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January 29, 2017

UK MHRA recommends Roche’s new immunotherapy atezolizumab for bladder cancer

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has given a positive scientific opinion for Roche’s new immunotherapy, atezolizumab, which is accessible for patients with an incurable form of bladder cancer.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has given a positive scientific opinion for Roche’s new immunotherapy, atezolizumab, which is accessible for patients with an incurable form of bladder cancer.

Atezolizumab is a cancer immunotherapy and disarms the cancer by blocking programmed death ligand-1 (PD-L1), allowing the body's immune system to detect and destroy it.

It is being trialled as a treatment for various other cancers, alone and in combination, including colorectal cancer, breast cancer, renal cell carcinoma, small-cell lung cancer, other solid tumours, diffuse large B-cell lymphoma and paediatric cancers.

With the approval granted under the Early Access to Medicines Scheme (EAMS), patients and doctors will obtain access to new treatments for serious medical conditions.

The EAMS scheme aims to provide patients with life threatening or seriously debilitating conditions access to medicines that are not yet authorised for marketing.

"This is an area that has seen little advance and here we have a new treatment that has the potential to make a significant difference to the lives of patients."

Roche UK general manager Richard Erwin said: “This is an area that has seen little advance and here we have a new treatment that has the potential to make a significant difference to the lives of patients.

“This decision is truly a best practice example of how we can work together with healthcare bodies to make a drug currently going through marketing authorisation available to a much needed patient population.”

MHRA has fast-tracked atezolizumab for patients with locally advanced or metastatic urothelial carcinoma, after disease progression following one platinum-containing chemotherapy regimen before.

Bladder cancer Urothelial carcinoma accounts for more than 90% of bladder cancers in the UK, and develops from the cells of the bladder lining.


Image: Transitional cell carcinoma of the bladder. The white in the bladder is contrast. Photo: courtesy of James Heilman, MD.

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