DualityBio's DB-1303 Granted Fast-Track Status by FDA for Advanced Endometrial Cancer Treatment

Duality Biologics has announced that the FDA has granted Fast Track Designation to DB-1303, a novel antibody-drug conjugate, for the treatment of advanced, recurrent or metastatic endometrial carcinoma with HER2 overexpression that has progressed after standard treatment. DB-1303 is a novel antibody-drug conjugate designed to target both HER2-positive and HER2-low tumors with potent anti-tumor activity, bystander killing effect, high plasma stability, low free payload in circulation, and wide therapeutic index

Publish Date: 21-01-2023 Source: Duality Biologics

Endometrial carcinoma (EC) or Uterine serous carcinoma (USC) is the most common gynecologic malignancy and will be encountered by almost every gynecologist. The most common symptoms are abnormal uterine bleeding and vaginal discharge. Patients with advanced disease may have symptoms similar to those seen with advanced ovarian cancer, such as abdominal or pelvic pain, abdominal distension, early satiety, or a change in bowel or bladder function. Prolonged unopposed estrogen exposure is associated with most type I endometrial cancers. Estrogen replacement therapy prescribed to control menopausal symptoms increases the risk of developing endometrial cancer by 2- to 20-fold, with an increasing risk correlating with the duration of use. Reproductive characteristics associated with an increased risk of endometrial cancer include nulliparity, infertility, early age of menarche, and late age of menopause. The estimated cumulative risk of developing endometrial cancer by age 70 is 54% for MLH1, 21% for MSH2, and 16% for MSH6 mutations.

The incidence of Endometrial carcinoma ranges from 15 to 18 cases per 100,000 population in the USA.

However, the current Advanced and Metastatic Endometrial Carcinoma treatment market share, market uptake, and attribute analysis concerning the most potential emerging therapies (Doctaxel, Selinexor, ELU001, SYD985, etc.) has been provided under the market outlook section of the study covering 8 MM countries; The United States, EU5 (Germany, Spain, France, Italy, UK) Japan and China.

In terms of pharmacologic therapies, several pharmaceutical products are being approved and under different phases of development for Advanced and Metastatic Endometrial Carcinoma treatment. The key companies in the advanced development stage are Boryung Pharmaceutical Co., Ltd, Ipsen, Elucida Oncology, etc.

Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market outlook forecast report on Advanced and Metastatic Endometrial Carcinoma to provide a clear understanding of disease area background, epidemiology, current and future competitions, the country-specific standard of care, and the complete market forecast for 2022 to 2032.

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