Stomach cancer
The first major deal of JPM 2025 will give GSK a promising small molecule drug for gastrointestinal stromal tumors.
An FDA committee’s September 2024 vote to limit the use of Merck’s Keytruda and BMS’ Opdivo in stomach and esophageal cancers based on PD-L1 expression levels reflects an emerging trend that leverages ever-maturing datasets.
The regulator’s approval on Friday of Vyloy for gastric or gastroesophageal junction cancer makes it the first and only claudin 18.2–targeted therapy approved in the U.S. for these indications, according to Astellas.
The FDA’s Oncology Drugs Advisory Committee voted near-unanimously that the benefits of PD-1 inhibitors like Keytruda and Opdivo in PD-L1 low patients do not outweigh the risks.
If approved, the potential restrictions would impact Merck’s Keytruda and Bristol Myers Squibb’s Opdivo, which are marketed for the first-line treatment of several types of stomach cancer regardless of PD-L1 expression.
The Oncologic Drugs Advisory Committee in a Sept. 26 meeting will discuss whether the regulator should restrict approval of checkpoint inhibitors based on PD-L1 expression levels.
Merck and Kelun-Biotech’s antibody-drug conjugate achieved a 22% objective response rate and 80.5% disease control rate in heavily pretreated patients with gastric or gastroesophageal junction cancer.
After several delays, BeiGene on Thursday finally secured the FDA’s approval for its PD-1 inhibitor Tevimbra for the treatment of unresectable or metastatic esophageal squamous cell carcinoma.
With the investment in the plant, Daiichi Sankyo is looking to create new laboratories for its antibody-drug conjugates used to develop and manufacture therapies for breast, lung and stomach cancers.
PRESS RELEASES