Blood cancer injection given green light
pharmafile | August 5, 2014 | News story | Research and Development, Sales and Marketing | MabThera, Roche, follicular lymphoma and small lymphocytic lymphoma
Roche has launched a new injection formulation of its blood cancer drug MabThera (rituximab) to treat patients with follicular lymphoma, a common type of blood cancer.
The new subcutaneous formulation of its drug can now administered in an injection just under the skin and takes around five minutes, compared to the current two and half hours through intravenous infusion.
The faster way of treating follicular lymphoma (FL), a form of non-Hodgkin lymphoma, has been approved in the UK following the SABRINA clinical study that showed comparable efficacy and similar overall response rates compared to traditional IV MabThera.
Roche estimates that it will be available to around 2,400 patients per year. NHS England has confirmed that it will pay for the drug; the IV version on MabThera has already been recommended for funding by NICE.
As well as reducing pressure on busy chemotherapy units, the new injection will also help cut costs, according to Roche, which estimates the new form of MabThera could save the NHS more than £2.5 million a year.
This, it says in a statement, is due to savings in national tariffs, as well as overall drug costs and reduced wastage.
A 50ml vial of the medicine currently costs the NHS £873 in IV form, according to the BNF. Other treatments for this type of blood cancer on the NHS include Napp’s chemotherapy agent Levact (bendamustine) that costs £275 for a 100mg vial, as well as GSK’s now off patent Leukeran (chlorambucil) pills, which costs £8 for a 25-pack of tablets.
Dr Andrew Davies, a consultant in Medical Oncology at University Hospital Southampton who has also led Roche-sponsored trials of MabThera, says: “The number of new cancer cases in the UK is expected to rise by 45% between 2007 and 2030. This increasing demand for chemotherapy units places resources under tremendous pressure. “
“The injectable form of MabThera is an innovative new formulation that can help us make more efficient use of resources and improves the experience of our patients,” he adds.
MabThera works by targeting a protein called CD-20 that is found on B-cell lymphocytes. The drug kills these cells while allowing normal white blood cells to grow and replace those destroyed.
The blockbuster drug, also used to treat rheumatoid arthritis, earned Roche $7.4 billion in 2013 and the drug maker are counting on this new formulation to extend its shelf life following the loss of patent protection in Europe at the end of 2013.
It is the second subcutaneous version of an existing cancer drug Roche has launched following the approval of Herceptin SC to treat breast cancer in September last year.
As the blood cancer market heats up Roche are relying upon a strategy of developing ‘biobetter’ drugs to replace their existing portfolio and fend off competition from biosimilar copies of MabThera.
In July, the European commission approved Roche’s new leukaemia drug Gazyvaro (obinutuzumab) for patients with untreated chronic lymphocytic leukaemia. The company is now hoping to manoeuvre it into the market as a next-gen version of MabThera.
Emily MacKenzie
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