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

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.

Continue reading here:
FDA Approves Erivedge (Vismodegib) Capsule, the First Medicine for Adults with Advanced Basal Cell Carcinoma