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Roche's Tecentriq Gets FDA Approval for First-Line NSCLC

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Roche (RHHBY - Free Report) announced that the FDA has approved a label expansion of its immuno-oncology drug, Tecentriq.

The drug has been approved in combination with Avastin (bevacizumab), paclitaxel and carboplatin (chemotherapy) for the first-line treatment of patients suffering from metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumour aberrations.

The approval was based on positive results from the phase III IMpower150 study, which showed that Tecentriq combined with Avastin and chemotherapy helped patients live significantly longer compared to Avastin and chemotherapy.

Meanwhile, Roche is working with the FDA on post-marketing commitments (PMCs) to determine the potential effects of Tecentriq-related anti-drug antibodies (ADAs) and neutralising antibodies (NAbs) across all studies.

We remind investors that Tecentriq is already approved in the Unites States for the treatment of patients suffering from metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumour has EGFR or ALK genetic alterations.

The drug is also approved for the treatment of patients with previously-treated metastatic NSCLC and also for those with advanced or metastatic urothelial cancer (mUC) who are not eligible for cisplatin chemotherapy, or have had disease progression during or following platinum-containing therapy.

Shares of Roche have gained 2.9% so far this year compared with the industry’s growth of 10.3%.


Roche is working to expand the drug’s label further. The company currently has nine phase III studies evaluating Tecentriq alone or in combination with other drugs.

Tecentriq sales came in at CHF 524 million in the first nine months of 2018, up 49%. A label expansion of the drug in the NSCLC market will further boost sales, given the potential of the same.

However, competition is stiff in the first-line NSCLC market. Merck’s (MRK - Free Report) Keytruda is already approved for the first-line treatment of NSCLC.

Bristol-Myers Squibb Company’s (BMY - Free Report) Opdivo is also in the race for the first-line NSCLC treatment. However, the FDA extended the review period of the company’s application by three months and set a target action date of May 20, 2019.

Zacks Rank & Other Stock to Consider

Roche currently carries a Zacks Rank #2 (Buy). Another well-positioned stock in the healthcare sector is Gilead Sciences, Inc. (GILD - Free Report) , which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Gilead’s earnings per share estimates increased from $6.64 to $6.93 for 2018 over the past 60 days. Estimates for 2019 are also up by 30 cents.

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