The First Bladder Cancer Targeted Therapy Filed the Import Drug Clinical Trial Applications to Start the Road of Marketing in China

According to the CDE website, the Erdafitinib Tablets developed by Janssen under J & J has recently been filed the import drug clinical trial applications in China, which have been accepted, to start the road of marketing of this blockbuster bladder cancer drug in China. It is expected to bring an innovative targeted therapy for Chinese bladder cancer patients.

Source: CDE

Clinical demands that are far from satisfied

According to the Pathology and Genetics of Tumours of the Urinary System and Male Genital Organs of the WHO, bladder cancer types include bladder urothelial carcinoma, squamous cell carcinoma of the bladder, and adenocarcinoma of the bladder.

According to the FDA, bladder cancer is the sixth most common disease in the U.S., with about 15,000 new cases every year. The prognoses of metastatic disease patients, especially patients with relapsed or refractory diseases, are poor because of the rapid tumor progression and a lack of effective therapeutic methods. Take patients with stage IV metastatic bladder cancer for instance, their 5-year relative survival is only 5%; they urgently need new therapeutic methods to relieve the disease and prolong life. This area has significant medical needs that are far from satisfied.

The first metastatic bladder cancer targeted therapy approved by the FDA

The fibroblast growth factor receptor (FGFR) participates in regulating important physiological processes in vivo, including cell growth and division, etc. Gene mutations, etc. that occur in different tumors can lead to abnormal activation of the receptor to eventually promote tumor cells to be generated and proliferate. Developing new anticancer drugs with FGFR inhibitors as the breach has been a hot research area of cancer targeted therapies in recent years. According to statistics, about 1/5 of relapsed and refractory bladder cancer patients have FGFR changes.

Erdafitinib was originally developed by Astex Pharmaceuticals. Janssen reached global cooperation for erdafitinib with Astex in 2008 to obtain the development and commercialization rights in erdafitinib. Erdafitinib was granted the Breakthrough Therapy Designation for urothelium carcinoma by the FDA in Mar. 2018, and the marketing application of the new drug received the Priority Review Designation.

Erdafitinib Tablets was approved for marketing through the accelerated approval of the FDA in Apr. 2019, with the trade name of Balversa and the indication of locally advanced or metastatic bladder cancer that has progressed following platinum-containing chemotherapy, to become the world’s first targeted drug for metastatic urothelium carcinoma. Balversa is oral tablets, with 3mg, 4mg, or 5mg erdafitinib contained in each tablet. If you are looking for medical product suppliers of Erdafitinib Tablets, Pharmasources would be your best choice.

Registered clinical trial

It is reported that the FDA’s accelerated approval of the marketing application of erdafitinib was based on the effectiveness data of a Phase II clinical trial that enrolled 87 locally advanced or metastatic urothelium carcinoma patients who had FGFR3 gene mutation or FGFR gene fusion change and progressed following at least one line of prior platinum-containing chemotherapy.

According to the published clinical trial results, the objective response rate of patients receiving erdafitinib reached 32.2%, the complete response (CR) reached 2.3%, the partial response (PR) reached 29.9%, and the median response duration was 5.4 months.

Multi-indication clinical study

Given the extensive physiological processes the FGFR participates in regulating in vivo and the tumor formation and progression promotion of gene mutations in different types of tumors, FGFR inhibitor development can target different types of tumors from the perspective of therapeutic range and FGFR inhibitors have diverse potential indications.

According to the information disclosed in ClinicalTrials, the number of the clinical trials of erdafitinib disclosed is 17 in total, including 11 Phase II clinical trials and 1 Phase III clinical trial, involving indications including advanced malignant solid tumor, non-Hodgkin's lymphoma, prostatic cancer, non-small cell lung cancer, urothelium carcinoma, hepatocellular carcinoma, breast cancer, and relapsed/refractory multiple myeloma, etc.

The Phase III clinical trial of erdafitinib has been started in Mar. 2018, which plans to recruit 631 subjects, aims to compare the clinical efficacy of erdafitinib and chemotherapy drugs such as vincristine and docetaxel, and also pembrolizumab in treating urothelium carcinoma and is expected to end at the end of 2021.

About  the Author:    

Caicai, a Master of Pharmacy from Shanghai Jiaotong University, used to work in the Institute of Science and Technical Information. Currently as a practitioner in the drug surveillance system, she is good at interpreting industry regulations, pharmaceutical research developments, etc.