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.

A vibrating gel injected into the vocal tissues of the throat could restore vocal capacity to people whose voices have been damaged by surgery.

The new gel (pictured), developed by Harvard Medical School surgeon Steven Zeitels in partnership with MIT bioscientist Bob Langer, can vibrate up to 200 times per second, mimicking the action of human vocal cords.

Their research has been partly funded by singers Roger Daltrey (of The Who) and Steven Tyler (of Aerosmith), both of whom have suffered loss of singling ability following surgery, thought its main funding source is the Institute of Laryngology and Voice Restoration.

It has recently been reported that Dr Zeitels is helping to treat singer Adele, who has had to cancel her 2011 tour to undergo surgery to alleviate issues with her throat.

Injected directly into the vocal cords, the gel responds to breath and muscle tension by vibrating.

Zeitels is a professor of laryngeal surgery whose patients include singer Julie Andrews as well as Daltrey and Tyler. He was directed to Langer by a number of scientific experts.

Langer is famous for his work on anti-cancer drugs that starve tumours of their blood supply, including Roche’s Avastin, and on time-release drug delivery technologies for chemotherapy.

Creating artificial vocal cords requires a durable material that can bond with the existing tissue and respond correctly to muscle contractions and air movement. Langer has developed a polyethylene glycol gel tailored at the molecular level.

“With synthetic materials, the beauty is you can tailor them and build in the degradation rate or mechanical strength you need because you’re making them from scratch,” Langer commented.

Zeitels and Langer plan to test the gel in a cancer patient for the first time in 2012.

The EC has approved Eli Lilly’s Alimta (pemetrexed for injection) as continuation maintenance therapy in patients with nonsquamous non-small cell lung cancer (NSCLC).

Alimta is the first chemotherapy to be approved in Europe for continuation maintenance therapy, for NSCLC patients who have shown a positive response or disease stabilisation following treatment with first-line Alimta plus cisplatin.

Allen Melemed, Senior Medical Director at Lilly Oncology, said: “Tailored therapies have come to the forefront of cancer treatment because they allow clinicians to select the right treatment for the right patient.”

The European approval was based on results from PARAMOUNT, a randomised double-blind Phase III study of 939 patients with advanced nonsquamous NSCLC.

The study showed that Alimta continuation maintenance therapy improved progression-free survival, as well as overall survival, after Alimta-cisplatin first-line therapy.

Alimta is approved in Europe and the US for three indications in patients with advanced nonsquamous NSCLC, including first-line treatment in combination with cisplatin, second-line treatment, and maintenance treatment of patients whose disease has not progressed immediately following platinum-based chemotherapy.

The drug is also approved for the treatment of chemotherapy-naïve patients with unresectable malignant pleural mesothelioma in the EU and US.

Lung cancer is the most common form of cancer in the world, causing 1.3 million cancer deaths every year. Approximately 85-90% of all lung cancers are NSCLC.

Alimta was recommended by CHMP as continuation maintenance therapy for patients with advanced nonsquamous NSCLC in September 2011 and by NICE for use by the NHS in September 2009.

The first advance in the treatment of bone cancer in children and young people in two decades has been recommended in final guidance by NICE.

Takeda’s Mepact (mifamurtide), in combination with postoperative multi-agent chemotherapy, has been made available to the NHS at a reduced cost under an agreed Patient Access Scheme (PAS).

Sir Andrew Dillon, NICE Chief Executive, says for those treated with Mepact “the health benefits continue over the rest of their lives, effectively being a cure”.

The appraisal saw NICE for only the second time in its history clarify its ‘methods guide’ for treatments which can restore health over a long period, and together with the PAS, reduced the cost per QALY of Mepact.

“Following a clarification from the NICE Board on this issue, and in addition to a revised patient access scheme from the manufacturer, the extra cost per unit of health gained that the NHS will pay for mifamurtide is now lower than previously determined, but still above the normal range that is usually accepted,” said Sir Andrew.

“After having looked again very carefully at a number of factors (such the curative potential of the drug for some people and the small patient population) and taking these factors into account, the Committee was able to recommend mifamurtide for osteosarcoma as a cost-effective use of NHS resources.

“Today’s recommendation of mifamurtide will help children and young people with this very painful and distressing disease, as well as providing some for hope for them, and the people caring for them.”

NICE initially failed to recommend the treatment in an FAD published in October last year. However, after the revision to its methods guide and the proposed PAS, Yasuhiro Fukutomi, Managing Director of Takeda UK, says the company is delighted with the outcome.

“We are grateful to all those who have been involved in this long process including those at NICE, the Department of Health, physicians and patient organisations,” he said. “It has taken everyone’s collaboration to lead us to this successful conclusion for osteosarcoma patients today.”

Mepact was recommended by NICE in draft guidance in September and was approved for use in Scotland in August 2011.

The FDA has approved Abbott Molecular’s genetic diagnostic, Vysis EGR1 FISH Probe Kit, to detect acute myeloid leukaemia (AML).

The new in vitro test is the third of Abbott’s FISH assays to be cleared for oncology applications in the US in the past two months.

Stafford O'Kelly, Head of Abbott's Molecular Diagnostics Business said that the medical technology “can identify which AML patients have the chromosomal abnormality upon diagnosis and provides physicians with another clinically validated tool to assess a patient's overall prognosis”.

The Kit’s technology detects chromosomal deletion in the bone marrow, and can be used in addition to cytogenetics, other biomarkers, morphology and other clinical information, at the time of AML diagnosis to determine prognosis.

Each year, more than 12,000 people are diagnosed with AML, which is a rapidly progressive disease. Current standard procedure involves aggressive chemotherapy drugs, while some patients may require a stem-cell transplant to replace unhealthy bone marrow with leukaemia-free stem cells.  

Part of Abbott, Abbott Molecular is a leader in molecular diagnostics, analysing DNA and RNA at the molecular level. Abbott Molecular's tests aim for earlier detection or diagnosis, to provide information of appropriate treatment, and improve monitoring of disease progression.

Abbott is a global healthcare company, which discovers, develops, manufactures and markets pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs nearly 90,000 people and commercialises its products in more than 130 countries worldwide.

Roche’s Tarceva (erlotinib) has been granted a European licence as a first-line monotherapy for patients with an advanced form of non-small cell lung cancer (NSCLC) with a certain mutation.

The licence is based on Phase III trials which showed Tarceva nearly doubled the time patients lived without their disease progressing compared with chemotherapy.

Dr Liz Toy, Royal Devon and Exeter Foundation NHS Trust, says the new indication is “exciting news” for patients who may have an “enhanced response” using the treatment.

Tarceva is already approved for use in the UK for patients with advanced or metastatic NSCLC, irrespective of a patient’s epidermal growth factor receptor (EGFR) status.

Data from the two Phase III studies, EURTAC and OPTIMAL, investigated patients with an EGFR mutation and demonstrated that Tarceva significantly increased the time patients live without the cancer progressing.

“The European approval for Tarceva is good news for patients with a genetically distinct form of lung cancer because these patients may derive greater benefit when the medicine is used as an initial treatment,” said Hal Barron, Chief Medical Officer and Head, Global Product Development at Roche.

More than 39,000 new cases of lung cancer are diagnosed in Britain each year.