What is the story about?
What's Happening?
Agenus Inc. has announced that its investigational combination therapy, botensilimab plus balstilimab (BOT/BAL), is now available to eligible patients in France under the compassionate access framework for refractory microsatellite-stable metastatic colorectal cancer. The French National Agency of Medicines and Health Products Safety has listed the therapy, which remains investigational and is not approved for commercial marketing. The compassionate access allows hospitals to use the therapy with full reimbursement, providing a new option for patients with limited treatment alternatives.
Why It's Important?
The approval of BOT/BAL under France's compassionate access framework is significant for patients with refractory MSS metastatic colorectal cancer, a population with few effective treatment options. The therapy has shown durable activity in clinical trials, offering hope for improved survival rates and quality of life. This development underscores the importance of international collaboration in expanding access to innovative cancer treatments and highlights Agenus' role in advancing immuno-oncology therapies.
What's Next?
Agenus plans to initiate a global Phase 3 trial, BATTMAN, in late 2025 to further evaluate the efficacy of BOT/BAL in refractory MSS metastatic colorectal cancer. The trial aims to support broader availability and confirm the therapy's benefits, potentially leading to regulatory approval and expanded access for patients worldwide.
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