The Swissmedic has recently approved several new treatment options for gastric and biliary cancers, marking a substantial advancement in oncological care for patients with these challenging conditions.
Trastuzumab Deruxtecan
Trastuzumab deruxtecan has been approved as a monotherapy for adult patients with locally advanced or metastatic HER2-positive gastric adenocarcinoma or gastro-oesophageal junction adenocarcinoma. This approval is specific to patients who have experienced disease progression during or after first-line treatment with trastuzumab and chemotherapy. The approval of trastuzumab deruxtecan provides a new targeted therapy option for patients whose cancers are resistant to initial treatments, potentially improving outcomes in this difficult-to-treat population.
Nivolumab
Nivolumab has received approval for use in combination with oxaliplatin- and fluoropyrimidine-based chemotherapy for the first-line treatment of adult patients with unresectable, locally advanced, or metastatic gastric adenocarcinoma, gastro-oesophageal junction adenocarcinoma, or distal oesophagus adenocarcinoma. This treatment is indicated for patients whose tumors express a PD-L1 Combined Positive Score (CPS) of 10 or greater. The combination of nivolumab with chemotherapy offers a new front-line treatment strategy that leverages the immune system to enhance the effectiveness of conventional chemotherapy.
Pembrolizumab
Pembrolizumab has been approved in combination with trastuzumab, fluoropyrimidine, and platinum-based chemotherapy for the first-line treatment of adults with locally advanced, unresectable, or metastatic HER2-positive gastric adenocarcinoma or gastro-oesophageal junction adenocarcinoma whose tumors express PD-L1 with a CPS of 1 or greater. This approval introduces a new immunotherapy-based regimen that combines multiple targeted and cytotoxic agents to tackle these aggressive cancers.
In addition, pembrolizumab is now approved for use in combination with gemcitabine and cisplatin for the first-line treatment of adult patients with locally advanced, unresectable, or metastatic biliary carcinoma. This combination offers a new therapeutic option that combines the immune-enhancing effects of pembrolizumab with established chemotherapeutic agents, providing hope for improved outcomes in biliary carcinoma, a cancer with limited treatment options.
These approvals represent significant advancements in the treatment landscape for gastric, gastro-oesophageal junction, and biliary cancers, offering hope for improved survival and quality of life for patients facing these challenging conditions.
References:
- swissmedicinfo.ch
FDA Approval
