Roche Holdings AG RHHBY announced that the FDA has approved a label expansion of its immuno-oncology drug Tecentriq (atezolizumab). The drug has been approved in combination with chemotherapy (Abraxane [paclitaxel protein-bound; nab-paclitaxel] and carboplatin) for the initial (first-line) treatment of adults with metastatic, non-squamous, non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
The approval was based on positive results from the phase III IMpower130 study, which showed that Tecentriq in combination with chemotherapy demonstrated a significant overall survival and progression-free survival benefit.
The label expansion of the drug in this lucrative space should boost sales for the company.
We note that Tecentriq is already approved in the United States in combination with Avastin, paclitaxel and carboplatin for the first-line treatment of adults with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumor aberrations. The drug is also approved by the FDA to treat adults with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. It is also approved in the United States in combination with carboplatin and etoposide (chemotherapy) for the initial treatment of adults with extensive-stage small cell lung cancer (ES-SCLC).
Meanwhile, Roche has an extensive development program for Tecentriq as a monotherapy or in combination with other drugs. These include nine phase III studies underway across different types of lung cancer, and multiple ongoing and planned phase III studies in genitourinary, skin, breast, gastrointestinal, gynecological, and head and neck cancers.
While the NSCLC market presents immense potential, competition is stiff in this space. Immuno-oncology therapies like Merck’s MRK Keytruda, AstraZeneca’s AZN Imfinzi and Bristol-Myers’ BMY Opdivo are approved for various types of lung cancer.
Shares of Roche have gained 22.8% so far this year compared with the industry’s growth of 5.7%.
Roche has one of the strongest oncology portfolios. The company’s efforts to develop the portfolio beyond oncology have been impressive as well.
Roche currently 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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