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Drug Safety Evaluation

Efficacy and safety of sonidegib for the management of basal cell carcinoma: a drug safety evaluation

, , ORCID Icon, , , , , & ORCID Icon show all
Pages 525-531 | Received 06 Apr 2023, Accepted 15 Jun 2023, Published online: 20 Jun 2023

References

  • Verkouteren JAC, Ramdas KHR, Wakkee M, et al. Epidemiology of basal cell carcinoma: scholarly review. Br J Dermatol. 2017;177(2):359–372. doi: 10.1111/bjd.15321
  • Basset-Seguin N, Herms F. Update in the management of basal cell carcinoma. Acta Derm Venereol. 2020; 100(11):adv00140. doi: 10.2340/00015555-3495
  • Cameron MC, Lee E, Hibler BP, et al. Basal cell carcinoma: epidemiology; pathophysiology; clinical and histological subtypes; and disease associations. J Am Acad Dermatol. 2019;80(2):303–317. doi: 10.1016/j.jaad.2018.03.060
  • Kasumagic-Halilovic E, Hasic M, Ovcina-Kurtovic N. A Clinical Study of basal cell carcinoma. Med Arch (Sarajevo, Bosnia Herzegovina). 2019; 73(6):394–398. doi: 10.5455/medarh.2019.73.394-398
  • Peris K, Fargnoli MC, Garbe C, et al. Diagnosis and treatment of basal cell carcinoma: european consensus-based interdisciplinary guidelines. Eur J Cancer. 2019;118:10–34. doi: 10.1016/j.ejca.2019.06.003
  • Di Brizzi EV, Argenziano G, Brancaccio G, et al. The current clinical approach to difficult-to-treat basal cell carcinomas. Expert Rev Anticancer Ther. 2023;23(1):43–56. doi: 10.1080/14737140.2023.2161517
  • Villani A, Potestio L, Fabbrocini G, et al. Long-term efficacy of telemedicine for patients with locally advanced basal cell carcinoma during COVID-19 pandemic. Dermatol Ther. 2022;35(11): Published online August 2022:e15786. doi: 10.1111/dth.15786
  • Gutzmer R, Solomon JA. Hedgehog pathway inhibition for the treatment of basal cell carcinoma. Target Oncol. 2019; 14(3):253–267. doi: 10.1007/s11523-019-00648-2
  • Villani A, Potestio L, Fabbrocini G, et al. New Emerging Treatment options for advanced basal cell carcinoma and squamous cell carcinoma. Adv Ther. 2022;39(3):1164–1178. doi: 10.1007/s12325-022-02044-1
  • Villani A, Fabbrocini G, Costa C, et al. Sonidegib: safety and efficacy in treatment of advanced basal cell carcinoma. Dermatol Ther (Heidelb). 2020;10(3):401–412. doi: 10.1007/s13555-020-00378-8
  • Sonidegib. EMA approval. cited Mar 31, 2023. Available at: https://www.ema.europa.eu/en/documents/product-information/odomzo-epar-product-information_en.pdfLast
  • Amakye D, Jagani Z, Dorsch M. Unraveling the therapeutic potential of the Hedgehog pathway in cancer. Nat Med. 2013; 19(11):1410–1422. doi: 10.1038/nm.3389
  • Pak E, Segal RA. Hedgehog signal transduction: key players, oncogenic drivers, and cancer therapy. Dev Cell. 2016; 38(4):333–344. doi: 10.1016/j.devcel.2016.07.026
  • Rimkus TK, Carpenter RL, Qasem S, et al. Targeting the sonic hedgehog signaling pathway: review of smoothened and GLI inhibitors. Cancers (Basel). 2016;8(2):22. doi: 10.3390/cancers8020022
