Merck KGaA, Darmstadt, Germany, and Pfizer Inc. today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved BAVENCIO® (avelumab, genetically recombinant Injection 200mg/mL for intravenous use) as the first and only treatment indicated for curatively unresectable Merkel cell carcinoma (MCC), a rare and aggressive cancer, in Japan.
"Today marks the approval of the first-ever treatment indicated for Merkel cell carcinoma in Japan, making this a significant milestone for patients living with this devastating type of skin cancer," said Luciano Rossetti, M.D., Executive Vice President, Global Head of Research & Development at the biopharma business of Merck KGaA, Darmstadt, Germany, which operates as EMD Serono in the US and Canada. "This decision by the MHLW also signifies the first approval of an anti-PD-L1 in Japan."
"This is the fifth approval for BAVENCIO in 2017 and the first in an Asian market," said Andreas Penk, M.D., Regional President Oncology International Developed Markets, Pfizer Oncology. "Today's announcement demonstrates our continued determination to provide access to our immunotherapy for people around the world living with hard-to-treat cancers such as Merkel cell carcinoma."
MCC is a designated rare disease in Japan and is estimated to affect fewer than 100 patients. BAVENCIO previously received Orphan Drug Designation from the MHLW in December 2016.
"Until now, there were no licensed treatments for MCC in Japan," said Dr Naoya Yamazaki, Chief of the Department of Dermatologic Oncology, National Cancer Center Hospital, Japan. "As a cancer that progresses quickly and has, for so many, a poor prognosis, today's approval is a huge step forward for people impacted by this destructive disease."
This approval is based on data from JAVELIN Merkel 200, an international, multicenter, single-arm, open-label, Phase II study in patients with metastatic MCC.
The JAVELIN Merkel 200 study is the largest registrational clinical trial for an immunotherapy in metastatic MCC. The results of this study were previously presented at the June 2016 American Society of Clinical Oncology annual congress and published in the October 2016 edition of Lancet Oncology.
The MHLW's decision follows BAVENCIO's recent approval by the European Commission on September 18, 2017, as a monotherapy for the treatment of adult patients with metastatic MCC (mMCC). BAVENCIO was also granted marketing authorization by Swissmedic on September 05, 2017, for the treatment of patients with mMCC, whose disease has progressed after at least one chemotherapy treatment. Earlier this year, the US Food and Drug Administration (FDA) granted accelerated approval for BAVENCIO for the treatment of mMCC and patients with locally advanced or metastatic urothelial carcinoma (UC) who have disease progression during or following platinum-containing chemotherapy.
The clinical development program for BAVENCIO, known as JAVELIN, involves at least 30 clinical programs and more than 6,300 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.