Generic Name and Formulations:
Vismodegib 150mg; caps.
Company:
Genentech, Inc.
Indications for ERIVEDGE:
Treatment of adults with metastatic basal cell carcinoma, or locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation.
Adult Dose for ERIVEDGE:
Swallow whole. 150mg once daily, until disease progression or unacceptable toxicity.
Children's Dose for ERIVEDGE:
Not established.
Pharmacological Class:
Hedgehog pathway inhibitor.
Warnings/Precautions:
Risk of embryo-fetal death and severe birth defects in pregnant women. Verify pregnancy status prior to initiation of therapy. Counsel patients (males and females) on the need for contraception during and after treatment. Advise patients not to donate blood or blood products while on therapy and for at least 7 months after last dose. Pregnancy (Cat.D). Nursing mothers: not recommended.
Interactions:
May be potentiated by P-gp inhibitors (eg, clarithromycin, erythromycin, azithromycin). May be antagonized by drugs that affect gastric pH (eg, proton pump inhibitors, H2-receptor antagonists, antacids).
Adverse Reactions:
Muscle spasms, alopecia, dysgeusia, weight loss, fatigue, GI upset, decreased appetite, constipation, arthralgias, ageusia.
Note:
Report immediately exposure to Erivedge during pregnancy by contacting the Genentech Adverse Event Line at (888) 835-2555.
How Supplied:
Caps—28
Erivedge Approved for Advanced Basal Cell Carcinoma
ERIVEDGE (vismodegib) 150mg capsules by Genentech Genentech announced that the FDA has approved Erivedge (vismodegib capsules) for the treatment of adults with advanced basal cell carcinoma (BCC), that has spread to other parts of the body or that has come back after surgery or that their healthcare provider decides cannot be treated with surgery or radiation.
This approval was based on results from the ERIVANCE BCC (SHH4476g) study, an international, single-arm, multicenter, two-cohort, open-label, Phase 2 study that enrolled 104 patients with advanced BCC, including locally advanced BCC and metastatic BCC. Patients received Erivedge 150mg orally, once daily until disease progression or unacceptable toxicity. The study showed Erivedge shrank lesions (objective response rate, or ORR) in 43% of patients with locally advanced BCC and 30% of patients with metastatic BCC, as assessed by independent review, the primary endpoint of the study. The median duration of response was 7.6 months.
Erivedge is expected to be available in February 2012 and will be distributed through specialty pharmacies.
Vismodegib Has Antitumor Activity in Basal Cell Carcinoma
Vismodegib Has Antitumor Activity in Basal Cell Carcinoma (HealthDay News) – A small-molecule inhibitor of the hedgehog pathway, vismodegib, is associated with tumor response in patients with metastatic or locally advanced basal cell carcinoma (BCC); and vismodegib is efficacious for preventing and treating BCCs in patients with basal cell nevus syndrome, according to two studies published in the June 7 issue of the New England Journal of Medicine.
Aleksandar Sekulic, MD, PhD, from the Mayo Clinic in Scottsdale, AZ, and colleagues enrolled 33 patients with metastatic BCC and 63 with locally advanced BCC in a multicenter, international, two-cohort, nonrandomized study. Participants received 150mg oral vismodegib daily. The researchers found that the objective response rate was 30% in the patients with metastatic BCC and 43% in those with locally advanced BCC, with complete responses in 21% of patients in the cohort with locally advanced BCC. In both cohorts, the median duration of response was 7.6 months.
Jean Y. Tang, MD, PhD, from the Children's Hospital of Oakland Research Institute in California, and colleagues conducted a randomized, double-blind, placebo-controlled trial of vismodegib involving 41 patients with basal cell nevus syndrome. After a mean follow-up of eight months, the researchers found that the per-patient rate of new surgically eligible BCCs was significantly lower with vismodegib than placebo. The size of existing clinically significant BCCs was also significantly smaller with vismodegib. Due to adverse events, 54% of patients receiving the drug discontinued vismodegib treatment.
"Our findings confirm the essential role of the hedgehog pathway in basal cell carcinomas and indicate that vismodegib is efficacious in preventing and treating basal cell carcinomas in patients with the basal cell nevus syndrome," Tang and colleagues conclude.
Authors from both studies disclosed financial ties to pharmaceutical companies, including Genentech, which funded the studies and developed vismodegib.
