NICE draft guidance does not recommend Afinitor (everolimus), a treatment for advanced breast cancer that can increase progression-free survival by four months.

The Novartis drug, described by charity Breakthrough Breast Cancer as “one of the biggest advances in breast cancer treatment in many years”, does not meet NICE’s criteria for an ‘end of life treatment’.

The decision will heighten concern over NICE’s QALY metric for value, which the European Commission recently declared to be scientifically invalid.

Afinitor, an oral formulation of everolimus (which is already widely used as an immunosuppressant), is licensed for use in post-menopausal women with advanced HER-2 negative breast cancer, which will not respond to Herceptin.

The drug inhibits the division of tumour cells and the growth of blood vessels around a tumour, thereby inhibiting tumour growth and metastasis.

Clinical trial results published in September 2012 found that Afinitor could ‘stall’ advanced breast cancer by four to five months.

Dr Rachel Greig of Breakthrough Breast Cancer said: “Everolimus is one of the biggest advances in breast cancer treatment in many years.”

Though “by no means a cure,” she commented, “it could give patients several extra months of good quality of life with their families.”

Sir Andrew Dillon, NICE’s Chief Executive, explained: “While the independent Appraisal Committee acknowledged that everolimus may offer a step change in treatment by restoring sensitivity of the tumour to hormone therapy, the evidence highlighted uncertainty relating to how much the treatment extends overall survival.”

The failure to extend overall survival was only considered crucial because Afinitor did not meet NICE’s criteria for an ‘end of life drug’, since its target patients had a life expectancy slightly over two years.

Consultation on the draft guidance will remain open until 22 April 2013.

A new Tumour Profiling Unit at the Institute of Cancer Research (ICR) in London will spearhead research into ‘personalised’ medicine and drug resistance in cancers.

The new research centre, the largest of its kind in the NHS, will analyse tumour cell DNA to pinpoint the critical mutations that cause cancer.

The aim is to develop many ‘personalised’ drugs, such as Herceptin, that can attack cancers with a specific genetic characteristic.

Tumour samples from patients at the Royal Marsden Hospital will be repeatedly tested to identify the genetic mechanisms underlying tumour development and drug resistance.

The Tumour Profiling Unit will also store the genetic codes of cancer patients, and make the findings available to doctors and pharmaceutical companies.

Professor Alan Ashworth, the ICR’s Director, said: “None of this is science fiction. This is now happening. We think we’re pioneering the clinical application of this by setting up the Tumour Profiling Unit, but one would think this would be absolutely routine practice for every cancer patient – and that’s what we’re aiming to bring about.”

Professor Ashworth compared cancer treatment to the game ‘Whack-a-Mole’: every time a cancer drug is successful, tumours develop resistance to it. The new research unit aims to find treatments that can stop the cancer evolving.

According to a recent DH announcement, the entire genetic code of up to 100,000 NHS patients with cancer and rare diseases will shortly be sequenced to facilitate research.

Pharma giant Roche has gained an EU approval for one of its breast cancer drugs and lost a US approval for another.

The EMA has recommended Herceptin (trastuzumab) for a licence extension that would see the drug used earlier in the progression of breast cancer.

In the same week, the FDA has revoked its approval for Roche’s Avastin (bevacizumab) as a treatment for breast cancer on the grounds that its benefits are outweighed by its side-effects.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has backed the use of Herceptin to treat patients with HER2-positive early breast cancer.

The drug is indicated for use in combination with neoadjuvant chemotherapy, followed by adjuvant Herceptin therapy.

The CHMP recommends the drug for use where the cancer is locally advanced or where tumours are larger than 2cm in diameter.

Herceptin is already approved in the EU for metastatic HER2-positive breast cancer. The drug works by reducing the body’s production of HER2, a growth factor that increases the aggressiveness of breast tumours.

The FDA has revoked its former approval for Roche’s breast cancer drug Avastin on the grounds that its benefits are modest and do not outweigh its side-effects. This follows the FDA’s decision in July to revoke Avastin’s approval in metastatic breast cancer.

The risks of Avastin include severe hypertension, bleeding, heart attack, heart failure and membrane perforations, the FDA said.

FDA Commissioner Margaret Hamburg commented: “After reviewing the available studies it is clear that women who take Avastin for metastatic breast cancer risk potentially life-threatening side effects without proof that the use of Avastin will provide a benefit.”

