The first half of 2020 will pass soon. Although foreign countries are still under the shadow of the COVID-19 pandemic, China’s situation is gradually stabilizing and improving through the concerted efforts of all to fight the pandemic. It is gratifying that there is no slacking in the approval of new anticancer drugs, whether in China or abroad. Many new drugs and therapies have been approved for marketing in May alone. Here is an overview of several representative important approvals in the oncology field for your reference.
The NMPA approved brentuximab vedotin for the treatment of lymphoma on May 14
May 14, 2020, Shanghai, China—Takeda China announced that its innovative targeted drug ADCETRIS (brentuximab vedotin for injection) was officially approved by the National Medical Products Administration of China (NMPA) to enter China, with the indication approved being the treatment of adult patients with CD30-positive relapsed or refractory systemic anaplastic large cell lymphoma (sALCL) or relapsed or refractory classical Hodgkin lymphoma (cHL).
Brentuximab vedotin comprises an anti-CD30 monoclonal antibody attached by a microtubule inhibiting cytotoxic agent, monomethyl auristatin E (MMAE), which can stably exist in the blood to precisely kill tumor cells that express CD30. The product is largely used in clinical trials and has sufficient real-world evidence and proven efficacy. Brentuximab vedotin has already been recommended as a standard therapeutic drug by the National Comprehensive Cancer Network (NCCN) Guidelines and also included in the scope of clinical choice by the Chinese Society of Clinical Oncology (CSCO) Guidelines.
The approval of brentuximab vedotin in China is based on the data from clinical studies SG035-0004, SG035-0003 and C25007. In the SG-035-0004 study, among 58 patients with relapsed or refractory sALCL, tumor reduction was seen in 97%, and their five-year survival rate increased to 60%. In the SG-035-0003 study, among patients with relapsed or refractory cHL, tumor reduction was seen in 94%, with the median overall survival (OS) increasing from a historical 27.6 months to 40.5 months. The C25007 study is a study of patients (n=60) with relapsed or refractory cHL who had received chemotherapy at least once and were not suitable for stem cell transplantation (SCT) or multidrug chemotherapy when they began to receive treatment with brentuximab vedotin. In this study, the objective remission rate (ORR) for the subjects was 50% (95% CI, 37: 63%)
For decades, treatment options for patients in China with sALCL or cHL have been very limited. Brentuximab vedotin, an anti-CD30 innovative antibody-drug conjugate (ADC), can fill the gap in the field of CD30-positive lymphoma therapeutics in China.
The marketing application for another Chinese-produced anti-PD-1 monoclonal antibody was accepted by the NMPA on May 26!
Sino Biopharmaceutical announced on May 26 that the marketing application for the new drug Annike (generic name: penpulimab; R&D code: AK105), an anti-PD-1 monoclonal antibody jointly developed and commercialized by the company and Akeso, was accepted by the NMPA to treat patients with relapsed or refractory cHL. Up to now, AK105 will be the t...
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