 26, 2022.

      Ibrahim SF. Treating advanced basal cell carcinoma. https://www.the-dermatologist.com/content/treating-advanced-basal-cell-carcinoma. Accessed April 26, 2022.

    • Le Moigne M, Saint-Jean M, Jirka A, et al. Dysgeusia and weight loss under treatment with vismodegib: benefit of nutritional management. Support Care Cancer. 2016;24(4):1689-1695.

      Le Moigne M, Saint-Jean M, Jirka A, et al. Dysgeusia and weight loss under treatment with vismodegib: benefit of nutritional management. Support Care Cancer. 2016;24(4):1689-1695.

    • Sekulic A, Migden MR, Basset-Séguin N, et al; for the ERIVANCE BCC Investigators. Long-term safety and efficacy of vismodegib in patients with advanced basal cell carcinoma: final update of the pivotal ERIVANCE BCC study. BMC Cancer. 2017;17(1):332. doi:10.1186/s12885-017-3286-5.

      Sekulic A, Migden MR, Basset-Séguin N, et al; for the ERIVANCE BCC Investigators. Long-term safety and efficacy of vismodegib in patients with advanced basal cell carcinoma: final update of the pivotal ERIVANCE BCC study. BMC Cancer. 2017;17(1):332. doi:10.1186/s12885-017-3286-5.

    • Mohan SV, Chang AL. Management of cutaneous and extracutaneous side effects of smoothened inhibitor therapy for advanced basal cell carcinoma. Clin Cancer Res. 2015;21(12):2677-2683.

      Mohan SV, Chang AL. Management of cutaneous and extracutaneous side effects of smoothened inhibitor therapy for advanced basal cell carcinoma. Clin Cancer Res. 2015;21(12):2677-2683.

    • American Society of Clinical Oncology. Appetite Loss. https://www.cancer.net/coping-with-cancer/physical-emotional-and-social-effects-cancer/managing-physical-side-effects/appetite-loss. Accessed April 26, 2022.

      American Society of Clinical Oncology. Appetite Loss. https://www.cancer.net/coping-with-cancer/physical-emotional-and-social-effects-cancer/managing-physical-side-effects/appetite-loss. Accessed April 26, 2022.

    • Basset-Séguin N, Hauschild A, Kunstfeld R, et al. Vismodegib in patients with advanced basal cell carcinoma: primary analysis of STEVIE, an international, open-label trial. Eur J Cancer. 2017;86:334-348.

      Basset-Séguin N, Hauschild A, Kunstfeld R, et al. Vismodegib in patients with advanced basal cell carcinoma: primary analysis of STEVIE, an international, open-label trial. Eur J Cancer. 2017;86:334-348.

    • Ozgur OK, Yin V, Chou E, et al. Hedgehog pathway inhibition for locally advanced periocular basal cell carcinoma and basal cell nevus syndrome. Am J Ophthalmol. 2015;160(2):220-227.e2. doi:10.1016/j.ajo.2015.04.040

      Ozgur OK, Yin V, Chou E, et al. Hedgehog pathway inhibition for locally advanced periocular basal cell carcinoma and basal cell nevus syndrome. Am J Ophthalmol. 2015;160(2):220-227.e2. doi:10.1016/j.ajo.2015.04.040

    • Clinicaltrials.gov. STEVIE: A Study of Vismodegib in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma. https://clinicaltrials.gov/ct2/show/NCT01367665. Accessed August 30, 2022.

      Clinicaltrials.gov. STEVIE: A Study of Vismodegib in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma. https://clinicaltrials.gov/ct2/show/NCT01367665. Accessed August 30, 2022.

    • National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE) v4.0. https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf. Accessed August 30, 2022.

      National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE) v4.0. https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf. Accessed August 30, 2022.

    • Erivedge® (vismodegib) capsule European Medicines Agency Assessment Report. September 15, 2016.

      Erivedge® (vismodegib) capsule European Medicines Agency Assessment Report. September 15, 2016.