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Case study

Case study. 46-year-old male with locally advanced BCC on the eyebrow and ear. F. Hoffman-La Roche Ltd. CH-4070 Basel Switzerland Date of preparation: May 2013 GL/ERIV/1305/0013s. Stable disease achieved.

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Case study

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  1. Case study 46-year-old male with locally advanced BCC on the eyebrow and ear F. Hoffman-La Roche Ltd. CH-4070 Basel Switzerland Date of preparation: May 2013 GL/ERIV/1305/0013s

  2. Stable disease achieved • Patient presented with multiple locally advanced basal cell carcinoma (BCC) lesions on the eyebrow and ear • Overall confirmed response to Erivedge® (vismodegib) by Independent Review Facility was stable disease • Permission must be obtained from the publisher before these images can be reproduced • Individual results may vary. Case studies show results of treatment in specific patients. Patients may have other lesions besides those depicted • 1. Sekulic A et al. N Engl J Med 2012;266:2171-2179; 2. EU MAA EMEA/H/C/2606, submission to EMA December 02, 2011; Roche; Hoffmann-La Roche Ltd. Baseline Week 24

  3. Patient history • Initially diagnosed with BCC in 1983 and underwent multiple prior surgeries • Baseline pathology determined nodular and infiltrative BCC • Not a candidate for surgery due to expected substantial morbidity/deformity • Not a candidate for radiotherapy due to risk of retinal damage and possible pre-existing diagnosis of Gorlin syndrome • Permission must be obtained from the publisher before these images can be reproduced • Individual results may vary. Case studies show results of treatment in specific patients. Patients may have other lesions besides those depicted • 1. Sekulic A et al. N Engl J Med 2012;266:2171-2179; 2. EU MAA EMEA/H/C/2606, submission to EMA December 02, 2011; Roche; Hoffmann-La Roche Ltd. Baseline

  4. Outcome • IRF assessment: stable disease • Week 24 • Sampling biopsy of eyebrow lesion found residual BCC • No BCC found in sampling biopsy of ear lesion • Week 72 • No ulceration or change in the lesions at last assessment before November 2010 data cut-off • Scar tissue was present • Patient continued on treatment • IRF, independent review facility • Permission must be obtained from the publisher before these images can be reproduced • Individual results may vary. Case studies show results of treatment in specific patients. Patients may have other lesions besides those depicted • 1. Sekulic A et al. N Engl J Med 2012;266:2171-2179; 2. EU MAA EMEA/H/C/2606, submission to EMA December 02, 2011; Roche; Hoffmann-La Roche Ltd. Week 24

  5. Erivedge® (vismodegib): Most common adverse events All treated patients (n=104) *These adverse events occurred in at least 20% of all patients and were coded with the use of the Medical Dictionary for Regulatory Activities (MedDRA), version 13.1. The highest grade of event is reported here for each patient. Data from primary analysis, 9 months after the first treatment of the last enrolled patient (November 26, 2010) Sekulic A et al. New Engl J Med 2012;366:2171-2179

  6. Erivedge® (vismodegib): Contraindications • Women of childbearing potential who do not comply with the Erivedge Pregnancy Prevention Programme • Women who are pregnant or breastfeeding • Coadministration of St John’s wort (Hypericum perforatum) • Hypersensitivity to the active substance or any of the excipients in Erivedge capsules • Erivedge (vismodegib) Summary of Product Characteristics. Roche. May 2013

  7. Erivedge® (vismodegib): Warnings and precautions • Erivedge exposure during pregnancy may cause embryo-foetal death or severe birth defects either from administration to a pregnant woman or through her exposure to semen from a male patient. It is important that you read the ‘Erivedge Pregnancy Prevention Programme: Information for Healthcare Providers Prescribing Erivedge’ brochure before prescribing Erivedge • For women of childbearing potential (WCBP) taking Erivedge • Ensure a medically supervised pregnancy test is taken within 7 days prior to starting Erivedge and monthly during treatment, even if the patient becomes amenorrhoeic • Ensure recommended contraception is always used while taking Erivedge and for 24 months after the final dose • Ensure WCBP do not breastfeed during treatment and 24 months after the final dose • For male patients taking Erivedge • Male patients taking Erivedge should always wear a condom (with spermicide, if available), even after a vasectomy, when having sex with a female partner while taking Erivedge and for 2 months after the final dose • Male patients should not donate semen during therapy and for 2 months after the final dose • Erivedge (vismodegib) Summary of Product Characteristics. Roche. May 2013

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