European manufacturing facility to strengthen gene therapy supply
The new manufacturing facility in Finland will aid global supply of the first FDA-approved intravesical non-replicating gene therapy for adults with a common cancer.
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The new manufacturing facility in Finland will aid global supply of the first FDA-approved intravesical non-replicating gene therapy for adults with a common cancer.
The drug delivery system provides local release of erdafitinib and may offer an alternative treatment for eligible bladder cancer patients with limited options.
New data from a Phase III gene therapy trial has demonstrated a 90 percent three-year overall survival rate for its participants with a high-risk bladder cancer.
If approved, Roche’s Tecentriq subcutaneous (SC) would be the EU’s first injectable PD-(L)1 cancer immunotherapy.
Phase IIb study results show evidence of sustained, durable complete responses beyond one year with an intravesical gemcitabine delivery system for a high-risk bladder cancer.
A study has shown an intravesical sustained-release chemotherapy device demonstrated effectiveness in advanced bladder cancer.
The first gene therapy for high-risk non-muscle-invasive bladder cancer has been approved by The US Food and Drug Administration (FDA).
Mount Sinai researchers reveal that, in a Phase I trial, their personalised cancer vaccines targeting cancer neoantigens showed some early signs of potential benefit.
If the proof-of concept trial of AVA6000 Pro-doxorubicin is successful, it could lead to a pipeline of pro-drug chemotherapies with limited toxicity, say the drug's developers.
A Phase III trial concluded that avelumab is an effective maintenance therapy for patients with advanced or metastatic urothelial carcinoma, whose disease had not progressed after chemotherapy.
The UK MHRA has given a positive scientific opinion for Merck and Pfizer's avelumab on the Early Access to Medicines Scheme (EAMS).
The UK NICE has not found pembrolizumab cost-effective for use on the NHS, after a review of evidence collected while the drug was available via the Cancer Drugs Fund.
FDA Breakthrough Therapy Designation has been granted to PADCEV™ in combination with pembrolizumab in first-line advanced bladder cancer.
Keytruda is the first anti-PD-1 monoclonal antibody therapy approved for patients with BCG-unresponsive, high-risk, non-muscle invasive bladder cancer.
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