Ikena Oncology's IK-175 Receives FDA Fast Track Designation for Advanced Urothelial Carcinoma

Ikena Oncology, Inc. is a targeted oncology company that focuses on patient-directed cancer treatment has received Fast Track designation from the FDA for its drug IK-175, a novel aryl hydrocarbon receptor antagonist. This drug is intended to be used in combination with immune checkpoint inhibitors to treat advanced urothelial carcinoma patients who have progressed on or within 3 months of receiving the last dose of checkpoint inhibitors.

Publish Date: 06-03-2023 Source: Ikena Oncology, Inc.

Urothelial carcinoma (UCa) comprises bladder cancer, accounting for 90-95% of UCa cases, and upper tract urothelial carcinoma (UTUCa), which includes the remaining 5-10%. UCa is considered advanced when UCa has spread to lymph nodes or distant organs like the lungs, bones, or liver. Most advanced UCa originates from non-papillary muscle-invasive tumors, which are now one of the highest mutation rates among cancers. Advanced UTUCa, on the other hand, has a distinct mutation profile and is frequently marked by mutations in FGFR3, KMT2D, PIK3CA, and TP53. Symptoms of advanced urothelial cancer may include blood in the urine, frequent urination, painful urination, lower back pain, fatigue, and weight loss. Despite the availability of multimodality therapy, advanced bladder cancer has a very low overall survival (OS) rate. Progression-free survival rates after first- and second-line treatments for advanced urothelial carcinoma indicate that females face a higher risk of progression than males. The median overall survival for these patients ranges from 12 to 14 months.

The incidence of locally advanced or metastatic UC in the USA was 3.8 per 100,000.

However, the current Locally Advanced or Metastatic Urothelial Cancer treatment market share, market uptake, and attribute analysis concerning the most potential emerging therapies (BT8009, Durvalumab, 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 the Locally Advanced or Metastatic Urothelial Cancer treatment. The key companies in the advanced development stage are Bicycle Therapeutics plc, AstraZeneca, etc..

Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market outlook forecast report on Locally Advanced or Metastatic Urothelial Cancer 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 2021 to 2032.

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