Roche plans further studies to identify subgroups of advanced breast cancer patients who may benefit from treatment with Avastin, particularly in combination with paclitaxel.

Avastin will remain on the US market for other indications, including colon, lung, kidney and brain cancers.

The drug is currently approved in Europe for use in combination with paclitaxel to treat breast cancer.

The FDA has again extended the indication for Erbitux (cetuximab) and approved the treatment for patients with advanced head and neck cancers in combination with chemotherapy.

The extension is based on the EXTREME study of 442 patients previously untreated with chemotherapy that demonstrated those treated with Erbitux lived 10.1 months on average, compared with 7.4 months on those treated with chemotherapy alone.

Richard Pazdur, Head of Oncology, FDA, says the medication is an “important tool” for doctors and patients.

Erbitux is now approved for five separate indications across two tumour types and becomes the first regimen in 30 years with extended overall survival in patients with recurrent locoregional or metastatic squamous cell carcinoma of the head and neck to be approved.

Medtronic has launched its T2 Altitude expandable corpectomy device for spinal stabilisation and correction worldwide.

The expandable vertebral body replacement cage features a self-locking mechanism that removes the need for placing a set screw during surgery, using bone graft to create contact to encourage fusion with the device.

Doug King, Senior Vice President and President of Medtronic Spinal, said that the new product demonstrates the company’s “long-term commitment to therapies for complex spine disorders for spinal tumour, trauma and deformity patients”.

Cancer patients can also benefit from the product. If the cancer has spread to the spine, the surgeon may replace the affected vertebrae with the T2 Altitude device.

More than 150,000 spinal fractures occur in North America every year, of which approximately 11,000 are spinal cord injuries.

Based in Memphis, Medtronic Spinal provides advanced treatment through the collaboration with surgeons and researchers to offer affordable, minimally-invasive products and medical technologies for neurological, orthopaedic and spinal conditions.

The FDA has approved Abbott Molecular’s Vysis ALK Break Apart FISH Probe companion diagnostic for lung cancer patients.

The test detects all ALK gene rearrangements and is the only FDA-approved diagnostic assay to predict response using Pfizer’s targeted therapy Xalkori for patients with advanced ALK-positive non-small cell lung cancer (NSCLC).

Dr Mark Brecher, Chief Medical Officer of LabCorp, said that the personalised medication “will play an even larger role in cancer care, assisting physicians in administering the treatments best suited to the disease.”

The Probe Kit for Xalkori uses Fluorescence In-Situ Hybridisation (FISH) to detect a specific rearrangement in the ALK gene.

Approximately 3-5% of NSCLC tumours are characterised by genetic rearrangements in the ALK gene. When this gene is altered by combining ALK with other gene sequences, the pathway becomes constitutively active causing mutation. Xalkori inhibits the mutant ALK protein, and halts the growth of cancer cells.

LabCorp’s Centre for Molecular Biology and Pathology (CMBP) supported clinical studies of the new diagnostic and collaborated with Abbott Molecular in the analytical validation of the product.

According to LabCorp, approximately 6,500-11,000 people will develop advanced ALK-positive NSCLC in the US in 2011.

The Vysis ALK Break Apart FISH Probe test is available for patient testing through LabCorp, which is one of the largest medical diagnostic companies in the US.

A new ultrasound scanning technology that enables accurate tissue characterisation, improving the management of cancer, has won the 2011 Frost & Sullivan Europe Technology Innovation Award.

Belgian company Advanced Medical Diagnostics (AMD) has won the award for its development and commercialisation of the HistoScanning technology, used in treatment of prostate cancer.

Frost & Sullivan Research Analyst Darshana De said: “Prostate HistoScanning is an innovative ultrasound-based application that utilises advanced tissue characterisation algorithms to visualise the position and extent of tissue suspected of being malignant in the prostate gland.”

He added that “its design is quite unique and superior to other ultrasound-based technologies.”

The technology offers comparable efficacy to MRI in cancer detection while having greater ease of access and use. Clinical studies have shown that it can detect significant cancer lesions with 93% sensitivity.

De noted: “Prostate HistoScanning offers the simplicity of ultrasound and results that are comparable to MRI in a format that can be made available to all patients in the physician’s office.”

