Roche Holding AG RHHBY recently announced that the European Commission (EC) has approved and granted marketing authorization to two indications of its immuno-oncology drug, Tecentriq (atezolizumab), in combination with chemotherapy. Shares of Roche have rallied 12.5% so far this year compared with the industry’s growth of 3.3%.
The EC approved and granted marketing authorization to Tecentriq, in combination with chemotherapy (carboplatin and etoposide), for the initial (first-line) treatment of adults with extensive-stage small-cell lung cancer (ES-SCLC). Tecentriq, in combination with chemotherapy, is the first and only cancer immunotherapy approved by the European Medicines Agency for the initial treatment of ES-SCLC —a difficult-to-treat cancer with limited treatment options.
This approval is supported by results from the phase III IMpower133 study, which showed that Tecentriq, in combination with chemotherapy, helped people live significantly longer compared with chemotherapy alone.
We note that, in March 2019, the FDA approved Tecentriq — in combination with chemotherapy — for the first-line treatment of ES-SCLC. With the FDA nod, Tecentriq becomes the first cancer immunotherapy approved for the initial treatment of ES-SCLC in the United States.
Separately, the EC also approved and granted marketing authorisation for Tecentriq, in combination with chemotherapy [carboplatin and Celgene’s CELG Abraxane], for the first-line treatment of adults with metastatic non-squamous non-small cell lung cancer (NSCLC) who do not have EGFR mutant or ALK-positive NSCLC. This approval is backed by results from the phase III IMpower130 study, which demonstrated that the Tecentriq combination therapy helped people live considerably longer compared with chemotherapy alone.
Tecentriq has already been approved for the treatment of patients with advanced bladder cancer, advanced lung cancer, and in combination with Avastin and chemotherapy for the preliminary treatment of people with metastatic non-squamous NSCLC.
Tecentriq (for multiple indications) recorded significant growth in sales during the first half of 2019. Upswing in sales was mainly witnessed in the United States, Europe and Japan. The latest approval of Tecentriq for the above-mentioned indications will further boost the drug’s sales.
Currently, Roche has nine Phase III lung cancer studies underway, evaluating Tecentriq alone or in combination with other medicines for different types of lung cancer.
Nevertheless, competition is stiff in the first-line NSCLC market. Merck’s MRK PD-L1 inhibitor, Keytruda, commanded a strong place in the first-line NSCLC market. Other PD-L1 inhibitors available in the market are AstraZeneca’s AZN Imfinzi and Pfizer’s Bavencio.
Roche carries a Zacks Rank #1 (Strong Buy), at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
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