In the international, multicentre, single-arm, open-label, 2-cohort study ERIVANCE BCC, the efficacy and safety of the oral hedgehog signaling pathway inhibitor.
The indication is granted market authorization based on objective response rate (ORR) demonstrated in a single-arm Phase II trial. Overall survival (OS) benefit in a single-arm trial cannot be confirmed.
In the pivotal trial, the majority of the clinical responses occurred within 16 weeks. Benefit of continued treatment should be regularly assessed, with the optimal duration of therapy varying for each individual patient.
Distribution Restrictions: ERIVEDGE is only available through a controlled distribution program called the ERIVEDGE Pregnancy Prevention Program (EPPP). For more information please contact the EPPP at 1-888-748-8926 or log onto rocheproplus.ca/en/products-resources/erivedge.html.
Geriatrics (≥65 years of age): Elderly patients should be treated with caution and monitored for adverse events.
Pediatrics (<18 years of age): The safety and efficacy of ERIVEDGE in pediatric patients has not been established. Irreversible premature fusion of the epiphyses and precocious puberty have been reported in pediatric patients exposed to ERIVEDGE. Premature fusion can progress after discontinuation of treatment. Due to safety concerns ERIVEDGE is contraindicated in children and adolescents aged below 18 years.
Female patients who are pregnant or at risk of becoming pregnant
Breastfeeding female patients
Female patients of childbearing potential (FCBP) and male patients who do not comply with the ERIVEDGE Pregnancy Prevention Program
Children and adolescents aged less than 18 years of age
Patients who are hypersensitive to vismodegib or to any ingredient in the formulation
Most serious warnings and precautions:
Embryo-fetal death or severe birth defects: Can cause severe malformations, including craniofacial anomalies, midline defects and limb defects when administered to a female who is pregnant. Must not be used during pregnancy.
Effects on post-natal development: Irreversible premature fusion of the epiphyses (EPF) and precocious puberty have been reported in pediatric patients exposed to ERIVEDGE. In some cases of EPF, fusion progressed after drug discontinuation.
Renal impairment: The safety and efficacy of ERIVEDGE in patients with severe renal impairment have not been studied. No dedicated clinical studies have been conducted to evaluate the effect of mild, moderate and severe renal impairment on the pharmacokinetics of vismodegib.
Hepatic impairment: ERIVEDGE is not recommended for use in patients with severe hepatic impairment since limited data are available in these patients. ERIVEDGE should be used with caution in patients with mild and moderate hepatic impairment.
Other relevant warnings and precautions:
Effects on post-natal development
Blood donation: Patients must not donate blood while on treatment and for 24 months after discontinuation
Patients with advanced BCC (aBCC) have an increased risk of developing cutaneous squamous cell carcinoma (cuSCC). Cases of cuSCC have been reported in aBCC patients treated with ERIVEDGE. All patients should be monitored routinely while taking ERIVEDGE
Cardiovascular-related events
Decreased appetite, decreased weight and dehydration
Electrolyte abnormalities
Hepatotoxicity
Patients with a history of pancreatitis or gallbladder disease
Gastrointestinal-related events
Anaemia and lymphopenia
Grade 1 hypersensitivity
Arthralgia, back pain, muscle spasms, fractures, and elevated creatine phospohokinase (CPK) measurements reported
Syncope, dysgeusia and ageusia
Psychiatric disorders
Renal disorders and cases of renal failure have been observed in patients treated with ERIVEDGE
Amenorrhea has been observed in clinical trials in 30% of FCBP (Female of Childbearing Potential). Potential to impair fertility in patients
Blood work monitoring
Please consult the Product Monograph for important information relating to warnings and precautions, adverse reactions, drug interactions, and dosing information that has not been discussed in this piece.
The Product Monograph is also available by calling us at 1-888-762-4388.
With objective response rates of 43% (laBCC) and 30% (mBCC), the ERIVANCE BCC study met its primary endpoint. At the initial data analysis, lesion size reduction was reported in 90% of patients in the laBCC cohort and remission or disease stabilization in 94% of the mBCC cohort. With a favorable tolerability profile, most adverse events were grade 1 or 2 in severity. 1
The results of the ERIVANCE BCC study are the basis of the European approval of Erivedge for the treatment of locally advanced basal cell carcinoma in patients for whom surgery or radiation therapy is not suitable and in patients with symptomatic metastatic basal cell carcinoma. This means that for the first time, targeted drug therapy is available for these patients, who have hitherto been inadequately treatable.
| mbCC (n=33) | laBCC (m=63) | |
| Age (median years) | 65% | 65% |
| Sex (male/female) | 65% |
65% |
| Race (Caucasian) | 65% |
65% |
Avastin is not currently funded in this country.
Roche provides a Cost Share Programme to assist with the cost of treatment. You can find out more about the programme by visiting the Avastin Cost Share Programme page.
The Hedgehog pathway is normally inactive in adult tissues but can be activated by mutations.
It is indicated for the treatment of:
WARNING: THROMBOTIC MICROANGIOPATHY AND THROMBOEMBOLISM (TE)
Cases of thrombotic microangiopathy (TMA) and thrombotic events were reported when on average a cumulative amount of > 100 U/kg/24 hours of activated prothrombin complex concentrate (aPCC) was administered for 24 hours or more to patients receiving Hemlibra prophylaxis. Monitor for the development of thrombotic microangiopathy and thrombotic events if aPCC is administered. Discontinue aPCC and suspend dosing of Hemlibra if symptoms occur.