  • Sanmartín O, Llombart B, Carretero Hernández G, et al. Sonidegib in the treatment of locally advanced basal cell carcinoma. Actas Dermosifiliogr. 2021;112(4):295–301. doi: 10.1016/j.ad.2020.11.002
  • Ramelyte E, Amann VC, Dummer R. Sonidegib for the treatment of advanced basal cell carcinoma. Expert Opin Pharmacother. 2016;17(14):1963–1968. doi: 10.1080/14656566.2016.1225725
  • Zollinger M, Lozac’h F, Hurh E, et al. Absorption, distribution, metabolism, and excretion (ADME) of 14C-sonidegib (LDE225) in healthy volunteers. Cancer Chemother Pharmacol. 2014;74(1):63–75. doi: 10.1007/s00280-014-2468-y
  • Rodon J, Tawbi HA, Thomas AL, et al. A phase I, multicenter, open-label, first-in-human, dose-escalation study of the oral smoothened inhibitor Sonidegib (LDE225) in patients with advanced solid tumors. Clin Cancer Res An Off J Am Assoc Cancer Res. 2014;20(7):1900–1909. doi: 10.1158/1078-0432.CCR-13-1710
  • Pan S, Wu X, Jiang J, et al. Discovery of NVP-LDE225, a Potent and selective smoothened antagonist. ACS Med Chem Lett. 2010;1(3):130–134. doi: 10.1021/ml1000307
  • Dummer R, Ascierto PA, Basset-Seguin N, et al. Sonidegib and vismodegib in the treatment of patients with locally advanced basal cell carcinoma: a joint expert opinion. J Eur Acad Dermatol Venereol. 2020;34(9):1944–1956. doi: 10.1111/jdv.16230
  • Graham RA, Lum BL, Cheeti S, et al. Pharmacokinetics of hedgehog pathway inhibitor vismodegib (GDC-0449) in patients with locally advanced or metastatic solid tumors: the role of alpha-1-acid glycoprotein binding. Clin Cancer Res An Off J Am Assoc Cancer Res. 2011;17(8):2512–2520. doi: 10.1158/1078-0432.CCR-10-2736
  • Lorusso PM, Jimeno A, Dy G, et al. Pharmacokinetic dose-scheduling study of hedgehog pathway inhibitor vismodegib (GDC-0449) in patients with locally advanced or metastatic solid tumors. Clin Cancer Res An Off J Am Assoc Cancer Res. 2011;17(17):5774–5782. doi: 10.1158/1078-0432.CCR-11-0972
  • Odom D, Mladsi D, Purser M, et al. A matching-adjusted indirect comparison of sonidegib and vismodegib in advanced basal cell carcinoma. J Skin Cancer. 2017;2017:6121760. doi: 10.1155/2017/6121760
  • Goel V, Hurh E, Stein A, et al. Population pharmacokinetics of sonidegib (LDE225), an oral inhibitor of hedgehog pathway signaling, in healthy subjects and in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2016;77(4):745–755. doi: 10.1007/s00280-016-2982-1
  • Einolf HJ, Zhou J, Won C, et al. A Physiologically-Based Pharmacokinetic Modeling Approach to Predict Drug-Drug Interactions of sonidegib (LDE225) with perpetrators of CYP3A in cancer patients. Drug Metab Dispos. 2017;45(4):361–374. doi: 10.1124/dmd.116.073585
  • Migden MR, Guminski A, Gutzmer R, et al. Treatment with two different doses of sonidegib in patients with locally advanced or metastatic basal cell carcinoma (BOLT): a multicentre, randomised, double-blind phase 2 trial. Lancet Oncol. 2015;16(6):716–728. doi: 10.1016/S1470-2045(15)70100-2
