Merck KGaA and Pfizer Inc. recently obtained approval of Bavencio (avelumab) as Japan’s first treatment for Merkel cell carcinoma (MCC), citing endorsement from the Japanese Ministry of Health, Labor and Welfare (MHLW).
Pfizer’s Dr. Andreas Penk, who serves as regional president for the firm’s international developed oncology markets, noted that the authorization represents the fifth endorsement for Bavencio in 2017 as well as its first in Asia, according to an announcement.
"[This] 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," Penk said in the announcement.
MCC is categorized as a rare disease in Japan, with under 100 diagnoses estimated. Bavencio initially received orphan drug designation from Japan’s MHLW in December.
Dr. Naoya Yamazaki of Japan’s National Cancer Center Hospital, who serves as chief of dermatologic oncology, said that previously, the country had no legalized treatments for MCC, calling the authorization “a huge step forward” in combating the fast-progressing disease.
"[A]pproval of the first-ever treatment indicated for Merkel cell carcinoma in Japan [makes] this a significant milestone for patients living with this devastating type of skin cancer," Dr. Luciano Rossetti, executive vice president and global head of research and development at Merck KGaA in Darmstadt, Germany, said in the announcement. "This decision by the MHLW also signifies the first approval of an anti-PD-L1 in Japan."