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Roche's Lung Cancer Candidate Gets Priority Review in U.S.

Roche Holdings RHHBY announced that the FDA has accepted the Biologics License Application (BLA) and granted Priority Review for its immunotherapy candidate, atezolizumab, for the treatment of patients suffering from locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease expresses the protein PD-L1 (programmed death ligand-1), as determined by an FDA-approved test, and who have progressed on or after platinum-containing chemotherapy.

We remind investors that the candidate was granted Breakthrough Therapy Designation by the FDA in Feb 2015 for the treatment of patients with NSCLC.

As per the American Cancer Society, more than 224,000 people will be diagnosed with lung cancer in 2016 in the U.S., with NSCLC accounting for 85% of all cases of lung cancers.

A decision by the FDA is expected by Oct 19, 2016. On the other hand, a premarket application (PMA) is also under review by the FDA for a companion immunohistochemistry (IHC) test developed by Roche Tissue Diagnostics.

Last month, the FDA accepted the company’s BLA and granted Priority Review for atezolizumab for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC). The candidate is also being evaluated for other cancers.

Roche, a leader in oncology drugs, is currently facing challenging conditions due to the adverse impact of currency volatility, and generic competition for Xeloda and Valcyte on the company’s business.

Hence, we expect investor focus on new drug approvals as well as the label expansion of existing drugs, which should mitigate the impact of these headwinds, going ahead.

Roche currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Novo Nordisk A/S NVO, Eli Lilly and Company LLY, and Johnson & Johnson JNJ. All the three stocks carry a Zacks Rank #2 (Buy).

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ROCHE HLDG LTD (RHHBY): Free Stock Analysis Report
 
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NOVO-NORDISK AS (NVO): Free Stock Analysis Report
 
JOHNSON & JOHNS (JNJ): Free Stock Analysis Report
 
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