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89 News Found

Roche gets FDA approval for Alecensa in early lung cancer
Drug Approval | April 22, 2024

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


NMPA accepts supplemental Biologics License Application for enfortumab vedotin with Keytruda for treatment of bladder cancer
Drug Approval | March 30, 2024

NMPA accepts supplemental Biologics License Application for enfortumab vedotin with Keytruda for treatment of bladder cancer

If approved, enfortumab vedotin with KEYTRUDA would be the first combination in China to offer an alternative to chemotherapy


EC approves Merck’s Keytruda plus chemotherapy as neoadjuvant treatment for non-small cell lung cancer
Drug Approval | March 28, 2024

EC approves Merck’s Keytruda plus chemotherapy as neoadjuvant treatment for non-small cell lung cancer

Decision marks the first approval in Europe for an anti-PD-1/L1 therapy in resectable NSCLC based on positive overall survival results


EMA validates Type II variation application for enfortumab vedotin with pembrolizumab for treatment of bladder cancer
Drug Approval | January 29, 2024

EMA validates Type II variation application for enfortumab vedotin with pembrolizumab for treatment of bladder cancer

Pivotal trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall and progression-free survival


FDA approves Merck’s Keytruda plus chemotherapy as first line treatment for locally advanced Metastatic HER2-Negative Gastric
Drug Approval | November 17, 2023

FDA approves Merck’s Keytruda plus chemotherapy as first line treatment for locally advanced Metastatic HER2-Negative Gastric

Approval based on results from the Phase 3 KEYNOTE-859 trial, which demonstrated significant improvement in overall survival in these patients versus chemotherapy alone


Tanaka develops first high entropy precious metals alloy powder
News | October 30, 2023

Tanaka develops first high entropy precious metals alloy powder

With the establishment of five different precious metals alloy powder production methods


Enhertu approved in the EU as the first HER2-directed therapy for patients with HER2-mutant advanced non-small cell lung cancer
Drug Approval | October 26, 2023

Enhertu approved in the EU as the first HER2-directed therapy for patients with HER2-mutant advanced non-small cell lung cancer

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


Lilly's Retevmo phase 3 results in RET fusion-positive non-small cell lung cancer
News | October 26, 2023

Lilly's Retevmo phase 3 results in RET fusion-positive non-small cell lung cancer

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)


Daiichi Sankyo, Merck collaborate to develop and commercialize three Daiichi Sankyo DXd ADCs
News | October 20, 2023

Daiichi Sankyo, Merck collaborate to develop and commercialize three Daiichi Sankyo DXd ADCs

Merck to pay Daiichi Sankyo a $4 billion upfront payment in addition to $1.5 billion in continuation payments over the next 24 months