Nephrectomy

Junshi Biosciences Announces Approval of the sNDA for Toripalimab for the 1st-Line Treatment of Renal Cancer

Retrieved on: 
Sunday, April 7, 2024
Diagnosis, OS, Nephrectomy, Immunotherapy, DCR, Oncology, Risk, Patient, Shanda, Malignancy, Death, IMDC, Carcinoma, Renal cell carcinoma, Trial of the century, RCC, National Medical Products Administration, ESMO, HKEX, IRC, PFS, Annals of Oncology, Axitinib, Independent Review Committee, Pharmaceutical industry

Renal carcinoma is the third most common malignancy of the urinary system globally, and RCC accounts for 80%~90% of all cases of renal carcinoma.

Key Points: 
  • Renal carcinoma is the third most common malignancy of the urinary system globally, and RCC accounts for 80%~90% of all cases of renal carcinoma.
  • There were approximately 77,000 new cases of and 46,000 deaths due to renal carcinoma in China in 2022.
  • Distant metastasis occurred in about one-third of renal carcinoma patients at initial diagnosis, and in 20%-50% of localized patients after nephrectomy.
  • “The approval of toripalimab combined with axitinib addresses the gap in first-line immunotherapy for renal cancer in China.

UroGen Pharma Delivers Double Digit JELMYTO® Growth and Prepares for the Next Phase of the Company with on Track Rolling Submission of UGN-102

Retrieved on: 
Thursday, March 14, 2024
Oncology, Health, FDA, Clinical Trials, Pharmaceutical, Biotechnology, Research, Biopsy, Conference, Carcinoma, Chemistry, Webcast, New Drug Application, Medac, Patient, Mitomycins, NDA, CMC, Software, Safety, Nephrectomy, Patent, Medicare, Investment, RTW, ATLAS, Ureteroscopy, Gesellschaft mit beschränkter Haftung, Food, Pharmaceutical industry

The first part of the submission was the Chemistry, Manufacturing and Controls (CMC) sections.

Key Points: 
  • The first part of the submission was the Chemistry, Manufacturing and Controls (CMC) sections.
  • The FDA indicated that evaluation of duration of complete response at 12-months from the pivotal ENVISION trial will be sufficient to support submission of the NDA.
  • The company plans to complete the submission in September 2024 with a potential FDA decision as early as the first quarter of 2025.
  • Generated annual net product revenue of $82.7 million in 2023, compared with $64.4 million in 2022 in representing ~28% annual growth.

Summary of opinion: Keytruda, 22/02/2024 Positive

Retrieved on: 
Sunday, March 10, 2024
Carboplatin, GEJ, Hodgkin lymphoma, Patient, HNSCC, Cervical cancer, Ageing, CHL, Colorectal cancer, ALK, BTC, Head, Large intestine, Neck, Committee, Recurrence, IIC, Marketing, RCC, Renal cell carcinoma, Cancer, TPS, CHMP, Trastuzumab, TNBC, Paclitaxel, ASCT, Axitinib, Transitional epithelium, NSCLC, Lung cancer, European Commission, EGFR, Cholangiocarcinoma, Medication package insert, CRC, Neoplasm, Radiation, Cisplatin, Civil service commission, Pembrolizumab, Endometrial cancer, Nephrectomy, Platinum, MSI-H, Pemetrexed, Bevacizumab, Risk, Transitional cell carcinoma, CPS, PD-L1

Summary of opinion: Keytruda, 22/02/2024 Positive

Key Points: 


Summary of opinion: Keytruda, 22/02/2024 Positive

Merck’s KEYTRUDA® (pembrolizumab) Reduced the Risk of Death by 38% Versus Placebo as Adjuvant Therapy for Patients With Renal Cell Carcinoma (RCC) at an Increased Risk of Recurrence Following Nephrectomy

Retrieved on: 
Saturday, January 27, 2024
Research, FDA, Clinical Trials, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Other Science, MSD, Dana–Farber Cancer Institute, Renal cell carcinoma, Death, VEGF, Patient, M1, OS, RCC, Harvard Medical School, ASCO, Survival, DFS, Medicine, Society, NED, Cancer, Nephrectomy, Kidney, Risk, Recurrence, Disease, Safety, Eisai, Merck & Co., CPS, Rated R, MRK, Pharmaceutical industry

At 48 months, the estimated OS rate was 91.2% for patients who received KEYTRUDA compared to 86.0% for patients who received placebo.

