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FDA approves TEVIMBRA-based regimen for HER2-positive gastric cancer
The Phase 3 HERIZON-GEA-01 trial reported median overall survival of 26.4 months, with progression-free survival of 12.4 months versus 8.1 months for the prior trastuzumab plus chemotherapy standard.
BeOne Medicines said the FDA approved TEVIMBRA in combination with ZIIHERA and chemotherapy as a first-line treatment for HER2-positive gastroesophageal adenocarcinoma.
According to Yahoo Finance, the approval is based on Phase 3 HERIZON-GEA-01 data, where patients receiving the regimen lived a median of 26.4 months, the longest survival benchmark yet reported for an immunotherapy-based approach in this setting regardless of PD-L1 status.
The trial randomized 914 patients across about 300 sites in more than 30 countries, and it also showed median progression-free survival of 12.4 months versus 8.1 months for trastuzumab plus chemotherapy. In a subgroup often considered harder to treat, PD-L1-negative patients had median survival of 29.7 months compared with 15.8 months on the older regimen.
The approval comes as the company pointed to momentum in hematology, including reported second-quarter revenue of $1.7 billion, up 30% year over year, and BRUKINSA global sales of $1.2 billion, up 31%, with raised full-year revenue guidance to $6.6 billion to $6.8 billion and an operating income outlook increased by $250 million.