Erivedge is the first and only FDA-approved, once-daily, orally administered treatment for adult patients with advanced BCC.
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Learn how to get Erivedge
| Objective response rates (ORR) from the ERIVANCE trial by Independent Review Facility1* |
| |
Locally advanced BCC (n=63) |
Metastatic BCC (n=33) |
| ORR |
| (95% CI) |
| Complete response |
| Partial response |
| Median response |
| duration (months) |
| (95% CI) |
|
| 42.9% |
| (30.5, 56.0) |
| 20.6% |
| 22.2% |
| . |
| 7.6 |
| (5.7, 9.7) |
|
| 30.3% |
| (15.6, 48.2) |
| 0.0% |
| 30.3% |
| . |
| 7.6 |
| (5.6, NE) |
|
| * |
Patients who received at least one dose of Erivedge with independent pathologist-confirmed diagnosis of BCC. Locally advanced BCC patients were considered responders if they did not experience progression and had >30% reduction in lesion size (sum of the longest diameter) from baseline in target lesions by radiography or in externally visible dimension of target lesions (scar tissue was measured); or had complete resolution of ulceration in all target lesions. Complete response was objective response with no residual BCC on sampling biopsy. Partial response was objective response with presence of residual BCC on sampling biopsy. In the mBCC cohort, response was assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0.
CI=confidence interval. NE=not estimable. |
Consider these factors when SELECTing patients
with locally advanced BCC for Erivedge2 |
 |
 |
|
 |
SIZE (>10 mm in diameter)
|
 |
EXTENT (Locally invasive, ie, tumor extending into underlying tissue cartilage, bone, or nerve) |
 |
LOCATION (Surgery or radiation would result in significant disfiguration or loss of function) |
|
EXPECTED MORBIDITY OR DEFORMITY
(If surgery or radiation were to be performed) |
 |
CURATIVE RESECTION UNLIKELY / CONTRAINDICATION TO SURGERY |
 |
TWO OR MORE RECURRENCES (In the same location after 2 or more surgical procedures) |
Erivedge is also appropriate for patients with metastatic BCC.
Vismodegib is an inhibitor of the Hedgehog pathway. Vismodegib binds to and inhibits Smoothened, a transmembrane protein involved in Hedgehog signal transduction. Erivedge capsule can cause fetal harm when administered to a pregnant woman based on its mechanism of action.
Erivedge will be available in the United States within 1 week of approval and will be distributed through specialty pharmacies (mail-order pharmacies).
For more information about Erivedge distribution, healthcare professionals can contact Erivedge Access Solutions® (ErivedgeAccessSolutions.com or (888) 249-4918) or log on to www.Erivedge.com. Erivedge Access Solutions also provides healthcare professionals and patients coverage and reimbursement support, patient assistance and information resources.
For more information on how Erivedge Access Solutions can help,
there will be a conference call and webcast to discuss Erivedge Access Solutions reimbursement and patient assistance programs.
Conference Call Details
The call will be held Friday, February 17, 2012 at 3 different times. Log into: genentech.webex.com
- 9 AM Pacific Time (PT) Passcode: 596 025 145
- 11 AM Pacific Time (PT) Passcode: 277 905 660
- 12 PM Pacific Time (PT) Passcode: 593 596 436
The live event will be available by calling (888) 442-7245. The access code is 436284.
About Genentech Access Solutions
Genentech is committed to people having access to our medicines. Genentech Access Solutions is a team of 450 Genentech employees who help those who need Genentech medicines. This team works with patients and healthcare professionals to resolve reimbursement and insurance issues and provides assistance to eligible patients in the United States who do not have insurance coverage or who cannot afford their out-of-pocket co-pay costs. For additional information, please visit ErivedgeAccessSolutions.com.
References:
1. Erivedge™ (vismodegib) capsule Prescribing Information.
Genentech, Inc. January 2012.
2. Data on file. Genentech, Inc.
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Indication
Erivedge™ (vismodegib) capsule is indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation.
WARNING: EMBRYO-FETAL DEATH AND SEVERE BIRTH DEFECTS
Erivedge (vismodegib) capsule can result in embryo-fetal death or severe birth defects. Erivedge is embryotoxic and teratogenic in animals. Teratogenic effects included severe midline defects, missing digits, and other irreversible malformations.
Verify pregnancy status prior to the initiation of Erivedge. Advise male and female patients of these risks. Advise female patients of the need for contraception and advise male patients of the potential risk of Erivedge exposure through semen. |
|
Boxed Warning and Additional Important Safety Information
Embryo-Fetal Death and Severe Birth Defects
| • |
Erivedge capsule can cause fetal harm when administered to a pregnant woman based on its mechanism of action. Erivedge is embryotoxic and teratogenic in animals. Teratogenic effects included severe midline defects, missing digits, and other irreversible malformations |
| • |
Verify pregnancy status prior to the initiation of Erivedge. Advise male and female patients of these risks. Advise female patients of the need for contraception during and after treatment and advise male patients of the potential risk of Erivedge exposure through semen |
| • |
Advise patients to contact their healthcare provider immediately if they suspect they (or, for males, their female partner) may be pregnant |
| • |
Immediately report exposure to Erivedge during pregnancy and encourage women who may have been exposed to Erivedge during pregnancy, either directly or through seminal fluid, to participate in the Erivedge pregnancy pharmacovigilance program by contacting the Genentech Adverse Event Line at (888) 835-2555 |
Blood Donation
| • |
Advise patients not to donate blood or blood products while receiving Erivedge and for at least 7 months after the last dose of Erivedge |
Nursing Mothers
| • |
Inform female patients of the potential for serious adverse reactions in nursing infants from Erivedge, taking into account the importance of the drug to the mother |
Adverse Reactions
| • |
The most common adverse reactions (>10%) were muscle spasms, alopecia, dysgeusia, weight loss, fatigue, nausea, diarrhea, decreased appetite, constipation, arthralgias, vomiting, and ageusia |
| • |
In clinical trials, a total of 3 of 10 premenopausal women developed amenorrhea while receiving Erivedge |
| • |
Treatment-emergent grade 3 laboratory abnormalities observed in clinical trials were hyponatremia in 6 patients
(4%), hypokalemia in 2 patients (1%), and azotemia in 3 patients (2%) |
Please see the full Prescribing Information for a complete discussion of the risks associated with Erivedge, including the BOXED WARNING and the Medication Guide.
For more information, please visit www.Erivedge.com. |
