China OKs DLBCL combo

InnoCare Pharma, a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced that the China National Medical Products Administration (NMPA) has granted approval for Minjuvi (tafasitamab), a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT). This is the first CD19 antibody approved for the treatment of relapsed or refractory DLBCL in China.

“The data from the Chinese clinical study of Minjuvi - similar to the data from the global L-MIND study – reaffirms the significant clinical benefits for DLBCL patients treated with the Minjuvi combination, particularly the notably prolonged duration of response (DOR),” said Professor Jie Jin from the First Affiliated Hospital, Zhejiang University School of Medicine. “The approval of Minjuvi is a crucial milestone for eligible patients with DLBCL in China, and we hope this innovative therapy will benefit patients.”

“The durable responses and consistent safety profile observed in both the Chinese and global studies are encouraging and support the Minjuvi regimen as an effective option for patients with DLBCL,” said Professor Weili Zhao from Shanghai Ruijin Hospital. “We are pleased that the first prescription of the Minjuvi regimen was filled in China at Ruijin Hainan Hospital for an eligible DLBCL patient under the early access program in Bo’ao. Looking ahead, we hope that more eligible patients with DLBCL will benefit from this novel therapy.”

Dr. Jasmine Cui, co-founder, chairwoman and CEO of InnoCare, said, “Today's approval marks another important milestone for InnoCare as we will celebrate our 10th anniversary this year. I would like to extend my sincere gratitude to all the physicians, patients, partners and employees who have contributed to this achievement. DLBCL is the most common form of non-Hodgkin lymphoma globally, and there are significant unmet needs among patients with DLBCL in China. We believe the Minjuvi regimen will provide a novel therapeutic option to patients with DLBCL in China.”

Tafasitamab, a humanized Fc-modified cytolytic CD19-targeting immunotherapy, in combination with lenalidomide, has already been approved for the treatment of eligible DLBCL patients in the region of Hong Kong, Macau and Taiwan. Furthermore, under the early access program in the Bo’ao Lecheng International Medical Tourism Pilot Zone and the Guangdong-Hong Kong-Macao Greater Bay Area, prescriptions of tafasitamab in combination with lenalidomide have been issued at Ruijin Hainan Hospital and Guangdong Clifford Hospital for eligible DLBCL patients.