Key Points: 
  • At 48 months, the estimated OS rate was 91.2% for patients who received KEYTRUDA compared to 86.0% for patients who received placebo.
  • Treatment-related adverse events (TRAEs) occurred in 79.1% of patients (n=386) in the KEYTRUDA arm and 53.0% of patients (n=263) in the placebo arm.
  • Grade 3-4 TRAEs occurred in 18.6% of patients in the KEYTRUDA arm and 1.2% of patients in the placebo arm.
  • Treatment-related adverse events resulting in discontinuation of any treatment occurred in 18.2% of patients in the KEYTRUDA arm and 0.8% of patients in the placebo arm.

UroGen Pharma Reports Third Quarter 2023 Financial Results

Retrieved on: 
Tuesday, November 14, 2023
Biotechnology, Pharmaceutical, Health, Oncology, NDA, Medicine, Webcast, Rated R, NMIBC, RTW, Chemistry, Risk, TURBT, Patient, Investment, Probability, Research, Carcinoma, LG, FDA, Mitomycins, Conference, ATLAS, Software, Death, CMC, Nephrectomy, Growth, CRR, Recurrence, URS, Role, Pharmaceutical industry, Medical imaging, Dietary supplement, Video game, Agency

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced financial results for the third quarter ended September 30, 2023, and provided an overview of recent developments.

Key Points: 
  • UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced financial results for the third quarter ended September 30, 2023, and provided an overview of recent developments.
  • “During the third quarter, UroGen achieved several notable milestones, including announcement of unprecedented positive results from our ENVISION and ATLAS Phase 3 trials of UGN-102 in LG-IR-NMIBC,” said Liz Barrett, President, and Chief Executive Officer of UroGen.
  • Activated sites on November 1, 2023 were 1,088, compared to 1,058 on August 1, 2023, while repeat accounts on November 1, 2023 were 296, compared to 267 on August 1, 2023.
  • Third Quarter 2023 Financial Results:
    JELMYTO Revenue: UroGen reported net product revenue of JELMYTO for the third quarter 2023 of $20.9 million, compared to $16.1 million in the third quarter of 2022.

KEYTRUDA® (pembrolizumab) Significantly Improved Overall Survival (OS) Versus Placebo as Adjuvant Therapy for Certain Patients With Renal Cell Carcinoma (RCC) Following Nephrectomy

Retrieved on: 
Wednesday, November 1, 2023
Biotechnology, Pharmaceutical, Health, Clinical Trials, MSD, Survival, NYSE, ESMO, Renal cell carcinoma, II, Congress, Head, MRK, European Society for Medical Oncology, Rated R, RCC, Society, DFS, Data monitoring committee, Nephrectomy, Disease, Merck & Co., Risk, Recurrence, Oncology, Lung cancer, Cancer, European, Patient, OS, Death, Pharmaceutical industry, Merck

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the Phase 3 KEYNOTE-564 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, met its key secondary endpoint of overall survival (OS), for the adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

Key Points: 
  • Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the Phase 3 KEYNOTE-564 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, met its key secondary endpoint of overall survival (OS), for the adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
  • At a pre-specified interim analysis review conducted by an independent Data Monitoring Committee, KEYTRUDA demonstrated a statistically significant and clinically meaningful improvement in OS compared to placebo.
  • The safety profile of KEYTRUDA was consistent with that observed in previously reported studies; no new safety signals were observed.
  • Results will be presented at an upcoming medical meeting and submitted to regulatory authorities.

UroGen Pharma Reports Record JELMYTO Quarterly Sales and Recent Corporate Developments

Retrieved on: 
Thursday, August 10, 2023
Biotechnology, Pharmaceutical, Health, Oncology, Database, Biopsy, Investment, Software, Nephrectomy, NDA, RDF, Rated R, Mitomycins, URS, Journal, Patient, Risk, RTW, Webcast, Growth, LG, Research, Urology, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Recurrence, Death, Food, Conference, The Journal of Urology, ATLAS, Pharmaceutical industry, Video game, Security (finance), Bank, TURBT

“We are in a transformative period for UroGen,” said Liz Barrett, President and Chief Executive Officer of UroGen Pharma.

