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.

Dainippon Sumitomo Pharma (DSP) is set to acquire biotechnology company Boston Biomedical Inc. (BBI), a specialist in drugs targeting cancer stem cells.

The Japanese company will pay $200m for BBI up front, with development milestone payments of up to US$540m on two new drugs (BBI608 and BBI503) and commercial milestone payments of up to $1.89bn based on sales.

BBI will become a 100% owned subsidiary of DSP and continue its operation in Massachusetts, US.

DSP aims to commercialise BBI608 and BBI503 in 2015 or later. The two new oral drug candidates are potentially the first anticancer drugs to target cancer stem cells, with the potential to treat refractory, recurrent and metastatic cancers.

BBI608 is currently entering a phase III clinical trial for colorectal cancer and is in phase Ib and II clinical trials for solid tumours. BBI503 is in a phase I clinical trial for advanced solid tumours.

The two companies’ relationship began in March 20011, when DSP signed an exclusive Product Option License agreement with BBI to develop and commercialise BBI608 in Japan for treatment of all types of cancer.

DSP plans to develop its pipeline for novel cancer therapies emerging from current biotechnology R&D.

Masayo Tada, President and CEO of DSP, said: “Acquisition of BBI is not only an acquisition of an innovative pipeline in the oncology area, it also represents obtaining an excellent drug discovery/development platform with the capabilities of BBI, enabling us to continuously create candidate compounds likely to advance into later development stages.

“Subsequently we intend to establish our R&D base in the US to expand our presence in cancer treatment globally.”

The acquisition is expected to close, following completion of antitrust procedures, in April 2012.

The European Commission has approved AstraZeneca’s drug Caprelsa for treatment of advanced medullary thyroid cancer (MTC).

The approval, which follows a CHMP recommendation in November 2011, makes Caprelsa (vandetanib) the first licensed treatment for MTC in Europe.

Caprelsa can now be used to treat patients with inoperable or metastatic MTC, who formerly had no alternative treatment option.

The CHMP recommendation was based on phase III trial data – including the ZETA study of 331 patients with advanced MTC, where the use of Caprelsa was associated with a 54% fall in disease progression relative to placebo.

The same trial helped Caprelsa to gain FDA approval in April 2011. The FDA requires AZ to complete a post-approval clinical trial to explore whether a lower dose would be effective, reducing the risk of serious side-effects (including stroke).

MTC, which originates from non-hormone producing cells, affects 5–10% of Europe’s 48,000 thyroid cancer patients.

The standard treatment option is a total thyroidectomy, removing all lymph nodes and fatty tissues from the central area of the neck. This is not always possible when the disease is advanced.

Reuters analysts predict that worldwide sales of Caprelsa will peak at around $128m in 2016.

The European Medicines Agency (EMA) has recommended the marketing authorisation of Roche’s drug Zelboraf (vemurafenib) as a treatment for metastatic or inoperable melanoma with BRAF V600 mutations.

The drug, a protein-kinase inhibitor, improves survival times in patients with advanced skin cancer by about three months relative to the standard existing treatment.

Zelboraf is a personalised medicine linked to Roche’s cobas BRAF Mutation Test, which selects patients for treatment with a number of specific anti-melanoma drugs.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Zelforaf outweighed the risk of causing secondary skin cancers, including squamous cell carcinomas.

While early-stage melanoma can be treated effectively by surgery, metastatic melanoma causes 15,000 deaths worldwide each year. Only a quarter of patients survive beyond 12 months.

In clinical trials, Zelboraf was found to improve progression-free survival times by around four months and overall survival times by about three months relative to the standard treatment (dacarbazine).

The CHMP decided that the risks of using Zelboraf were acceptably low, and that Roche had put in place an appropriate risk management procedure for doctors, including monitoring and treatment of secondary cancers.

Paul Brown, Head of Roche Molecular Systems, commented: “The cobas BRAF Mutation Test has improved sensitivity, accuracy and speed compared to other commonly used, unapproved detection methods. With a personalised medicine now available, all people diagnosed with inoperable or metastatic melanoma should be tested to help determine the best options for treatment.”

Zelboraf was approved by the FDA in August 2011.

The marketing authorisation for Zytiga (abiraterone acetate) has been approved by the European Commission after an accelerated regulatory review process by the EMA.

The androgen biosynthesis inhibitor has been approved for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) whose disease has progressed.

