Roche gets FDA approval for Alecensa in early lung cancer
This approval helps address an urgent unmet need, with about half of people living with early-stage NSCLC experiencing disease recurrence following surgery, despite adjuvant chemotherapy
This approval helps address an urgent unmet need, with about half of people living with early-stage NSCLC experiencing disease recurrence following surgery, despite adjuvant chemotherapy
If approved, enfortumab vedotin with KEYTRUDA would be the first combination in China to offer an alternative to chemotherapy
Decision marks the first approval in Europe for an anti-PD-1/L1 therapy in resectable NSCLC based on positive overall survival results
Pivotal trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall and progression-free survival
Approval based on results from the Phase 3 KEYNOTE-859 trial, which demonstrated significant improvement in overall survival in these patients versus chemotherapy alone
With the establishment of five different precious metals alloy powder production methods
Approval based on DESTINY-Lung02 results where AstraZeneca and Daiichi Sankyo’s Enhertu demonstrated a confirmed objective response rate of 49% and median duration of response of 16.8 months in previously treated patients
In the Phase 3 LIBRETTO-431 study, Retevmo more than doubled progression-free survival (PFS) compared to chemotherapy plus pembrolizumab in patients with advanced or metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC)
Merck to pay Daiichi Sankyo a $4 billion upfront payment in addition to $1.5 billion in continuation payments over the next 24 months
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