EMA's CHMP Issues Positive Opinion for Avelumab for the Treatment of Metastatic Merkel Cell Carcinoma - Seite 2

in the EU, a medicine must be intended for the treatment, prevention
or diagnosis of a disease that is life-threatening or chronically
debilitating, and has a prevalence in the EU of not more than 5 in
10,000 people.

The US Food and Drug Administration (FDA) granted accelerated
approval for avelumab in March 2017 for the treatment of mMCC in
adults and pediatric patients 12 years and older; and in May 2017 for
the treatment of patients with locally advanced or metastatic
urothelial carcinoma who have disease progression during or following
platinum-containing chemotherapy therapy, or who have disease
progression within 12 months of neoadjuvant or adjuvant treatment
with platinum-containing chemotherapy.[1] These indications were
granted under accelerated approval based on tumor response rate and
duration of response data/criteria. Continued approval for these
indications may be contingent upon verification and description of
clinical benefit in confirmatory trials.

The clinical development program for avelumab, known as JAVELIN,
involves at least 30 clinical programs and more than 6,000 patients
evaluated across more than 15 different tumor types. In addition to
mMCC, these cancers include breast, gastric/gastro-esophageal
junction, head and neck, Hodgkin's lymphoma, melanoma, mesothelioma,
non-small cell lung, ovarian, renal cell carcinoma and urothelial
carcinoma.

* Avelumab is not approved for any indication in any market
outside the US. BAVENCIO® is the proprietary name submitted to EMA
for the investigational medicine avelumab.

About Metastatic Merkel Cell Carcinoma

Metastatic MCC is a rare and aggressive disease in which cancer
cells form in the top layer of the skin, close to nerve
endings.[2],[3] MCC, which is also known as neuroendocrine carcinoma
of the skin or trabecular cancer, often starts in those areas of skin
that are most often exposed to the sun, including the head and neck,
and arms.[2],[4] Risk factors for MCC include sun exposure and
infection with Merkel cell polyomavirus. Caucasian males older than
50 are at increased risk.[2],[4] MCC is a highly immunogenic cancer,
meaning that those with a weak immune system (i.e., solid organ
transplant recipients, people with HIV/AIDS and people with other
cancers, such as chronic lymphocytic leukemia) are also at a higher
risk.[2],[4] MCC is often misdiagnosed for other skin cancers and
grows at an exponential rate on chronically sun-damaged skin.[4]-[6]
Current treatment options for MCC in Europe include surgery,
radiation and chemotherapy.[3] Treatment for metastatic or Stage IV
MCC is generally palliative.[3]

About JAVELIN Merkel 200