Professor Karim Fizazi, Department of Cancer Medicine, Institute Gustave Roussy, France, says its approval “gives new hope to men” suffering from the disease across Europe.

The fast-track review by the EMA followed a positive opinion by the CHMP in July.

Zytiga demonstrated in a pivotal Phase III study a 35.4% reduction in the risk of death and an improvement of almost four months in median overall survival.

“The efficacy, safety and ease of use of abiraterone acetate, a medicine that can be taken at home, will address an important unmet medical need for many patients, helping them to live longer with a better quality of life and less pain,” added Professor Fizazi.

Prostate is the third most common cause of cancer deaths in Europe. An estimated 370,000 new cases were diagnosed across Europe, resulting in the deaths of nearly £90,000 men.

NICE has failed to recommend three treatments for patients with metastatic colorectal cancer that has progressed following first-line chemotherapy.

According to the new draft guidance, Merck Serono’s Erbitux (cetuximab), Roche’s Avastin (bevacizumab) and Amgen’s Vectibix (panitumumab) failed to prove to NICE’s Independent Appraisal Committee that the treatment options were cost-effective.

Andrew Dillon, Chief Executive of NICE, said that six treatments for various stages of colorectal cancer are already recommended by NICE and at present, the Committee “does not feel it has enough clear evidence, especially in the case of bevacizumab, to be able to recommend these drugs for use on the NHS.”

The preliminary recommendations are now available for public consultation.

“It is also possible for the manufacturers to provide further comment on the committee’s interpretation of their products’ clinical effectiveness or consider reducing the price they are asking the NHS to pay through a patient access scheme,” Dillon said.

NICE has not recommended Faslodex (fulvestrant) for women with locally advanced or metastatic breast cancer after its Appraisal Committee declared it was not a good use of NHS resources.

The Committee raised questions over the data supplied by AstraZeneca on the treatment’s efficacy and its cost effectiveness.

Sir Andrew Dillon says the Committee “had not been given any conclusive evidence” that Faslodex extends life or delays tumour progression when compared with current treatment options.

Faslodex was being appraised as an alternative to aromatase inhibitor therapy in postmenopausal women who have locally advanced or metastatic breast cancer, that is oestrogen-receptor-positive.

It is licensed for postmenopausal women with oestrogen receptor positive, locally advanced or metastatic breast cancer for disease relapse on or after adjuvant anti-oestrogen therapy, or disease progression on therapy with an anti-oestrogen.

In line with its European marketing application, the decision by NICE’s independent panel of experts relates to the use of the inhibitor once anti-oestrogen treatments are no longer controlling the spread of the tumour.

But during the appraisal it was not able to consider the clinical and cost effectiveness of the treatment when used outside of its marketing authorisation.

“After analysing the evidence comparing fulvestrant’s clinical effectiveness with aromatase inhibitor therapy, our independent committee found that the estimates of overall survival and time to tumour progression were very uncertain,” said Sir Andrew Dillon.

“While it is important for women with locally advanced or metastatic breast cancer to have a range of options, NICE has to ensure that the NHS provides treatments that bring benefits which are value for money.”

NICE’s decision is now open to public decision. The Institute expects to publish final guidance in January 2012.

Takeda’s Mepact has won approval from the SMC for the treatment of high grade non-metastatic osteosarcoma in children, adolescents and young adults aged between 2 and 30.

Following a resubmission Mepact will now be available to all eligible patients on NHS Scotland after it was shown to reduce the risk of death by almost a third.

Yasuhiro Fukutomi, Managing Director of Takeda UK, says the company has “always been committed” to achieving a “successful conclusion for osteosarcoma patients in Scotland”.

Osteosarcoma is a rare and often fatal form of bone cancer with approximately 150 new cases in the UK each year.

There have been no medical advances in the treatment of the condition in the last two decades. Current treatment is chemotherapy given before and after the tumour has been surgically removed (resection).

But for up to a third of newly diagnosed patients the cancer will return after surgery and standard chemotherapy, and between a third and half of all children and young adults will not survive beyond five years of being diagnosed.

Roger Paul, Chairman of the Bone Cancer Research Trust, welcomed the SMC’s decision.

“This is a fantastic result which means that children and young adults in Scotland have access to this treatment that has been shown to improve long-term survival in a large clinical trial,” he said.” There is strong support for Mepact from clinicians, patient groups, patients and their families alike, and the SMC’s recognition of the potential clinical benefits of Mepact is welcomed.”