FDA Approved Drugs » 2012
Medical Areas: Dermatology | Oncology | Family Medicine
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved January 2012
Treatment Area: basal cell carcinoma
Erivedge (vismodegib) is an inhibitor of the hedgehog (Hh) signaling pathway. The pathway promotes cellular development and division in several cell types, both through direct cellular activation and through secondary activation of multiple pathways of tissue generation, including angiogenesis and tissue growth. The pathway is typically over-activated in basal cell carcinoma.
Erivedge is specifically approved 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.
Erivedge is supplied as a tablet for oral administration. The recommended initial dose of Erivedge is 150 mg taken orally once daily until disease progression or until unacceptable toxicity. If a dose of Erivedge is missed, do not make up that dose; resume dosing with the next scheduled dose.
FDA ApprovalThe FDA approval of Erivedge was based on an international, single-arm, multi-center, open-label, two-cohort trial. The trial enrolled 104 subjects with either metastatic basal cell carcinoma (mBCC) or locally advanced BCC (laBCC). The subjects received 150 mg vismodegib per day orally until disease progression or unacceptable toxicity. The median duration of treatment was 10.2 months. The major efficacy outcome measure of the trial was objective response rate (ORR). In the mBCC cohort, tumor response was assessed according to RECIST criteria. In the laBCC cohort, tumor response evaluation included measurement of externally assessable tumor (including scar) and assessment for ulceration in photographs, radiographic assessment of target lesions (if appropriate), and tumor biopsy. Of the 104 subjects enrolled, 96 were evaluable for ORR. In the mBCC cohort, 30.3% reported an ORR and in the laBCC cohort 42.9% reported an ORR. The median response duration in both arms was 7.6 months.
Adverse events associated with the use of Erivedge may include, but are not limited to, the following:
Erivedge (vismodegib) is an inhibitor of the hedgehog (Hh) signaling pathway. Vismodegib binds to and inhibits Smoothened, a transmembrane protein involved in Hedgehog signal transduction. The Hh pathway promotes cellular development and division in several cell types, both through direct cellular activation and through secondary acivation of multiple pathways of tissue generation, including angiogenesis and tissue growth. The pathway is typically over-activated in basal cell carcinoma through downregulation of Hedgehog inhibition.
Amin SH, Tibes R, Kim JE, Hybarger CP Hedgehog antagonist GDC-0449 is effective in the treatment of advanced basal cell carcinoma. The Laryngoscope 2010 Dec;120(12):2456-9. doi: 10.1002/lary.21145
Von Hoff DD, LoRusso PM, Rudin CM, Reddy JC, Yauch RL, Tibes R, Weiss GJ, Borad MJ, Hann CL, Brahmer JR, Mackey HM, Lum BL, Darbonne WC, Marsters JC Jr, de Sauvage FJ, Low JA Inhibition of the hedgehog pathway in advanced basal-cell carcinoma. The New England Journal of Medicine 2009 Sep 17;361(12):1164-72
For additional information regarding Erivedge or basal cell carcinoma, please visit the Genentech products web page.