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Case study

Case study. 68-year-old male with metastatic BCC to lymph nodes and soft tissue. F. Hoffman-La Roche Ltd. CH-4070 Basel Switzerland Date of preparation: May 2013 GL/ERIV/1305/0013u. Partial response achieved.

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Case study

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  1. Case study 68-year-old male with metastatic BCC to lymph nodes and soft tissue F. Hoffman-La Roche Ltd. CH-4070 Basel Switzerland Date of preparation: May 2013 GL/ERIV/1305/0013u

  2. Partial response achieved • Previously presented with advanced basal cell carcinoma (BCC) on the left temple and left axillary lymph node and developed metastatic lesions in both lymph nodes and soft tissue several years later • Overall confirmed response to Erivedge® (vismodegib) by Independent Review Facility was partial response Right axillary lymph node • Baseline • Week 40 Images are not to be reproduced for commercial purposes Individual results may vary. Case studies show results of treatment in specific patients. Patients may have other lesions besides those depicted EU MAA EMEA/H/C/2606, submission to EMA December 02, 2011; Roche; Hoffmann-La Roche Ltd.

  3. Patient history • Initially diagnosed with BCC in 2007 and underwent Mohs surgery and biopsies of the left temple and left axillary lymph node • Metastasis to lymph nodes and soft tissue identified in 2009, and 2 target lesions selected using spiral CT scan • Existing conditions at baseline included alopecia, chronic pruritus, chronic tinnitus, Darier’s disease, left eye closure, vision loss in right eye, and partial hearing loss Right axillary lymph node Baseline Images are not to be reproduced for commercial purposes Individual results may vary. Case studies show results of treatment in specific patients. Patients may have other lesions besides those depicted EU MAA EMEA/H/C/2606, submission to EMA December 02, 2011; Roche; Hoffmann-La Roche Ltd.

  4. Outcome • IRF assessment: partial response • Week 48: • Patient continued to have partial response and remained on treatment at last assessment before the November 2010 data cut-off Right axillary lymph node Week 40 IRF, independent review facility Images are not to be reproduced for commercial purposes Individual results may vary. Case studies show results of treatment in specific patients. Patients may have other lesions besides those depicted EU MAA EMEA/H/C/2606, submission to EMA December 02, 2011; Roche; Hoffmann-La Roche Ltd.

  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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