Bladder Cancer

FerGene Appoints Top Biotech Leaders to Executive Team

Retrieved on: 
Wednesday, June 17, 2020
Oncology, Health, Other Science, Pharmaceutical, Science, Biotechnology, Oncology, Bladder cancer, Bladder Cancer, FerGene

FerGene, Inc., a privately held gene therapy company dedicated to revolutionizing the treatment of bladder cancer, today announced the appointment of top biotech leaders to its executive team.

Key Points: 
  • FerGene, Inc., a privately held gene therapy company dedicated to revolutionizing the treatment of bladder cancer, today announced the appointment of top biotech leaders to its executive team.
  • Were thrilled to welcome these phenomenal leaders to our new company, said David Meek, Chief Executive Officer, FerGene.
  • Im very excited to join FerGene and fulfill our mission of helping patients with bladder cancer, said Mr. Bellete.
  • During the last 25 years, Dr. Kasturi has built a stellar career as a hematologist/oncologist and biotech executive dedicated to developing innovative treatment options for patients.

Merck Provides Update on Phase 3 KEYNOTE-361 Trial Evaluating KEYTRUDA® (pembrolizumab) as Monotherapy and in Combination with Chemotherapy in Patients with Advanced or Metastatic Urothelial Carcinoma

Retrieved on: 
Tuesday, June 9, 2020
Other Health, Research, General Health, Pharmaceutical, Oncology, Infectious diseases, Clinical trials, Science, Biotechnology, AIDS, Other Science, Health, Clinical medicine, Cancer treatments, Cancer, Lung cancer, Antineoplastic drugs, Breakthrough therapy, Carcinoma, Merck, Pembrolizumab, Merkel-cell carcinoma, Transitional cell carcinoma, Non-small-cell lung carcinoma, KEYNOTE-361, Bladder Cancer, Merck

KEYNOTE-361 (ClinicalTrials.gov, NCT02853305 ) is a randomized, open-label, Phase 3 trial evaluating KEYTRUDA as monotherapy and in combination with chemotherapy versus chemotherapy alone, the current standard of care, for the first-line treatment of advanced or metastatic urothelial carcinoma.

Key Points: 
  • KEYNOTE-361 (ClinicalTrials.gov, NCT02853305 ) is a randomized, open-label, Phase 3 trial evaluating KEYTRUDA as monotherapy and in combination with chemotherapy versus chemotherapy alone, the current standard of care, for the first-line treatment of advanced or metastatic urothelial carcinoma.
  • KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.
  • KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).
  • In KEYNOTE-052, KEYTRUDA was discontinued due to adverse reactions in 11% of 370 patients with locally advanced or metastatic urothelial carcinoma.

FDA Oncologic Drugs Advisory Committee (ODAC) Recommends KEYTRUDA® (pembrolizumab) for the Treatment of Certain Patients with High-Risk, Non-Muscle Invasive Bladder Cancer (NMIBC)

Retrieved on: 
Tuesday, December 17, 2019
Oncology, FDA, Health, Clinical trials, Pharmaceutical, Biotechnology, Cancer, Clinical medicine, RTT, Lung cancer, Bristol-Myers Squibb, Infectious causes of cancer, Breakthrough therapy, Non-small-cell lung carcinoma, Paclitaxel, Bladder cancer, Melanoma, Pembrolizumab, Bladder Cancer, KEYNOTE-057, KEYTRUDA® (pembrolizumab) Injection, 100mg, Merck

Approximately 75% of patients with bladder cancer are diagnosed with non-muscle invasive bladder cancer (NMIBC).

Key Points: 
  • Approximately 75% of patients with bladder cancer are diagnosed with non-muscle invasive bladder cancer (NMIBC).
  • KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.
  • KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.
  • Patients received KEYTRUDA for a median of 3 doses (range 117 doses), with 34 patients (85%) receiving 2 doses or more.

FDA Grants Priority Review to Merck’s Supplemental Biologics License Application (sBLA) for KEYTRUDA® (pembrolizumab) in Certain Patients with High-Risk, Non-Muscle Invasive Bladder Cancer (NMIBC)

Retrieved on: 
Monday, December 2, 2019
Oncology, Health, FDA, Hospitals, Clinical trials, Pharmaceutical, Biotechnology, RTT, Cancer, Clinical medicine, Bladder cancer, Melanoma, Pembrolizumab, Viralytics, Nivolumab, Bladder Cancer, KEYNOTE-057, KEYTRUDA® (pembrolizumab) Injection, 100mg, Merck

Merck is steadfast in its commitment to patients with bladder cancer, including advancing research to meet unmet medical needs.

Key Points: 
  • Merck is steadfast in its commitment to patients with bladder cancer, including advancing research to meet unmet medical needs.
  • We look forward to participating in the advisory committee meeting and to continuing to work with the FDA as they review this supplemental application for KEYTRUDA.
  • Approximately 75% of patients with bladder cancer are diagnosed with non-muscle invasive bladder cancer (NMIBC).
  • KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.