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SOUTH SAN FRANCISCO - The U.S. Food and Drug Administration has approved Tecentriq (atezolizumab) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) in combination with lurbinectedin (Zepzelca) for the maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC), Genentech announced. The approval marks another milestone for Genentech’s parent company Roche (RHHBY), which InvestingPro data shows is a prominent player in the pharmaceuticals industry with a substantial market capitalization of $306 billion and impressive gross profit margins of nearly 75%.
The approval applies to patients whose disease has not progressed after first-line induction therapy with Tecentriq or Tecentriq Hybreza, carboplatin and etoposide. This marks the first and only combination therapy approved for first-line maintenance treatment of ES-SCLC.
The FDA decision was based on results from the Phase III IMforte study, which demonstrated that the Tecentriq and lurbinectedin combination reduced the risk of disease progression or death by 46% compared to Tecentriq maintenance therapy alone. The combination also reduced the risk of death by 27%. With annual revenue exceeding $80 billion and an "GREAT" financial health score according to InvestingPro, Roche maintains strong R&D capabilities to develop such breakthrough therapies.
Following 3.2 months of induction therapy, median overall survival for patients receiving the combination regimen was 13.2 months versus 10.6 months for those receiving Tecentriq alone. Median progression-free survival was 5.4 months for the combination versus 2.1 months for Tecentriq monotherapy.
"The Tecentriq and lurbinectedin combination reduced the risk of disease progression or death by nearly half," said Levi Garraway, chief medical officer at Genentech, according to the company’s press release.
The National Comprehensive Cancer Network Clinical Practice Guidelines have been updated to include the regimen as a category 2A and preferred option for maintenance treatment of people with ES-SCLC. For investors seeking deeper insights into pharmaceutical companies’ growth potential and market positioning, InvestingPro offers comprehensive analysis of 1,400+ stocks, including detailed Pro Research Reports that transform complex financial data into actionable intelligence.
The approval builds on Tecentriq’s established role in ES-SCLC treatment. In 2019, the FDA approved Tecentriq in combination with chemotherapy for first-line treatment of adults with ES-SCLC, which was the first new treatment option in two decades for this patient population.
In other recent news, Genentech faced a setback as the U.S. Food and Drug Administration rejected its application for Columvi, intended for second-line treatment of diffuse large B-cell lymphoma. The FDA’s Complete Response Letter indicated that data from the STARGLO study was insufficient to support the proposed use for patients ineligible for autologous stem cell transplant. Meanwhile, Flatiron Health announced a leadership change with Nathan Hubbard appointed as the new Chief Executive Officer. Hubbard, who has extensive experience in biopharma and healthcare, will succeed Carolyn Starrett, who will now serve as a senior advisor. These developments highlight significant shifts within both companies as they navigate challenges and transitions in their respective fields.
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