Numerous anticancer drugs were marketed in China in 2019. Let’s today review the 7 blockbuster innovative oncology drugs approved by the NMPA (National Medical Products Administration of China) in 2019, which have greatly improved the treatment dilemma of oncology patients in China.
The first biosimilar in China: Rituximab Injection
The NMPA approved the marketing registration application of the Rituximab Injection (trade name: Hanlikang) developed by Shanghai Henlius Biotech, Inc. on Feb. 22, 2019. As the first biosimilar approved in China, the drug is mainly used to treat non-Hodgkin lymphoma. The approval of Hanlikang was based on a multicenter (33 centers), randomized, double-blind phase III clinical study that enrolled 407 untreated CD20-positive DLBCL subjects who were separately treated with the regimen of Hanlikang in combination with CHOP (H-CHOP) and regimen of Rituxan in combination with CHOP (R-CHOP), with the primary endpoint being the optimal overall response rate (ORR) within 6 cycles.
The results showed that the therapeutic equivalence between the Hanlikang group and Rituxan group was established (92.5% vs 92.1%), and the two groups had no statistical difference (P>0.05) in terms of the safety data. The results of this phase III clinical study mean that Hanlikang’s efficacy and safety are similar to those of Rituxan. Hanlikang has also been approved by the Chinese Pharmacopoeia Commission to use the generic name of Rituximab Injection.
Second-generation EGFR-TKI: dacomitinib
There was big news on May 15, 2019 that the new oncology drug dacomitinib (trade name: Vizimpro) was approved for marketing in China! Developed by the well-known pharmaceutical enterprise Pfizer, dacomitinib belongs to second-generation EGFR-TKIs, with the indication approved being "monotherapy for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR-activating mutations (exon 19 deletion or exon 21 L858R substitution mutations)". The approval of the drug was based on an international, multicenter, randomized, open-label, phase III clinical study (ARCHER1050) that assessed the efficacy and safety of dacomitinib (second-generation EGFR-TKI) or gefitinib (first-generation EGFR-TKI).
The competition of the EGFR-targeted drugs for lung cancer is fierce, with many marketed, including the first-generation (gefitinib, etc.), second-generation (afatinib) and third-generation (osimertinib) drugs.
Even in this case, though, the marketing of dacomitinib in China still attracted great attention because 1: its median progression-free survival in the clinical trial of the Chinese patients with EGFR mutations reached 18.4 months far more than that of the first-generation drug; 2: it is currently the only targeted drug proved to have significantly prolonged the overall survival of patients with EGFR mutations compared to the standard therapy. The drug has now been approved in the U.S., the EU, Japan, and Canada, etc. as a first-line treatment.
China’s first and only drug for the giant cell tumor of bone: denosumab
Denosumab (trade name: Xgeva) was approved by the NMPA on May 21, 2019 to treat adults and skeletally mature adolescents (defined as having at least one mature long bone and weighing >45 kg) with giant cell tumor of bone (GCTB) that is unresectable or where surgical resection is likely to result in severe morbidity. It is China’s first and only drug for the GCTB.
The analysis of the Study 20040215 announced at the 2017 European Society for Medical Oncology (ESMO) annual meeting showed that the overall response rate of patients with resectable GCTB after neoadjuvant denosumab treatment was 80%; 44% of patients who had surgery underwent a less morbid procedure; and 37% of patients required no surgery. Denosumab brings effective long-term disease control benefits to patients with unresectable GCTB with a 5-year progression-free survival (PFS) rate of 88%.
Denosumab has freed patients from the pain of repeated surgery, controlled the disease progression and effectively improved the prognosis and life quality...
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