Key Points: 
  • “We are in a transformative period for UroGen,” said Liz Barrett, President and Chief Executive Officer of UroGen Pharma.
  • UroGen hosted an event to discuss and highlight topline results from the Phase 3 ATLAS and ENVISION clinical trials on July 27th, 2023.
  • Generated record quarterly net product revenue of $21.1 million for the second quarter of 2023, representing ~27% growth over the second quarter of 2022.
  • The rate applied to cash payments incurred in 2023 is 13% based on global net product sales of JELMYTO in 2022.

Junshi Biosciences Announces Acceptance of the Supplemental New Drug Application for Toripalimab

Retrieved on: 
Wednesday, July 12, 2023
TKI, Malignancy, Renji Hospital, RCC, Clinical trial, Hope, Nephrectomy, Immunotherapy, PFS, Kidney, Shanghai Jiao Tong University School of Medicine, Global Research, Chinese, Death, Development, SSE, Chinese Medical Journal, HIV disease progression rates, Patient, Risk, National Medical Products Administration, IMDC, Carcinoma, Diagnosis, Axitinib, ORR, Safety, Disease, Pharmaceutical industry

Therefore, the need for new treatment options is more urgent for patients with medium and high-risk advanced RCC compared to low-risk patients.

Key Points: 
  • Therefore, the need for new treatment options is more urgent for patients with medium and high-risk advanced RCC compared to low-risk patients.
  • This supplemental new drug application is mainly based on the RENOTORCH study (NCT04394975).
  • The safety profile of toripalimab in the study was consistent with known risks, and no new safety signals were identified.
  • Dr. Jianjun ZOU, the Global Research and Development President of Junshi Biosciences, expressed her enthusiasm regarding the acceptance of this application.

Retrospective Study Finds JELMYTO® Use Effective Following Partial Ablation or Biopsy in Larger Volume Low-Grade Upper Tract Urothelial Tumors that Impede Kidney Preservation

Retrieved on: 
Monday, July 10, 2023
Science, Biotechnology, Research, Pharmaceutical, Oncology, General Health, Health, Clinical Trials, Neoplasm, Nephrectomy, RDF, Associate, Mitomycins, URS, UTUC, Patient, Role, Biopsy, Pharmaceutical industry, Medical imaging, Nursing, Urology

This study assessed the efficacy of JELMYTO in managing patients with larger volume disease where initial tumor burden may not be amenable to complete mechanical ablation or renal preservation.

Key Points: 
  • This study assessed the efficacy of JELMYTO in managing patients with larger volume disease where initial tumor burden may not be amenable to complete mechanical ablation or renal preservation.
  • The goal of this study was to explore alternatives to nephroureterectomy for patients with higher-volume low-grade disease to preserve kidney function and minimize complications.
  • This study aimed to determine if higher volume, low-grade upper tract urothelial tumors (LG-UTUC) patients could achieve disease-free status by undergoing partial ablation or biopsy only before treatment with JELMYTO during the initial ureteroscopy (URS) procedure.
  • Among the 112 renal units evaluated, 50 underwent complete ablation, 42 underwent partial ablation and 20 underwent biopsy only.

AVATAR MEDICAL Receives FDA Clearance For its Virtual Reality Surgical Planning Solution

Retrieved on: 
Tuesday, June 6, 2023
FDA, Health Technology, Telemedicine, Virtual Medicine, Data Management, Technology, Radiology, Surgery, Apps, Applications, Biometrics, Medical Devices, Wearables, Mobile Technology, Other Technology, Biotechnology, Software, Health, Columbia University, CT, CUNY, Surgeon, Education, Kidney cancer, University, Multimedia, Research, Nephrectomy, Associate, VR, AVATAR, MRI, Interventional radiology, Hospital, Patient, Machine learning, Institut Pasteur de Dalat, Virtual reality, XR, Regulation of tobacco by the U.S. Food and Drug Administration, Pasteur Institute, Food, Medical imaging, University of Massachusetts, Medtech

Medtech startup AVATAR MEDICAL announced today that its virtual reality (VR) surgical planning solution has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

Key Points: 
  • Medtech startup AVATAR MEDICAL announced today that its virtual reality (VR) surgical planning solution has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).
  • (Photo: Business Wire)
    AVATAR MEDICAL helps surgeons better prepare their procedures through the use of virtual reality (VR) representations of their patients.
  • They serve as valuable tools for pre-operative planning and can also be displayed during surgical procedures.
  • We expect European medical device certification for next year”, says Xavier Wartelle, CEO of AVATAR MEDICAL.