FDA Approves First Medicine for Advanced Basal Cell Carcinoma

Erivedge (vismodegib) recently approved by the FDA

The FDA recently announced the approval of Erivedge (vismodegib). This medication is available as a capsule that is taken orally once a day by adults with basal cell carcinoma (BCC) that:

  • Has metastasized
  • Has returned after surgery
  • Cannot be treated with surgery or radiation

“[This] approval provides a new treatment for people with advanced basal cell carcinoma who, until now, had no approved medicines to help shrink disfiguring or potentially life-threatening lesions,” said Hal Barron, MD, Chief Medical Officer and Head, Global Product Development.

The FDA approval was based on study results showing vismodegib minimized lesions in 43% (27/63) of patients with locally advanced BCC and 30% of patients (10/33) with metastatic BCC. The median duration of response was 7.6 months.

The most common side effects of vismodegib include muscle spasms, hair loss, change in how things taste or loss of taste, weight loss, tiredness, nausea, diarrhea, decreased appetite, constipation, vomiting, and joint aches.

Source: Roche.

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