Merck’s KEYTRUDA & WELIREG combo shows breakthrough results in kidney cancer trial
Merck emphasized the broader significance of the findings
Merck emphasized the broader significance of the findings
Zydus has in-licensed FYB206, a proposed biosimilar to immuno-oncology therapy Keytruda (pembrolizumab), exclusively from Formycon AG for the U.S. and Canadian markets
KEYTRUDA had previously met its primary endpoint of progression-free survival in all patients
KEYTRUDA QLEX is contraindicated in patients with known hypersensitivity to its components
The study evaluated patients with stage III/IV melanoma after complete tumor resection
KRAS G12C-mutant advanced or metastatic nonsquamous non-small cell lung cancer
Formycon AG will develop, register, manufacture and supply the product, while Zydus Lifesciences Global FZE, United Arab Emirates will be responsible for the commercialization of FYB206 in the defined territories
While Merck can appeal, Halozyme said it expects the order to hold
The submissions are supported by data from the Phase 3 KEYNOTE-905 trial
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