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

Darmstadt, Germany and New York (ots/PRNewswire) -

Not intended for UK-based media

- If approved by the FDA, avelumab, an investigational immunotherapy,
could be the first treatment indicated for patients with metastatic
Merkel cell carcinoma (MCC)
- Avelumab has previously received FDA Breakthrough Therapy and Fast
Track Designations for metastatic MCC, as well as FDA Orphan Drug
Designation for MCC

Merck and Pfizer Inc. (NYSE: PFE) today announced that the US Food
and Drug Administration (FDA) has accepted for Priority Review the
Biologics License Application (BLA) for avelumab, which was submitted
by EMD Serono, the biopharmaceutical business of Merck in the US and
Canada. This review relates to avelumab's proposed use in patients
with metastatic Merkel cell carcinoma (MCC), based on tumor response
results from the JAVELIN Merkel 200 trial. Avelumab is an
investigational fully human anti-PD-L1 IgG1 monoclonal antibody and
could be the first treatment indicated for metastatic MCC in the US,
if approved.* MCC is a rare and aggressive skin cancer, which impacts
approximately 2,500 Americans a year.[1],[2]

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"We are pleased the FDA has granted a Priority Review designation
for avelumab," said Luciano Rossetti, M.D., Executive Vice President,
Global Head of Research & Development at the biopharma business of
Merck. "There are currently no approved treatment options for
metastatic MCC, and we are committed to working with the FDA to
potentially bring the first approved cancer immunotherapy to patients
with this aggressive disease."

The avelumab metastatic MCC BLA submission is supported by data
from JAVELIN Merkel 200, a multicenter, single-arm, open-label, Phase
II study of 88 patients with metastatic MCC, whose disease had
progressed after at least one chemotherapy treatment.[1] The JAVELIN
Merkel 200 study represents the largest data set of any
anti-PD-L1/PD-1 antibody reported in this patient population. These
data were presented in June 2016 at the Annual Meeting of the
American Society of Clinical Oncology (ASCO) and published in the
Lancet Oncology in October 2016.[1]

"Metastatic Merkel cell carcinoma is an aggressive disease, and
patients face a very poor prognosis, with less than 20 percent
surviving beyond five years," said Chris Boshoff, M.D., Ph.D., Senior
Vice President and Head of Immuno-oncology, Early Development and
Translational Oncology, Pfizer Global Product Development. "We are