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FDA Approves Genentech (RHHBY)'s Erivedge (Vismodegib) Capsule, the First Medicine for Adults with Advanced Basal Cell Carcinoma


1/30/2012 9:16:40 AM

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that ErivedgeTM (vismodegib) capsule was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with a type of skin cancer, called 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. Erivedge is the first FDA-approved medicine for people with advanced forms of the most common skin cancer. It is a capsule that is taken orally once-a-day.

Basal cell carcinoma is generally considered curable if the cancer is restricted to a small area of the skin. However, in rare cases, lesions can become disfiguring and invade surrounding tissue (locally advanced) or spread to other parts of the body (metastasize). In these cases of advanced BCC, the disease cannot be effectively treated with surgery or radiation. Advanced BCC often results in severe deformity or loss of function of affected organs.

“Today’s 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, M.D., chief medical officer and head, Global Product Development. “We are pleased that in the last six months we have been able to provide two new medicines for different types of advanced skin cancer to people who previously had few or no treatment options.”

Erivedge will be available in the United States within one-to-two weeks of approval and will be distributed through specialty pharmacies. For more information about Erivedge distribution in the United States, doctors can contact Erivedge Access Solutions (http://www.ErivedgeAccessSolutions.com or 1-888-249-4918). Erivedge Access Solutions also provides doctors and patients coverage and reimbursement support, patient assistance and information resources.

Roche has also submitted a marketing authorization application (MAA) for Erivedge in the European Union (EU). In order to provide people with advanced BCC who live outside of the United States access to Erivedge while Roche pursues marketing authorization worldwide, the company is conducting a Phase II safety study in the EU and other countries that is enrolling patients with advanced BCC. For more information, please access http://www.rochetrials.com.

Erivedge Efficacy in Advanced Basal Cell Carcinoma

The FDA approval of Erivedge is based on results from ERIVANCE BCC (SHH4476g), a pivotal international, single-arm, multicenter, two-cohort, open-label, Phase II study that enrolled 104 patients with advanced BCC, including locally advanced BCC (71) and metastatic BCC (33).

The study showed Erivedge shrank lesions (objective response rate, or ORR) in 43 percent (27/63) of patients with locally advanced BCC and 30 percent of patients (10/33) with metastatic BCC, as assessed by independent review, the primary endpoint of the study. The median duration of response was 7.6 months.

Patients with locally advanced BCC had lesions that recurred after surgery, were not candidates for surgery (inoperable, or for whom surgery would result in substantial deformity), recurred after radiotherapy or were not candidates for radiotherapy (radiotherapy was contraindicated or inappropriate). Study participants received 150 mg of Erivedge orally, once daily until disease progression or unacceptable toxicity.

Important Safety Information

Erivedge can cause a baby to die before it is born (be stillborn) or cause a baby to have severe birth defects based on how the medicine interacts with the body.

For females who can become pregnant:

• Female patients should talk with their healthcare provider about the risks of Erivedge to their unborn child. • Their healthcare provider should do a pregnancy test within seven days before they start taking Erivedge to find out if they are pregnant.

• In order to avoid pregnancy, patients should start using highly effective birth control before they start Erivedge and continue to use highly effective birth control during treatment, and for seven months after their last dose of Erivedge. Patients must talk with their healthcare provider about what birth control method is right for them during this time.

• Patients must talk to their healthcare provider right away if they have unprotected sex or if they think that their birth control has failed.

• Patients must tell their healthcare provider right away if they become pregnant or think that they may be pregnant. Pregnant women are encouraged to participate in a program that collects information about exposure to Erivedge during pregnancy and the effects on the mother and her unborn child. This program is called the Erivedge pregnancy pharmacovigilance program. To participate in this program, patients can call the Genentech Adverse Event Line at 1-888-835-2555.

For males:

• Male patients should always use a condom with a spermicide, even if they have had a vasectomy, during sex with female partners while they are taking Erivedge and for two months after their last dose to protect their female partner from being exposed to Erivedge.

• Patients must tell their healthcare provider right away if their partner becomes pregnant or thinks she is pregnant while they are taking Erivedge.

Patients must not donate blood or blood products while they are taking Erivedge and for seven months after their last dose.

It is not known if Erivedge passes into breast milk. Patients and their healthcare provider should decide if the patient will take Erivedge or breastfeed. Patients should not do both.

The most common side effects of Erivedge are 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.

Other side effects may include missed monthly periods in females who can become pregnant, low levels of sodium in the blood, low potassium levels, and a higher than normal blood level of urea or other nitrogen containing compounds in the blood.

Patients should tell their healthcare provider if they have any side effect that bothers them or that does not go away.

These are not all the possible side effects of Erivedge. For more information, patients should ask their healthcare provider or pharmacist. Please see the full prescribing information for Erivedge, including the Boxed WARNING and Medication Guide at http://www.Erivedge.com.

About Basal Cell Carcinoma and the Hedgehog Pathway

Basal cell carcinoma is the most common type of skin cancer in Europe, Australia and the United States. In advanced BCC, if the disease is left untreated or recurs in the same location after surgery or radiotherapy, it may advance further into surrounding areas such as sensory organs (ears, nose and eyes), bone or other tissues. Depending on the location of the lesion, some cases of advanced BCC can be disfiguring, and treatment with surgery or radiation can lead to the loss of sensory organs and their functions such as eyesight or hearing.

The Hedgehog signaling pathway plays an important role in regulating proper growth and development in the early stages of life and becomes less active in adults. Abnormal Hedgehog signaling is implicated in more than 90 percent of BCC cases.

About Erivedge (pronounced EH-rih-vej); vismodegib (pronounced vis-mo-DEJ-ib)

Erivedge is an oral medicine designed to selectively inhibit abnormal signaling in the Hedgehog pathway, which is an underlying molecular driver of BCC. Roche and Genentech are also evaluating Erivedge in a Phase II trial in people with operable forms of BCC.

Roche is developing Erivedge under a collaboration agreement with Curis, Inc. Erivedge was discovered by Genentech and jointly validated by Genentech and Curis through a series of preclinical studies. Through this collaboration, Genentech (United States), Roche (ex-United States excluding Japan and Korea) and Chugai Pharmaceuticals (Japan and Korea) are responsible for the clinical development and commercialization of Erivedge. Curis is eligible to receive cash payments upon the successful achievement of specified clinical development and regulatory approval milestones, as well as royalties upon commercialization of Erivedge.

About Genentech Access Solutions

Genentech is committed to people having access to our medicines. Genentech Access Solutions is a team of more than 350 Genentech employees helping those who need Genentech medicines. Our knowledgeable and experienced Specialists can help patients and medical practices navigate the access and reimbursement process and provide 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 more information, please visit http://www.GenentechAccessSolutions.com.

About Genentech

Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

Contacts

Genentech

Media Contact:

Emmy Wang, 650-467-6800

or

Advocacy Contact:

Sonali Padhi, 650-467-0842

or

Investor Contacts:

Thomas Kudsk Larsen, 650-467-2016

Karl Mahler, 011 41 61 687 8503


Read at BioSpace.com

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