Johnson & Johnson anticancer drug erdafitinib obtained breakthrough drug qualification

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Medical Network March 27, the US pharmaceutical giant Johnson & Johnson (JNJ) recently announced that the US Food and Drug Administration (FDA) has granted the breakthrough drug qualification for the targeted anticancer drug erdafitinib in the treatment of metastatic urothelial carcinoma (mUC) ( BTD). Erdafitinib is a pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor (TKI) that is expected to be the first targeted drug for the treatment of mUC.
BTD is a new drug review channel created by the FDA in 2012 to accelerate the development and review of treatments for severe or life-threatening diseases and has preliminary clinical evidence that the drug can substantially improve the condition compared to existing treatments. New drug. Obtaining BTD's drugs will provide closer guidance, including senior FDA officials, during research and development to ensure that patients are offered new treatment options in the shortest possible time.
The FDA awarded erdafitinib BTD based on a multicenter, open-label, phase II clinical study BLC2001. The study was conducted in adult patients with locally advanced or metastatic UC with specific fibroblast growth factor receptor (FGFR) gene changes in the tumor to evaluate the efficacy and safety of erdafitinib. Data published at the ASCO Urogenital Tumor Symposium in 2018 showed total erdafitinib treatment in 59 patients with recurrent or refractory mUC who had a therapeutically instructive FGFR mutation in their tumors. The response rate was 42%.
At present, Johnson & Johnson's Yang Sen is conducting Phase II and Phase III clinical studies to evaluate the potential of erdafitinib in the treatment of patients with advanced UC. FGFRs are a family of receptor tyrosine kinases that may be up-regulated in various types of tumor cells, which may be involved in tumor cell proliferation and differentiation, tumor angiogenesis, and tumor cell survival. Johnson & Johnson reached an exclusive global licensing and cooperation agreement with Astex in 2008 to jointly develop and commercialize erdafitinib.
UC is the most common type of bladder cancer, accounting for approximately 90% of all bladder cancer cases. Patients in the advanced stage face very high rates of disease recurrence and exacerbation, leading to far-reaching medical needs in this area. Bladder cancer is the sixth most common cancer in the United States; bladder cancer is the ninth most common cancer worldwide. Most bladder cancers can be diagnosed at an earlier stage, but the rate of disease recurrence and exacerbation is very high. About 78% of patients will experience recurrence or worsening within 5 years. The survival rate depends on the stage and type of cancer. For patients with metastatic bladder cancer, the 5-year survival rate is only 5%.

Surface Active Agent TC-1000

I. Company profile

Tiancheng Chemical Co., Ltd. is a collectivized high-tech multi-function fine chemical enterprise, integrated with science, industry, trade and research, which is mainly engaged in paper chemicals, Water Treatment Chemicals, rubber and plastic chemicals, agricultural pharmaceutical intermediates, basic chemical materials, food additives, detergent additives and electronic chemicals.

II. Technical indicators:

Appearance

Colorless and transparent liquid

Content

60%

pH value

4-5.5

Viscosity (25℃), mPa·s

≤20

III. Application fields:

1. In the filed of cosmetics, detergents, wool detergents: With the continuous improvement of people`s living standards, the demand for cosmetics, washing products and cleaning products is continuously increasing. As a monomer, the surfactant is applied to many fields, but also use with non-ion preparations jointly, with the function of penetration, humidification, washing and electrostatic elimination, providing help and support for improvement of people`s life and quality of life.

2. In the field of electronic chemicals: the surfactant can be used in cleaning preparations of the electronic products, with the function of washing and electrostatic elimination.

IV. Notes:

1. Storage condition: This product is stored in a cool and dry place (5-30 ℃) to prevent open-air exposure and freezing.

2. If the product storage temperature is below -15 ℃, there will be crystalline polamer. Before using, please heat and stir evenly, not affecting the product quality.

3. The product is slightly acidic. If it is accidentally into the eyes, please wash with water immediately.

V. Packing specification

250 kg plastic drum; IBC tons of barrel; Flexitank.

Surface Active Agent TC-1000

Surface Active Agent Tc-1000,Surface Active Agent,Surface Active Agent For Electronic Chemicals

Shandong Tiancheng Chemical Co., Ltd. , https://www.tianchengchemical.com