Roche Holding AG RHHBY announced that the FDA has approved its regulatory application, looking for approval of its cancer immunotherapy — Tecentriq — in combination with chemotherapy for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC).
With this FDA nod, Tecentriq — a PD-L1 inhibitor — becomes the first cancer immunotherapy approved for the initial treatment of ES-SCLC, which is a difficult to treat cancer with limited treatment options.
This sBLA was based on results from the phase III IMpower133 study that met its overall survival (OS) and progression-free survival (PFS) co-primary endpoints, per the study protocol. Results from the study showed that the initial treatment with the combination of Tecentriq and chemotherapy (carboplatin and etoposide) enabled patients with ES-SCLC to live significantly longer as compared to chemotherapy alone. The combination also reduced the risk of disease worsening or death (PFS) in comparison to only chemotherapy.
Roche’s stock has rallied 8.9% this year so far, outperforming the industry’s rise of 3.7%.
Tecentriq is already 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.
Roche is working to expand the drug’s label further. The company currently has nine phase III lung cancer studies, evaluating Tecentriq alone or combined with other drugs.
Tecentriq sales came in at CHF 772 million during 2018, up 59%. A label expansion of the drug in the NSCLC market will further boost sales, given its potential.
However, competition is stiff in the first-line NSCLC market. Merck’s MRK PD-L1 inhibitor, Keytruda commanded a strong place in first-line NSCLC market. Bristol-Myers Squibb Company’s BMY PD-L1 inhibitor, Opdivo is also in the race for the first-line NSCLC treatment. However, the FDA extended its review period for the company’s application by three months and set a target action date of May 20, 2019. Other PD-L1 inhibitors available in the market are AstraZeneca’s AZN Imfinzi and Pfizer’s Bavencio.
Roche carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here .
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AstraZeneca PLC (AZN) : Free Stock Analysis Report
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