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Roche's (RHHBY) Tecentriq Gets EC Nod for First-Line NSCLC
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Swiss pharma company, Roche (RHHBY - Free Report) announced that the European Commission (EC) has approved and granted marketing authorization to immuno-oncology drug, Tecentriq in combination with Avastin, paclitaxel and carboplatin for the first-line treatment of adults with metastatic non-squamous non-small cell lung cancer (NSCLC).
The approval includes EGFR mutant or ALK-positive NSCLC after failure of a targeted therapy.
The EC approval was based on positive results from the phase III IMpower150 study, which showed that Tecentriq in combination with Avastin and chemotherapy enabled patients live significantly longer as compared to the combination of Avastin and chemotherapy. The safety profile of the Tecentriq combination was consistent with that observed in previous studies.
The label expansion of the drug should further boost sales, given the market potential for first-line NSCLC, which accounts for 85% of all lung cancer cases in the world.
We remind investors that Tecentriq is already approved in the European Union and the United States for previously treated metastatic NSCLC and for certain types of untreated or previously treated metastatic urothelial carcinoma (mUC). The FDA recently approved Tecentriq in combination with Avastin and chemotherapy for the initial treatment of people with metastatic non-squamous NSCLC.
Roche is working to expand the drug’s label further. Nine phase III lung cancer studies are ongoing, evaluating Tecentriq alone or in combination with other medicines.
However, competition is stiff in the promising first-line NSCLC market with the likes of Merck’s (MRK - Free Report) Keytruda.
Earlier, Roche announced that it submitted a supplemental New Drug Application (sNDA) for leukemia drug, Venclexta in combination with of Gazyva. The company is seeking label expansion of the drug for the treatment of previously untreated chronic lymphocytic leukemia (CLL) and co-existing medical conditions.
The FDA is reviewing the application under the Real-Time Oncology Review pilot program, which should speed up the process to ensure availability of safe and effective treatments for patients as early as possible.
We remind investors that the combination was earlier granted Breakthrough Therapy designation by the FDA, which should expedite the review process.
Roche has a collaboration agreement with AbbVie, Inc. (ABBV - Free Report) for Venclexta. Both the companies jointly commercialize the drug in the United States, while AbbVie commercializes it outside the United States.
Venclexta is already approved for the treatment of CLL in adults with or without 17p deletion who have received at least one prior treatment.
Roche’s stock has gained 11.5% in the past six months compared with the industry’s growth of 3.4%.
Approval of new drugs and label expansion of existing drugs bode well for the company as biosimilars pose stiff competition for some of its key drugs.
Separately, Roche announced that it has commenced a cash tender offer for all of the outstanding shares of common stock of Spark Therapeutics, Inc. at $114.50 per share. The acquisition will strengthen Roche’s position in the hemophilia market.
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Roche's (RHHBY) Tecentriq Gets EC Nod for First-Line NSCLC
Swiss pharma company, Roche (RHHBY - Free Report) announced that the European Commission (EC) has approved and granted marketing authorization to immuno-oncology drug, Tecentriq in combination with Avastin, paclitaxel and carboplatin for the first-line treatment of adults with metastatic non-squamous non-small cell lung cancer (NSCLC).
The approval includes EGFR mutant or ALK-positive NSCLC after failure of a targeted therapy.
The EC approval was based on positive results from the phase III IMpower150 study, which showed that Tecentriq in combination with Avastin and chemotherapy enabled patients live significantly longer as compared to the combination of Avastin and chemotherapy. The safety profile of the Tecentriq combination was consistent with that observed in previous studies.
The label expansion of the drug should further boost sales, given the market potential for first-line NSCLC, which accounts for 85% of all lung cancer cases in the world.
We remind investors that Tecentriq is already approved in the European Union and the United States for previously treated metastatic NSCLC and for certain types of untreated or previously treated metastatic urothelial carcinoma (mUC). The FDA recently approved Tecentriq in combination with Avastin and chemotherapy for the initial treatment of people with metastatic non-squamous NSCLC.
Roche is working to expand the drug’s label further. Nine phase III lung cancer studies are ongoing, evaluating Tecentriq alone or in combination with other medicines.
However, competition is stiff in the promising first-line NSCLC market with the likes of Merck’s (MRK - Free Report) Keytruda.
Earlier, Roche announced that it submitted a supplemental New Drug Application (sNDA) for leukemia drug, Venclexta in combination with of Gazyva. The company is seeking label expansion of the drug for the treatment of previously untreated chronic lymphocytic leukemia (CLL) and co-existing medical conditions.
The FDA is reviewing the application under the Real-Time Oncology Review pilot program, which should speed up the process to ensure availability of safe and effective treatments for patients as early as possible.
We remind investors that the combination was earlier granted Breakthrough Therapy designation by the FDA, which should expedite the review process.
Roche has a collaboration agreement with AbbVie, Inc. (ABBV - Free Report) for Venclexta. Both the companies jointly commercialize the drug in the United States, while AbbVie commercializes it outside the United States.
Venclexta is already approved for the treatment of CLL in adults with or without 17p deletion who have received at least one prior treatment.
Roche’s stock has gained 11.5% in the past six months compared with the industry’s growth of 3.4%.
Approval of new drugs and label expansion of existing drugs bode well for the company as biosimilars pose stiff competition for some of its key drugs.
Separately, Roche announced that it has commenced a cash tender offer for all of the outstanding shares of common stock of Spark Therapeutics, Inc. at $114.50 per share. The acquisition will strengthen Roche’s position in the hemophilia market.
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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This outperformance has not just been a recent phenomenon. From 2000 – 2018, while the S&P averaged +4.8% per year, our top strategies averaged up to +56.2% per year.
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