More than 7,000 patients in the EU have undergone Prostate HistoScanning, which has been shown to reduce the number of prostate biopsies by 30% through its ability to make biopsy procedures more selective.

“This technology is serving an unmet need in the management of cancer patients and therefore has the potential to significantly change the current clinical pathway and reduce overall costs,” De commented.

Applications of HistoScanning could be extended to detection of breast cancer and other solid tumours.

The Frost & Sullivan Best Practices Awards recognise companies that have shown outstanding achievement and performance. The Technology Innovation Award is based on assessment of the uniqueness of a new technology, its relevance to industry and its impact on new products, functionality and customer value.

Novartis has received approval from the European Commission for the use of Afinitor (everolimus) tablets to treat patients with advanced pancreatic neuroendocrine tumours (NET).

The decision was based on Phase III data which indicated the tablets more than doubled the time without tumour growth.

Hervé Hoppenot, President, Novartis Oncology, says the approval means thousands of patients “will have a new targeted approach” for the aggressive cancer.

The decision applies in all 27 European Union states, plus Iceland and Norway. Novartis are also currently seeking additional regulatory submissions across the rest of the world.

The RADIANT-3 Phase III trial was the largest clinical trial to date in advanced pancreatic NET. Results found that Afinitor reduced the risk of cancer progression by 65% when compared with placebo in patients with advanced stages of the disease.

An improvement in progression-free survival was also found in all patient subgroups, including those who had not received prior chemotherapy.

Afinitor is currently approved in the EU for the treatments of patients with advanced renal cell carcinoma (RCC) whose disease has progressed on or after treatment with vascular endothelial growth factor (VEGF)-targeted therapy.

It is also approved in Europe for the non-oncology patient population under the trade name Certican for the prevention of organ rejection in heart and kidney transplant recipients.

A new imaging technique enables scientists to trace individual cancer cells as the growth of a tumour spreads through the brain.

Researchers at the Case Western Reserve University School of Medicine used cryo-imaging to look at a mouse model of glioblastoma multiforme, an aggressive cancer with no treatments to stop it spreading.

Susann M. Brady-Kalnay, Professor of Molecular Biology and Microbiology at the Case Western Reserve School of Medicine said: “We're able to see things we couldn't before, and we can use these images to understand how tumour cells invade and disperse”.

The cryoimaging system consisted of a fluorescence microscope, robotic imaging positioner, customized cryostat, PC-based control system, and visualization/analysis software. The technique alternates between sectioning and imaging, collecting colour brightfield and fluorescent blockface image volumes.

The scientists used a model that included four different cell lines of brain cancers at various stages of tumor development and dispersion. The cancer cells were modified with fluorescent markers and implanted in the model's brain.

Researchers found that two cell lines, a human brain cancer LN229, and a rodent cancer CNS-1, best resembled the actions of glioblastoma multiforme in human patients.

The ability to produce clear and detailed images will be invaluable when evaluating the potency of drugs and other therapies designed to block dispersal of glioblastoma multiforme cells.

A new study has found that radioembolisation improves survival chances of patients suffering from hepatocellular carcinoma (HCC).

Hepatology reported that patients with tumours at different stages, including those with advanced liver cancer who had limited access to treatment options, are likely to benefit most from the procedure.

Dr Bruno Sangro from the Clinica Universitaria de Navarra in Pamplona, Spain said: “Our findings show strong evidence of the survival benefit with radioembolisation, even in patients with advanced disease who have few treatments options.”

Radioembolisation consists of a large dose of radiation directly delivered to the tumour via a small tube inserted in the groin.  Tumours routinely become resistant to chemotherapy but not to these lethal doses of radiation.

An advantage of the therapy is that all the pretreatment and therapy is done on an outpatient basis so that only a limited amount of time will be spent by the patient in hospital.

The study assessed 325 HCC patients at eight European centres. Results revealed an average overall survival rate of almost 13 months with radioembolisation.

Almost 700,000 people died of HCC in 2008, with more than 80% of cases caused by hepatitis B and C infections, according to the World Health Organisation (WHO).

The National Cancer Institute estimates there will be 26,000 new cases of liver and bile duct cancer in the US by the end of 2011, resulting in 20,000 deaths.