NICE draft guidance does not recommend Afinitor (everolimus), a treatment for advanced breast cancer that can increase progression-free survival by four months.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Consultation on the draft guidance will remain open until 22 April 2013.

Oral cancer drugs such as Glivec and Tarceva are negatively affected by other medications including steroids and antibiotics, according to a new US study.

The Medco Research Institute (MRI) has claimed that medications taken by as many as 75% of cancer patients interfere with the effects of oral kinase inhibitors, a major class of adjunctive cancer therapy.

The effect of the medication interference is to weaken the effectiveness of the anti-cancer treatment and/or increase its toxicity, the study found.

Oral kinase inhibitors, which suppress tumour cell metabolism, are widely prescribed for their ability to increase the effectiveness (and reduce effective dosage levels) of chemotherapy.

The MRI study, which looked at 4,617 cancer patients, found that 23–74% of them were being prescribed a medication that interfered with their oral cancer drug. Of these, 43% showed a reduction in the efficacy of the cancer drug and 68% showed an increase in its toxicity.

Oral kinase inhibitors include (UK trade names): Glivec (imatinib), Tarceva (erlotinib), Sprycel (dasatinib), Afinitor (everolimus), Tyverb (lapatinib), Tasigna (nilotinib), Votrient (pazopanib), Nexavar (sorafenib) and Sutent (sunitinib).

The medications that interfere with them, according to the study, are calcium channel blockers, antifungal agents, steroids, proton pump inhibitors and some antibiotics.

Dr Steve Bowlin, Senior Director at the MRI and co-author of the study, said: “Since these are drugs launched in the past decade for fairly small patient populations, we are learning more about how they are used in real-world settings as compared to traditional clinical trials that test safety and efficacy in a tightly-controlled environment.

“Oncologists are not always aware of other medications prescribed by other doctors and vice-versa, which can pose a real hazard for their patients on oral cancer therapies.”

The FDA has approved Abbott’s next-generation Xience Prime drug eluting stent to treat patients with complex coronary artery disease.

The Xience Prime Everolimus Eluting Coronary Stent System is based on the company’s cobalt-chromium stent technology and is designed to enhance deliverability, flexibility, and more accurate stent placement in patients with symptomatic heart disease due to de novo native coronary artery lesions.

The approval was based on results from the SPIRIT PRIME clinical trial, a prospective, multi-centre, open-label trial involving 500 patients with coronary artery disease at more than 60 centres in the US and Australia. Clinical results show that the trial met its primary endpoint of low rates of target lesion failure (TLF) at one year.

Dr Marco Costa, principal investigator of the SPIRIT PRIME trial, said: “Drug-eluting stent technology continues to advance, leading to improved outcomes for patients with coronary artery disease.”

He said that the medical device “will improve our ability to access challenging, complex lesions, and thereby improve care for our patients”.

Robert Hance, Senior Vice President at Abbott Vascular, said that the FDA’s approval “expands the range of treatment options that we can offer physicians for the benefit of their patients with coronary artery disease”.

Xience Prime received CE Mark Approval in 2009.

Abbott recently split into two companies, one concentrating on research-based pharmaceuticals and the other (Abbott) on medical products.

The European Commission has approved Novartis’ Votubia (everolimus) for patients aged three and over with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC), who not amenable to surgery.

The approval is based on a Phase II study that revealed 78% of patients experienced a reduction of 30% of more in the size of largest SEGA, and a third saw a reduction of 50% after six months.

Hervé Hoppenot, President, Novartis Oncology, says patients will have for the first time “an effective therapeutic option”.

TSC affects approximately one to two million people worldwide and is associated with a variety of resulting disorders. In Europe, the prevalence in general population is estimated to be nearly nine cases per 100,000.

Prior to Votubia being approved, the only treatment for patients in the European Union with SEGA associated TSC was brain surgery.

Dr Sergiusz Jozwiak, Professor, Department of Child Neurology, The Children's Memorial Health Institute, Warsaw, Poland, has welcomed its approval by the EC.

“This approval is an important step forward in managing SEGAs associated with tuberous sclerosis complex, as surgery was previously the only available treatment option in the EU for these patients,” he said. “As the first approved medication for this patient community, Votubia will help fill a critical unmet treatment need.”

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.