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Roche Gets Lung Cancer Drug Alecensa Approval in Swiss Market

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Overview

On April 3, 2018, Roche Holding (RHHBY) announced that its drug Alecensa has been approved in Switzerland as a first-line treatment for advanced or metastatic ALK (anaplastic lymphoma kinase)-positive NSCLC (non-small cell lung cancer). The drug was previously approved in Switzerland for treating patients with advanced or metastatic ALK-positive NSCLC that worsened after treatment with Pfizer’s (PFE) anti-cancer drug crizotinib and who could not tolerate crizotinib treatment.

Alecensa was approved as a first-line treatment for advanced or metastatic ALK-positive NSCLC in Europe in December 2017 and in the United States in November 2017. The drug has also received approval for use as a first-line treatment for ALK-positive NSCLC treatment in Japan and Turkey.

Earlier in 2017, Novartis (NVS) received approval for Zykadia (ceritinib) as a first-line treatment for ALK-positive NSCLC treatment.

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ALEX trial results supported approval

Alecensa’s approval in Switzerland was based on global Phase III trial results. The ALEX trial showed a significant reduction of 53% in patient deaths or worsening in condition after the treatment with Alecensa compared to the standard treatment. The risk of spreading the disease into the CNS (central nervous system) or brain when patients were treated with Alecensa were found to be reduced by 84%.

Alecensa is one of Roche’s key products and is currently approved in 50 countries. It drives the company’s growth. It is expected to continue to be a significant growth driver since it has received a number of expanded indications recently and is expected to capture additional market share in the oncology space going forward. In fiscal 2017, Alecensa generated sales of 362 million Swiss francs. The drug was launched in 2016 and has shown significant growth in the United States. In Japan, Alecensa sales have seen continued growth momentum.

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