  • Dummer R, Guminksi A, Gutzmer R, et al. Long-term efficacy and safety of sonidegib in patients with advanced basal cell carcinoma: 42-month analysis of the phase II randomized, double-blind BOLT study. Br J Dermatol. 2020;182(6):1369–1378. doi: 10.1111/bjd.18552
  • Lear JT, Migden MR, Lewis KD, et al. Long-term efficacy and safety of sonidegib in patients with locally advanced and metastatic basal cell carcinoma: 30-month analysis of the randomized phase 2 BOLT study. J Eur Acad Dermatol Venereol. 2018;32(3):372–381. doi: 10.1111/jdv.14542
  • Dummer R, Guminski A, Gutzmer R, et al. The 12-month analysis from basal cell carcinoma outcomes with LDE225 treatment (BOLT): a phase II, randomized, double-blind study of sonidegib in patients with advanced basal cell carcinoma. J Am Acad Dermatol. 2016;75(1):113–125.e5. doi: 10.1016/j.jaad.2016.02.1226
  • Villani A, Fabbrocini G, Costa C, et al. Sonidegib efficacy and tolerability in advanced basal cell carcinoma: a single-center real-life experience. J Am Acad Dermatol. 2022;86(4):e175. doi: 10.1016/j.jaad.2021.11.041
  • Villani A, Fabbrocini G, Scalvenzi M. Sonidegib treatment in patients with locally advanced basal cell carcinoma. Dermatol Ther. 2022;35(4):e15348. doi: 10.1111/dth.15348
  • Grossmann LE, Ramelyte E, Nägeli MC, et al. Eight years of real-life experience with smoothened inhibitors in a swiss tertiary skin referral center. Cancers (Basel). 2022;14(10):2496. doi: 10.3390/cancers14102496
  • Herms F, Baroudjian B, Delyon J, et al. Sonidegib in the treatment of locally advanced basal cell carcinoma: a retrospective study. Acta Derm Venereol. 2022;102:adv00740. doi: 10.2340/actadv.v102.1995
  • Toffoli L, Conforti C, Zelin E, et al. Locally advanced basal cell carcinoma: real-life data with sonidegib. Dermatol Ther. 2022;35(6):e15441. doi: 10.1111/dth.15441
  • Moscarella E, Brancaccio G, Briatico G, et al. Management of advanced basal cell carcinoma: real-life data with sonidegib. Dermatol Ther. 2021;34(3):e14948. doi: 10.1111/dth.14948
  • Villani A, Ocampo-Garza SS, Potestio L, et al. Cemiplimab for the treatment of advanced cutaneous squamous cell carcinoma. Expert Opin Drug Saf. 2022;21(1):21–29. doi: 10.1080/14740338.2022.1993819
  • Villani A, Scalvenzi M, Fabbrocini G, et al. Looking into a better future: novel therapies for metastatic melanoma. Dermatol Ther (Heidelb). 2021;11(3):751–767. doi: 10.1007/s13555-021-00525-9
  • Ahmed B, Qadir MI, Ghafoor S. Malignant melanoma: skin cancer-diagnosis, prevention, and treatment. Crit Rev Eukaryot Gene Expr. 2020;30(4):291–297. doi: 10.1615/CritRevEukaryotGeneExpr.2020028454
  • Villani A, Potestio L, Fabbrocini G, et al. The treatment of advanced melanoma: therapeutic update. Int J Mol Sci. 2022;23(12):6388. doi: 10.3390/ijms23126388
  • Marzuka AG, Book SE. Basal cell carcinoma: pathogenesis, epidemiology, clinical features, diagnosis, histopathology, and management. Yale J Biol Med. 2015;88(2):167–179.
