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Roche gets EU okay for Avastin/Tarceva combination

Lung cancer therapy ‘significantly’ extends progression-free survival
Roche

Roche has been granted approval in Europe for Avastin in combination with Tarceva for patients with EGFR-positive non-small cell lung cancer (NSCLC).

This is the first approval worldwide for Avastin (bevacizumab) in combination with another targeted cancer therapy, according to Roche.

Avastin targets VEGF while Tarceva is an EGFR inhibitor - pathways known to be drivers of tumour growth - and both are already approved individually as NSCLC therapies.

The approval is based on the results of a pivotal phase II trial, which showed that giving Avastin alongside Tarceva as a first-line therapy in this patient population reduced the risk of disease progression or death by 46% compared to Tarceva alone.

Patients given the combination lived without disease progression for a median of 16 months, more than six months longer than those taking Tarceva alone. Most people with lung cancer who are diagnosed with advanced-stage disease typically die within 12 months of diagnosis.

"The combination of Avastin and Tarceva represents a new standard of care for patients with this type of lung cancer," said Roche's chief medical officer Sandra Horning.

The approval provides the 23,000 people diagnosed with EGFR-positive advanced NSCLC every year with "a powerful combination therapy that can significantly extend progression-free survival beyond one year, representing important progress for a group of patients who typically face a poor prognosis".

The approval is something of a turnaround for the combination, which was previously abandoned as a treatment for kidney cancer.

An earlier phase III (BeTa) trial in advanced NSCLC failed to show an improvement in overall survival when Avastin was added to second-line Tarceva, but showed a promising progression-free survival benefit versus Tarceva alone.

Similarly, the ATLAS trial of the combination as a maintenance therapy owed a benefit on PFS but not overall survival. However, both of these trials enrolled the general advanced NSCLC population rather than patients with EGFR-positive tumours.

Avastin is already Roche's biggest-selling drug with sales of around $7bn last year, although it could face competition from biosimilars from 2019 in the US and 2022 in Europe, unless patent protection is overturned in the courts.

Tarceva has seen sales slide a little of late thanks to increased competition in the EGFR inhibitor class - with 2015 sales down 7% to around $1.2bn - so the new approval could help buoy the product.

Article by
Phil Taylor

9th June 2016

From: Regulatory

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