FDA accepts new application for gel drug UGN-101 to treat patients with low-grade urinal skin cancer

UTUC usually refers to cancerous cells in the urinary tract at the urinary tract site on the kidneys and urethra, and is one of the most common types of bladder cancerIt has a high risk of local recurrence and is likely to be transferredAbout 5% to 10% of urinary tract cancers belong to UTUCCurrently, there is no FDA-approved non-surgical therapy for UTUCUGN-101 is a gel drug developed by UroGen, whose active ingredient is fissionUGN-101 can be dripped to the patient's lesions via standard intra-bladder catheters, and UroGen's special formula is liquid at room temperature, but condenses into semi-solid at body temperatureThis feature maintains the continuous release of the drug in the lesions, allowing the urinary tissue to be exposed to the effects of fission for a long time, thus using non-surgical methods to remove the tumorUGN-101 has been awarded the FDA's fast-track qualification and the treatment of LG UTUC's orphan drug, as well as the ground-breaking treatment designation's unique formulation of UroGen (RTGel) is able to maintain the concentration of the drug in the target tissue (Photo: UroGen's website)the application for the new drug is based on UGN-101's performance in a key Phase 3 clinical trial called OLYMPUSThe results of the trial showed that 59% of patients treated with UGN-101 achieved complete remission (CR) in the total intended treatment groupAccording to the Kaplan-Meier analysis, 89 percent of patients had a 6-month remission duration (DOR) and 84 percent of patients had a DOR of 12 monthsThe median recurrence time of the patient was 13 monthsIn subgroups of patients who could not surgically remove tumors, the ratio of CR to DOR to 12 months was the same as in the total intended treatment group"The FDA's acceptance of the UGN-101 application for a new drug and the granting of UGN-101 priority review eligibility is an important milestone in our efforts to develop new therapies to improve care for patients with cancer and urology," said Liz Barrett, President and CEO of UroGenStandard treatments are nephrology and repetitive endoscopic tumor excisionThey are in urgent need of a non-surgical treatment to reduce their medical burden "
References: New Drug Application (NDA) for UGN-101 Retrieved December 19, 2019, from https:// Original title: Courier - Reduces The Burden of Surgery for Patients, Bladder Cancer Breakthrough Therapy Is Eligible for Priority Review