  • Hernandez LE, Mohsin N, Levin N, et al. Basal cell carcinoma: an updated review of pathogenesis and treatment options. Dermatol Ther. 2022;35(6):e15501. doi: 10.1111/dth.15501
  • Kim JYS, Kozlow JH, Mittal B, et al. Guidelines of care for the management of basal cell carcinoma. J Am Acad Dermatol. 2018;78(3):540–559. doi: 10.1016/j.jaad.2017.10.006
  • Villani A, Megna M, Fabbrocini G, et al. Long-term efficacy of vismodegib after its withdrawal and patients’ health-related quality of life using the dermatology life quality index (DLQI). Dermatol Ther (Heidelb). 2019;9(4):719–724. doi: 10.1007/s13555-019-00323-4
  • Leavitt E, Lask G, Martin S. Sonic hedgehog pathway inhibition in the treatment of advanced basal cell carcinoma. Curr Treat Options Oncol. 2019;20(11):84. doi: 10.1007/s11864-019-0683-9
  • Villani A, Fabbrocini G, Costa C, et al. Expert opinion on sonidegib efficacy, safety and tolerability. Expert Opin Drug Saf. 2021;20(8):877–882. doi: 10.1080/14740338.2021.1921734
  • Alkeraye SS, Alhammad GA, Binkhonain FK. Vismodegib for basal cell carcinoma and beyond: what dermatologists need to know. Cutis. 2022;110(3):155–158. doi: 10.12788/cutis.0601
  • Scalvenzi M, Costa C, Cappello M, et al.; Reply to Woltsche N. Managing adverse effects by dose reduction during routine treatment of locally advanced basal cell carcinoma with the hedgehog inhibitor vismodegib: a single-centre experience. J Eur Acad Dermatol Venereol. 2019;33(4):e145–e147. doi: 10.1111/jdv.15469
  • 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. doi: 10.1056/NEJMoa1113713
  • Scalvenzi M, Villani A, Mazzella C, et al. Vismodegib treatment in a HIV positive patient on antiretroviral therapy. Indian J Dermatol Venereol Leprol. 2018;84(6):758–760. doi: 10.4103/ijdvl.IJDVL_92_18
  • Villani A, Scalvenzi M, Fabbrocini G, et al. Effects of COVID-19 pandemic on malignant melanoma diagnosis. J Eur Acad Dermatol Venereol. 2023;37(1):e22–e23. doi: 10.1111/jdv.18545
  • Trabelsi S, Khidher F. Rapid onset of response to sonidegib for multiple facial basal cell carcinomas during COVID-19 pandemic. Dermatol Ther. 2022;35(4):e15317. doi: 10.1111/dth.15317
  • Villani A, Fabbrocini G, Costa C, et al. Patients with advanced basal cell carcinomas in treatment with sonic hedgehog inhibitors during the coronavirus disease 2019 (COVID-19) period: management and adherence to treatment. J Am Acad Dermatol. 2020;82(6):e205. doi: 10.1016/j.jaad.2020.03.057
  • Villani A, Annunziata MC, Abategiovanni L, et al. Teledermatology for acne patients: how to reduce face-to-face visits during COVID-19 pandemic. J Cosmet Dermatol. 2020;19(8):1828. doi: 10.1111/jocd.13519
  • De Lucia M, Potestio L, Costanzo L, et al. Scabies outbreak during COVID-19: an Italian experience. Int J Dermatol. 2021;60(10):1307–1308. doi: 10.1111/ijd.15809
  • Megna M, Camela E, Villani A, et al. Teledermatology: a useful tool also after COVID-19 era? J Cosmet Dermatol. 2022; 21(6):2309–2310. doi: 10.1111/jocd.14938
  • Villani A, Fabbrocini G, Costa C, et al. Sonidegib with and without adjunctive treatment for locally advanced basal cell carcinomas. Oncology. 2022;27(6):e533.doi: 10.1093/oncolo/oyac063
  • Gambini D, Passoni E, Nazzaro G, et al. Basal cell carcinoma and hedgehog pathway inhibitors: focus on immune response. Front Med. 2022;9:893063. doi: 10.3389/fmed.2022.893063
  • Fujii K, Miyashita T. Gorlin syndrome (nevoid basal cell carcinoma syndrome): update and literature review. Pediatr Int. 2014; 56(5):667–674. doi: 10.1111/ped.12461
  • Camela E, Potestio L, Fabbrocini G, et al. New frontiers in personalized medicine in psoriasis. Expert Opin Biol Ther. 2022;22 (12):1431–1433. doi: 10.1080/14712598.2022.2113872

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