An established blood cancer drug is now available in a subcutaneous form, cutting the administration time from two hours to five minutes.

The subcutaneous (SC) form of Roche’s MabThera (rituximab), used to treat non-Hodgkin lymphoma (NHL), could improve patient experience while freeing up time in chemotherapy suites.

MabThera SC uses a new biological technology from Halozyme that locally and reversibly breaks down sub-skin tissues.

The SABRINA phase III trial compared the effects of MabThera SC and MabThera IV in patients with previously untreated follicular lymphoma.

It proved the non-inferiority of MabThera SC, with an objective response rate (proportion of patients whose cancer shrinks by over 50%) of 90.5% for SC and 84.4% for IV.

Roche has applied to the European Medicines Authority (EMA) for an updated licence to allow NHL patients in the UK to receive MabThera SC.

MabThera IV is the standard treatment for NHL. In MabThera SC the drug is combined with the human enzyme hyaluronidase, which temporarily increases the penetrability of the tissue layer under the skin, allowing rapid absorption.

Dr Andrew Davies, Consultant in Medical Oncology at the University of Southampton, said: “This is a new formulation of a drug we are very familiar with and have been using for many years. In Southampton, we have observed a high degree of patient preference and satisfaction with this new formulation of rituximab.”

NHL is one of the most common cancers in elderly people; over 12,200 people are diagnosed with it each year in the UK.

Halozyme has four technology partnerships involving the use of hyaluronidase to facilitate SC injections. Its partnership with Roche has also produced an SC version of Herceptin.

The company’s other partnerships to exploit this technology are with Baxter Healthcare, ViroPharma and Intrexon.

An easily injectable formulation of Roche’s breast cancer drug Herceptin has been shown to be as safe and effective as the intravenous version now available.

The new version of Herceptin (trastuzumab), available via subcutaneous (SC) injection, reduces the drug’s administration time from 30 to five minutes.

UK patients who are eligible for the SC formulation could be treated more rapidly, freeing up capacity in hospital chemotherapy facilities.

The HannaH trial compared Herceptin SC with Herceptin IV in 596 women with untreated HER2-positive early-stage breast cancer.

The study met its primary endpoint of ‘non-inferiority’ for pharmacokinetics and success in tumour eradication, and there were no new safety concerns.

Breast cancer is the most common cancer in the UK, with more than 48,000 newly diagnosed patients and 12,000 fatalities in 2008.

Herceptin is a targeted drug that blocks the function of HER2, a protein produced by a gene with cancer-causing potential. It uses the body’s immune system to destroy the tumour cells.

In 15% of women with breast cancer, increased quantities of the HER2 receptor are present on the tumour cells. HER2-positive breast cancer is associated with relatively poor survival rates.

Herceptin is indicated in Europe for the treatment of early-stage and metastatic breast cancer and metastatic gastric cancer. It is currently approved in an IV formulation only.

Herceptin SC uses a specialised technology to break down the skin barrier to drugs, enabling the subcutaneous injection of large volumes of medication.

Dr Mark Verrill, Consultant Medical Oncologist at Freeman Hospital, Newcastle Upon Tyne, commented: “The result of the HannaH trial is good news, particularly for patients. Herceptin is the standard of care, so the ability to deliver the drug in approximately five minutes without the need to secure intravenous access makes the treatment far more convenient.

“Aside from the benefit for patients, Herceptin SC has the potential to ease capacity at busy chemotherapy day units and may facilitate treatment close to home, resonating with the Cancer Reform Strategy.”

Roche is the world’s largest biotechnology firm, specialising in the development of personalised medicines for oncology, virology, inflammation, metabolism and CNS disorders.

Roche’s rheumatoid arthritis (RA) drug RoActemra has shown greater effectiveness than Abbott’s market-leading rival Humira in a phase IV clinical test.

The ADACTA head-to-head study indicated that RoActemra (tocilizumab) performed better on all primary and secondary measures of clinical efficacy than Humira (adalimumab).

The trial result will boost Roche’s attempts to win market share for RoActemra, whose sales rose to $675m last year – a long way behind Humira’s $7.9bn.

Preliminary analysis showed a similar safety profile for the two drugs.

However, the antibody RoActemra is only available via an hour-long intravenous infusion, whereas Humira and other TNF inhibitors can be administered by subcutaneous injection.

Roche is developing a subcutaneous injection version of RoActemra, which will be filed for regulatory approval later this year.

The ADACTA study showed that patients given RoActemra achieved a significantly greater reduction in disease activity after 24 weeks than those given Humira.

RoActemra also performed better on key secondary endpoints including remission and low disease activity.

The finding reflects the growing importance of phase IV (head to head) trials in a pharmaceutical market driven by value-based pricing.