Healthcare products company Johnson & Johnson (J&J) (NYSE:JNJ) announced on Wednesday that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for TAR-200 for the treatment of BCG-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC).
The FDA is reviewing the application through its Real-Time Oncology Review (RTOR) programme for faster approval.
TAR-200 is the first and only intravesical drug releasing system for this condition and offers an alternative to radical cystectomy, a surgery that removes the entire bladder.
Clinical data from the Phase 2b SunRISe-1 study showed an 83.5% complete response rate with high durability.
TAR-200 is administered in an outpatient setting and has a low rate of severe side effects.
The FDA granted Breakthrough Therapy Designation to TAR-200 in December 2023.
Amgen's LUMAKRAS (sotorasib) in combination with Vectibix (panitumumab receives US FDA approval
Telix Pharmaceuticals' Illuccix gets European approval
Innovent and ASK Pharm's limertinib NDA receives Chinese regulatory approval
RYBREVANT approved in Canada for second-line EGFR-mutated lung cancer
Avacta Group reports positive data from AVA6000 Phase 1 trial in salivary gland cancer
Axcynsis Therapeutics' IND for AT03-65 receives US FDA approval
Innovent Biologics' IBI343 receives Breakthrough Therapy Designation in China
OS Therapies reports positive Phase 2b data for OST-HER2 in lung metastatic osteosarcoma
Johnson & Johnson submits New Drug Application for TAR-200 to treat bladder cancer
Creo Medical Group plc launches robotic-guided lung ablation procedures in the UK
Phase I/II clinical trial of Ariceum Therapeutics' 225Ac-SSO110 gets US FDA approval
Adaptive Biotechnologies and NeoGenomics partner to expand MRD monitoring for blood cancer
HUTCHMED receives full NMPA approval for ORPATHYS in China for MET exon 14 skipping NSCLC
Vascarta collaborates with City College of New York to improve efficacy and safety of chemotherapy