Roche's Tecentriq Gets FDA Approval for Metastatic NSCLC
Roche RHHBY announced that the FDA has approved yet another indication for Tecentriq (atezolizumab).
The immuno-oncology drug has been approved as a first-line monotherapy for certain patients with metastatic non-small cell lung cancer (NSCLC).
Precisely, the drug has been approved as a first-line (initial) treatment for adults with metastatic NSCLC whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating [IC] covering ≥ 10% of the tumor area [IC ≥ 10%]), as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.
The approval presents a new chemotherapy-free option to lung cancer patients that can help prolong their lives and be administered on a flexible dosing schedule, including an option for once-a-month Tecentriq infusions.
Tecentriq is the first and only single-agent cancer immunotherapy with three dosing options, allowing administration every two, three or four weeks. The supplemental Biologics License Application for the Tecentriq monotherapy was granted Priority Review. The approval was based on an interim analysis from the phase III IMpower110 study, which showed that Tecentriq monotherapy improved overall survival (OS) by 7.1 months compared with chemotherapy in patients with high PD-L1 expression.
Notably, Tecentriq has received four approvals across NSCLC, including as a single agent or in combination with targeted therapies and/or chemotherapies in the United States. It is also approved in combination with carboplatin and etoposide (chemotherapy) for the first-line treatment of adults with extensive-stage small cell lung cancer.
The label expansion into additional indications will boost sales of the drug, which came in at CHF 644 million in the first quarter.
Lung cancer is the leading cause of cancer deaths globally and NSCLC is the most prevalent type, accounting for around 85% of all cases.
Meanwhile, Roche is also evaluating Tecentriq in multiple ongoing and planned phase III studies across lung, genitourinary, skin, breast, gastrointestinal, gynecological, and head and neck cancers. These include studies evaluating the drug both alone and in combination with other medicines.
Roche’s stock has gained 11% in the year so far against the industry’s decline of 0.7%.
However, the drug faces stiff competition from Merck’s MRK Keytruda and Bristol-Myers’ BMY Opdivo. AstraZeneca’s AZN Imfinzi is also approved for lung cancer. The FDA recently approved the combination of its blockbuster immuno-oncology drug Opdivo and Yervoy for the indication of first-line treatment of adult patients with metastatic NSCLC.
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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