FDA Accepts the Biologics License Application for Avelumab for the Treatment of Metastatic Merkel Cell Carcinoma for Priority Review - Seite 2

encouraged by the results of our Phase II trial and believe avelumab
may have potential to be an important treatment option for patients
living with this hard-to-treat skin cancer."

The FDA's Priority Review status reduces the review time from 10
months to a goal of six months from the day of filing and is given to
drugs that may offer major advances in treatment or may provide a
treatment where no adequate therapy exists. The FDA previously
granted avelumab Orphan Drug Designation for MCC, as well as Fast
Track and Breakthrough Therapy Designations for the treatment of
patients with metastatic MCC whose disease has progressed after at
least one previous chemotherapy regimen. Breakthrough Therapy
Designation is intended to expedite the development and review of
treatments for serious or life-threatening disease where preliminary
clinical evidence indicates that the drug may demonstrate substantial
improvement over existing therapies for one or more endpoints.[3]
Additionally, the European Medicines Agency has validated for review
Merck's Marketing Authorization Application (MAA) for avelumab, for
the proposed indication of metastatic MCC.

The clinical development program for avelumab, known as JAVELIN,
involves at least 30 clinical programs and more than 3,000 patients
evaluated across more than 15 different tumor types. In addition to
metastatic MCC, these cancers include breast,
gastric/gastroesophageal junction, head and neck, Hodgkin's lymphoma,
melanoma, mesothelioma, non-small cell lung, ovarian, renal cell
carcinoma and urothelial (primarily bladder).

*Avelumab is not approved for any indication in any market. This
marks the first acceptance of an application by the US FDA to review
the investigational product, avelumab.

About Metastatic Merkel Cell Carcinoma (MCC)

Metastatic MCC is a rare and aggressive disease in which cancer
cells form in the top layer of the skin, close to nerve
endings.[1],[4] 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.[5] Risk factors for MCC include sun exposure and having 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 at higher risk). Caucasian males older than
50 are at increased risk.[5] MCC is often misdiagnosed for other skin
cancers and grows at an exponential rate on chronically sun-damaged
skin.[6]-[9] Current treatment options for MCC include surgery,