Roche’s Tarceva (erlotinib) has been recommended in final guidance as a first-line option for people with EGFR mutation-positive non-small-cell lung cancer (NSCLC).

NICE’s independent Appraisal Committee concluded the treatment was a clinical and cost effective use of NHS resources, when supplied under an agreed Patient Access Scheme.

Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE, said the Institute was “pleased to be able to recommend another treatment option for this stage of the disease.”

As part of the appraisal, the Committee discussed the results from the updated analysis comparing Tarceva with Iressa. On balance, the Committee concluded, the sums of money either spent or saved are small given the uncertainties associated with the data.

Therefore, when supplied under the Patient Access Scheme, Tarceva is recommended as an option with patients who have locally advanced or metastatic EGFR-TK mutation-positive NSCLC.

Roche’s Tarceva (erlotinib) has been recommended in final draft guidance as a first-line option for people with EGFR mutation-positive non-small-cell lung cancer (NSCLC).

The decision comes after Roche provided NICE with additional data on the clinical and cost effectiveness of Tarceva when supplied under an agreed Patient Access Scheme (PAS).

Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE, said the health regulator is “pleased to recommend another treatment” for NSCLC.

NICE recently recommended Iressa (gefitinib) as a first-line treatment for NSCLC. Roche were unable to provide any clinical data comparing Tarceva with Iressa, but specialists confirmed the two were similar and equally effective.

Tarceva and Iressa work differently to chemotherapy. The oral treatments are known as “target agents” due to the way they block certain processes in the cancer cells.

Data supplied by Roche showed Tarceva showed longer progression-free survival and similar overall survival compared with current treatment options. It expects that NICE’s recommendation will benefit approximately 11% of patients with NSCLC.

The PAS agreed between Roche and the DH may mean that Tarceva is supplied to the NHS free of charge in certain circumstances. Tarceva will be made available at a single cost of £12,200 per patient irrespective of the duration of treatment. However, Roche will only invoice the health service after the third monthly pack of Tarceva is supplied. Any patients who receive only one or two months of treatment will receive the drug without the NHS being charged.

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.”

NICE has requested further data on Tarceva (erlotinib) from Roche for the first-line treatment of locally advanced or metastatic EFGR mutation-positive non-small-cell lung cancer (NSCLC) in new draft guidance.

Roche failed to provide evidence on Tarceva’s clinical and cost effectiveness when compared to Iressa (gefitinib), NICE’s Appraisal Committee said.

Sir Andrew Dillon, NICE Chief Executive, said the data provided by Roche was not sufficient to compare Tarceva with a recommended option but hoped further information would be supplied.

The Committee has now asked Roche for an updated cost effectiveness analysis of Tarceva compared with Iressa with different progression-free survival and utility assumptions. Further sensitivity analyses on the cost of Tarceva changes depending on how many patients are able to continue taking the drug and Iressa after 60 days of treatment – the point at which the NHS currently has to start paying for Iressa under its agreed Patient Access Scheme – are also required.

“When it was asked to consider Tarceva, our independent advisory committee concluded that it did not have enough information to be able to make the decision to recommend or not recommend it for routine use in the NHS as an alternative to gefitinib,” said Sir Andrew. “It has therefore asked the manufacturer provide further analyses. We hope that Roche will be able to provide this additional information so that the Committee can consider it at its next meeting on the topic.”

The SMC recently approved the use of Tarceva as a first-line treatment for NSCLC. Lung cancer, after breast cancer, is the second most common cancer in England and Wales, with an estimated 40,800 newly diagnosed cases each year.

Roche saw Group sales fall 10% in Swiss francs (CHF) to 42.5 billion in 2011 due to the appreciation of the franc, and revenue decrease by 12% in its Pharmaceuticals Division after sales of Avastin and Tamiflu fell.

Pharmaceutical sales accounted for 32.7bn CHF after MabThera generated 6bn CHF (+8%), Herceptin 5.2bn CHF (+9%) and sales of Lucentis increased by 23% to 1.5bn CHF.

Severin Schwan, Roche CEO, says the Group achieved its “sales and earnings targets” in 2011 and made “significant progress with our pipeline”.

The company expects to record single-digit sales growth for the Group and its pharma division in 2012 after achieving several important regulatory milestones in Q4 of 2011.

Group sales in constant currencies were up 1% after its pharma division, excluding Tamiflu, grew at the same rate. Sales were up 2% in constant currencies in the US to 12.2bn Swiss francs and in international markets by 3% to 8.5bn. However, pharmaceutical sales in Western Europe dropped 3% to 8.2bn and in Japan by 6% to 3.8bn.

Core operating profit increased 6% in constant currencies, core earnings per share was up by 11% and net income jumped 26% to 9.5bn CHF in 2011.

Sales of cancer medicines Xeloda (1.3bn CHF; +8%), Tarceva (1.2bn CHF; +7%) and Zelboraf (31m) – recently launched in the US – were called “encouraging”. But a 7% decrease in sales of Avastin, NeoRecormon (-23%), Bonviva (-22%) and CellCept to (-14%) were put down to US health reforms, European austerity measures and Japanese biennial price cuts resulting in a negative growth impact of 295m CHF.

