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.

Bristol-Myers Squibb and Gilead Sciences have signed a licensing agreement to develop and commercialise a potential fixed-dose combination single pill for the treatment of HIV.

The combination would include BMS’ protease inhibitor Reyataz (atazanavir sulfate) and Gilead’s pharmacoenhancing agent cobicistat.

Elliott Sigal, Executive Vice President, Chief Scientific Officer and President, R&D, BMS, says the pill has the potential “simplify HIV therapy” and address unmet needs for innovative treatment options.

The combination is currently being studied in Phase II and Phase III studies in HIV-1 treatment-naive patients.

Reyataz is a prescription medicine used in combination with other medicines to treat people aged 6 years of age and older who are infected with HIV. Gilead’s cobicistat is a boosting agent that increases blood levels of certain strains of the virus.

Under the terms of the agreement, BMS will be responsible for the worldwide formulation, manufacturing, development, registration, distribution, and commercialisation. It will pay Gilead an undisclosed royalty based on the annual net sales of the product when released.

“This collaboration with Gilead builds on Bristol-Myers Squibb’s longstanding commitment to develop medicines that have the potential to provide meaningful benefit to HIV patients, specifically aiming to enhance treatment options,” said Mr Sigal.

Gilead will retain the sole rights for the manufacturing, development and commercialisation of cobicistat as a stand-alone product and for any future combinations with other agents.

Pfizer is suing Merck to try to block its new Lipitor-plus-Zetia combination drug.

The new pill will be similar to Merck’s Vytorin, combining the company’s own statin drug Zocor (simvastatin) with cholesterol medication Zetia.

Analysts expect a Lipitor/Zetia version to generate $500 million by 2015.

Pfizer has faced generic competition from various angles on its blockbuster cholesterol therapy. The company recently reached a settlement agreement with a number of pharmaceutical companies to delay the launch of generic versions of Lipitor (atorvastatin) in the UK until May 2012.

It has also allowed Ranbaxy Laboratories to sell its generic version of the drug on November 30^th as well as agreeing to supply an authorised generic to Watson Laboratories on the same day.

However, Pfizer still has some patents on Lipitor that aren’t due to expire for a few years, and is citing one of these in its case against Merck.

The company has stated the patent covering Lipitor's crystalline structure, which is due to expire in 2017, but Merck claims that its Lipitor-plus-Zetia pill won't infringe on the patent.

The lawsuit triggers a 30-month regulatory delay, during which time efficacy questions about Vytorin will be asked. A previous study has found no significant difference in arterial narrowing with Vytorin than with Zocor use alone.

A new study is due in 2013, and if the clinical data works against Vytorin, then a Lipitor/Zetia combo may not be as successful in the market as expected.

The CHMP has adopted a positive opinion for Novartis’ Rasitrio, recommended as replacement therapy for patients with high blood pressure.

The single-pill treatment combines calcium channel blocker amlodipine with the diuretic hydrochlorothiazide (HCT) and Rasilez, the only approved direct renin inhibitor in the world.

Professor Roland E. Schmieder at the University Hospital of the University Erlangen-Nuremberg, Germany, commented that the drug will provide patients with a “comprehensive and convenient high blood pressure treatment in one pill”.

The CHMP positive opinion of Rasitrio is based on a Phase III clinical trial involving more than 1,181 patients with high blood pressure. Data showed that Rasitrio significantly reduced blood pressure compared to dual combinations of each of its individual components.

David Epstein, Division Head of Novartis Pharmaceuticals, said: “This positive CHMP opinion is an important step towards approval and making this new triple combination therapy available for patients whose blood pressure is not under control and who may require multiple medications.”

Approximately 1 billion people have high blood pressure worldwide, with many remaining uncontrolled despite treatment, with up to 85% of patients requiring multiple medications to help control their blood pressure.

High blood pressure can cause damage to the heart, brain and kidneys and is also linked with other conditions such as diabetes.

NICE has recommended Roche’s MabThera (rituximab) in draft guidance for advanced follicular lymphoma after reviewing a previous technology appraisal.

MabThera was previously recommended in combination with CVP chemotherapy and has now been recommended with CHOP, MCP and CHVP regimens.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, says that “four good quality” trails indicated the additional treatment options “help patients live longer and improve their overall response”.

More than 1800 people in England and Wales have follicular lymphoma. Currently, advanced follicular lymphoma is not curable, and so the aim of disease management is to both increase life expectancy and patients’ quality of life.

The original technology appraisal 110 was issues in September 2006. The guidance recommended the use of MabThera plus CVP as an option for first-line induction therapy for symptomatic stage III-IV follicular lymphoma.

Two years later, MabThera’s marketing authorisation was revised to allow the use of a wider range of chemotherapy regimens. As a result NICE’s Independent Appraisal Committee review the original appraisal and found the treatment to be both clinically and cost-effective as a first-line treatment when used with additional chemotherapy options.

“Committee members heard evidence that patients require different treatment combinations depending on their age and overall health,” said Professor Longson. “Some people are not fit enough to receive rituximab plus CVP, the most common form of treatment, and so other treatment options might be useful for them.

“In addition, the economic analyses demonstrate that adding rituximab to the chemotherapy regimens is good value for money. The independent advisory committee concluded that the cost of rituximab in relation to how well it works in combination with CVP, CHOP, MCP and CHVP is an effective use of NHS resources.”

The draft recommendation is now open for consultation with final guidance expected in January 2012.