NDA initiated with US FDA for TAR-200 for patients with BCG-unresponsive high-risk NMIBC
“Upon approval, TAR-200 promises to be a meaningful additional treatment option for certain patients with NMIBC, addressing a critical need for people who have had relatively limited therapeutic alternatives. Many patients face life-altering surgical options such as radical cystectomy, which is complete bladder removal,” said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Head, Oncology, Johnson & Johnson Innovative Medicine. “By combining our expertise in innovative medicine and medical devices, Johnson & Johnson is uniquely positioned to transform how we treat certain types of bladder cancer through the first and only intravesical drug releasing system for this disease. We look forward to working with the FDA in review of this application.”
Share:
More News
“Our goal is not simply to complete a Phase 1 trial; it is to deliver a re-sensitization solution that changes the post-progression treatment paradigm and positions Kairos as the essential complement to the EGFR-targeted therapy market with this clean safety profile now confirmed across 13 patients,” said Dr. John Yu,
Dr. Michael GE, CEO of Kelun-Biotech, stated: “We are delighted to see that sac-TMT combined with pembrolizumab has achieved exciting positive results compared with immunotherapy plus chemotherapy in the first-line treatment of patients with PD-L1-negative NSCLC. This ADC plus immunotherapy regimen has previously demonstrated superior efficacy over immunotherapy monotherapy in
“This Fast Track designation represents another important regulatory milestone for Oncolytics and reflects the significant progress we have made over the past twelve months in advancing pelareorep toward potential registration,” said Jared Kelly, Chief Executive Officer of Oncolytics. “During that time, we have received Fast Track designation in both metastatic
“These findings build upon the well-established role of KEYTRUDA in endometrial cancer, one of the few cancers with rising incidence rates,” said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories. “We are committed to helping women facing this disease by advancing potential treatment options. We thank the