“With 17 positive late-stage clinical trials in 2011, we continue to build our future business with innovative products,” said Severin Schwan. “For 2012 we expect Group sales to grow at a low to mid-single-digit rate and we have set ourselves the target of high single-digit Core Earnings per Share growth.”

Roche has posted solid sales performance in the first nine months of 2011 with overall group activity up 2% to 31.5bn Swiss francs.

Sales in the pharmaceutical division grew 1% after growth of key medicines and markets, particularly in the international region where a 6% increase was recorded.

Severin Schwan, Roche CEO, says the Group is “on track to achieve our targets for 2011” after recording results in line with expectations.

The Group confirmed it is expecting low single digit growth this year and is still targeting Core EPS growth of approximately 10% despite a challenging environment and global health reforms.

US pharmaceutical sales were up 1% and driven mainly by demand for Lucentis, Rituxan and Actemra. But the company suffered an expected negative impact in sales of Avastin (pictured) after the uncertainty around the metastatic breast cancer indication in the US.

Sales were down 4% in West Europe, primarily due to government austerity measures, and 2% in Japan after the affects of the earthquake in the country in March, the company said. Although an increasing demand for products in China (+28%), Venezuela (+88%) and Brazil (+16%) helped boost figures internationally.

In the same period, Roche also reported positive data from seven clinical studies, a number of which have already formed the basis for regulatory filings and approval in Q3; including the launch of skin cancer medication Zelboraf and companion diagnostic cobas BRAF Mutation Test following FDA approvals in August and Tarceva (pictured) in the EU for EGFR-mutated non-small cell lung cancer.

“The successful US launch of our new melanoma medicine Zelboraf and the diagnostic cobas BRAF test has strengthened our leading position in personalised healthcare,” said Severin Schwan. “The good results we have achieved with new medicines in seven late-stage clinical trials so far this year further enhance our prospects for future growth.”

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.

Roche’s Tarceva (erlotinib) has received approval from the European Commission for use in patients with a type of non-small-cell lung cancer (NSCLC).

The European approval will enable its use as a first-line monotherapy in NSCLC patients with epidermal growth factor receptor (EGFR) activating mutations following impressive Phase III data.

Hal Barron, Chief Medical Officer and Head, Global Product Development, says the approval is “good news for patients”.

Tarceva is already approved in Europe for use in advanced or metastatic NSCLC, irrespective of a patient’s EGFR status, both as maintenance therapy after initial chemotherapy, and in patients whose disease has progressed following at least one course of chemotherapy.

Data from the European Randomised Trial of Tarceva vs. Chemotherapy (EURTAC) demonstrated that the treatment is superior to chemotherapy in EGFR activating mutation positive NSCLC.

The trial found that Tarceva nearly doubled median progression free survival and more than tripled the response rate compared to chemotherapy.

“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.

NICE has failed to recommend Tarceva (erlotinib) as a maintenance treatment for people with non-small-cell lung cancer – despite an appeal by Roche.

The agency’s independent Appraisal Committee felt there was too much “uncertainty” on the overall survival gain it provided patients and did not consider it value for money for the NHS.

Sir Andrew Dillon, NICE Chief Executive, says the Institute is “disappointed” not to recommend another maintenance treatment, but evidence supplied did not clarify how it compared against other recommended treatments.

Despite estimates by Roche that maintenance treatment with Tarceva can potentially extend life by approximately 3.3 months, NICE says the evidence was not sufficiently robust to demonstrate this extension to life.

Roche, who had already agreed a Patient Access Scheme with the DH, called for the draft guidance recommendation to be reversed at an appeal in May. However, NICE dismissed the review on all points.

Alimta (pemetrexed), which has been shown to offer a potential additional 5.2 months of life to patients with a specific type of lung cancer, was recommended for this indication under certain circumstances in June 2010.

Sales fell by 9% at Roche during the first-quarter of 2011 as a result of the weak Swiss franc and the decline of Tamiflu and Avastin.

In the first three months of 2011, Roche recorded sales of 11.12 billion francs (about $23.49 bilion) despite a 10% drop in its Pharmaceutical Division and a 4% fall in its Diagnostics Division.

But Severin Schwan, Roche CEO (pictured), says the company is “on track” to achieve its targets for the full-year.

Compared with the same time last year, first-quarter 2011 sales grew 2% in the US but fell 4% in Western Europe and 7% in Japan.

MabThera (rituximab) was the Basel-based company’s best seller during the quarter, earning 1.56 billion francs. Avastin (bevacizumab) also had sales of 1.42 billion francs, although this represented a fall of 6%. Sales of Herceptin (trastuzumab) (8%), Xeloda (capecitabine) (7%) and Tarceva (erlotinib) (8%) were also up.

Based on the sales, Roche has confirmed its full-year outlook with group and pharmaceutical sales – excluding Tamiflu – expected to grow at single-digit rates in local currencies, reflecting the impact of US healthcare reform and European austerity measures.