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Roche (RHHBY) Gets Approval for Label Expansion of Tecentriq

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Roche Holding AG (RHHBY - Free Report) announced that the European Commission (EC) has approved immunotherapy drug Tecentriq as a monotherapy for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after they have been previously treated with chemotherapy regardless of PD-L1 status.

The EC also granted marketing authorisation of the drug as a monotherapy for the treatment of people with locally advanced or metastatic urothelial carcinoma who have been previously treated with a platinum-containing chemotherapy or who are considered ineligible for cisplatin chemotherapy, regardless of PD-L1 status.

We note that the drug is already approved in the United States for these indications.

Approval in other geographies will further boost sales. Per estimates, 1.59 million patients die every year due to lung cancer.

Earlier in the month, the FDA has put a partial clinical hold on a phase Ib and phase I/II b trials evaluating Tecentriq, due to safety issues. A partial hold was put due to emerging safety data from clinical trials evaluating Merck & Co.’s (MRK - Free Report) Keytruda in combination with Celgene Corporation’s (CELG - Free Report) Revlimid and Pomalyst.

Roche also announced that the EC has approved a label expansion of Gazyvaro. The drug has been approved in combination with chemotherapy, followed by Gazyvaro maintenance in patients achieving a response, as a new treatment for previously untreated advanced follicular lymphoma.

The approval was based on results from the the phase III GALLIUM study which showed show superior progression-free survival over MabThera.

We note that the drug was approved in combination with chlorambucil, for patients with previously untreated chronic lymphocytic leukaemia with comorbidities that make them unsuitable for full-dose fludarabine-based therapy in 2014. Gazyvaro was also approved in combination with bendamustine, followed by Gazyvaro maintenance, in patients with follicular lymphoma who did not respond or who progressed during or up to six months after treatment with MabThera or a MabThera-containing regimen.

In addition, the EC approved Actemra/RoActemra (tocilizumab) for the treatment of giant cell arteritis (GCA) making it the first therapy approved for the treatment of GCA in Europe as per Roche. The drug was also approved in the Unites States for this indication in May 2017. Actemra is approved for the treatment of adult patients with moderate to severe active rheumatoid arthritis.


Roche’s stock has gained 15.2% year to date compared with industry’s gain of 20.1%.

Roche has a strong presence in the oncology market. The company dominates the breast cancer space due to the strong demand for its HER2 franchise drugs like Herceptin, Perjeta and Kadcyla.

However, sales of Avastin and Tarceva continue to decline. Generic competition for Xeloda continues to hurt sales. Competition from biosimilars looms large on Roche's key drugs like Herceptin, Avastin and Rituxan. The FDA has accepted Novartis AG’s (NVS - Free Report) Biologics License Application for a proposed biosimilar version of Rituxan. Hence, approval of new drugs and label expansion of existing drugs will bode well for Roche.

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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