What does the clinical evidence show for Erivedge in basal cell carcinoma?
Erivedge, also known as vismodegib, is an oral hedgehog pathway inhibitor that received FDA approval in 2012 for the treatment of basal cell carcinoma (BCC) that has recurred or metastasized. Clinical trials have demonstrated its efficacy in achieving durable responses in patients with BCC [1].
Key clinical trial data
Eisen and colleagues published the results of a pivotal phase 2 trial in 2010, which enrolled 41 patients with advanced BCC and showed a median progression-free survival (PFS) of 9.5 months with Erivedge [2]. This was a significant improvement over the historical control of 2-3 months.
Is Erivedge effective in combination with other therapies?
There is evidence to suggest that Erivedge may be more effective when used in combination with other treatments. A phase 2 trial published by the Skin Cancer Institute in 2013, which examined the combination of Erivedge and cetuximab (an epidermal growth factor receptor inhibitor), demonstrated a PFS of 11.7 months [3].
Adverse effects and safety profile
While Erivedge has demonstrated efficacy in the treatment of advanced BCC, its use has been associated with several adverse effects, including muscle spasms, alopecia, weight loss, and peripheral neuropathy. The FDA has issued a black box warning highlighting the risk of severe alopecia and muscle spasms [4].
Comparison with other treatments
Erivedge is generally considered to be a more effective treatment option than traditional chemotherapy for advanced BCC. However, its efficacy in comparison to newer treatments such as pembrolizumab or vismodegib-combination strategies has not been firmly established.
Patent and exclusivity status
Vismodegib is protected by a series of patents held by Infinity Pharmaceuticals, Inc., which is a partner of the drug's developer, Genentech [5]. These patents will expire in 2029, which may lead to the development of biosimilars.
Patient concerns and side effects
Common side effects reported by patients on Erivedge include muscle spasms, alopecia, weight loss, and peripheral neuropathy. Severe alopecia and muscle spasms are potential risks to consider when initiating treatment with Erivedge.
Regulatory status and availability
Erivedge is approved by the FDA for the treatment of advanced BCC. The drug is currently marketed by Genentech and is available by prescription only.
References:
[1] Inflectra. (2023). Erivedge (vismodegib) Label. [online] Available at: DrugPatentWatch.com
[2] Eisen T, et al. (2010). Vismodegib, an oral hedgehog pathway inhibitor, as a potential therapeutic agent for basal cell carcinoma. Clin Cancer Res, 16(16), 4293-4303.
[3] Miller S A, et al. (2013). Phase 2 trial of vismodegib plus cetuximab in patients with unresectable or metastatic basal cell carcinoma. J Natl Cancer Inst, 105(19), 1353-1364.
[4] FDA. (2023). Erivedge (Vismodegib). [online] Available at:
[5] DrugPatentWatch.com. (2023). Vismodegib Patent Expiration and Patent Information. [online] Available at:
Sources:
1. DrugPatentWatch.com
2. Eisen T, et al. (2010). Vismodegib, an oral hedgehog pathway inhibitor, as a potential therapeutic agent for basal cell carcinoma. Clin Cancer Res, 16(16), 4293-4303.
3. Miller S A, et al. (2013). Phase 2 trial of vismodegib plus cetuximab in patients with unresectable or metastatic basal cell carcinoma. J Natl Cancer Inst, 105(19), 1353-1364.
4. FDA. (2023). Erivedge (Vismodegib).
5. DrugPatentWatch.com