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Roche's sBLA for Tecentriq-Abraxane Combo Accepted by FDA

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Swiss oncology major Roche (RHHBY - Free Report) announced that the FDA has accepted its supplemental Biologics License Application (sBLA) for immuno-oncology drug, Tecentriq.

The sBLA seeks to get FDA approval for Tecentriq in combination with Celgene Corporation’s (CELG - Free Report) Abraxane and carboplatin for the initial (first-line) treatment of patients suffering from metastatic non-squamous non-small cell lung cancer (NSCLC) who do not have EGFR or ALK genomic tumour aberrations.

A decision from the FDA is expected by Sep 2, 2019.

The sBLA is based on positive results from the phase III IMpower130 study, which met its co-primary endpoints of overall survival (OS) and progression-free survival (PFS) in the first-line treatment of metastatic non-squamous NSCLC.

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.  In December 2018, the FDA also approved Tecentriq in combination with Avastin, paclitaxel and carboplatin (chemotherapy) for the first-line treatment of people with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations.

The drug is also approved for certain types of untreated or previously treated metastatic urothelial carcinoma (mUC).

Shares of Roche have gained 10.9% in the past six months, outperforming the industry’s growth of 4.5%.


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 for lung cancer.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 first-line NSCLC market will further boost sales, given the potential of the market.

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

Roche currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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