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37 News Found

Merck receives positive EU CHMP opinion for pembrolizumab plus Trastuzumab and Chemotherapy as first-line treatment for HER2-positive advanced gastric or gastroesophageal junction
Drug Approval | July 22, 2023

Merck receives positive EU CHMP opinion for pembrolizumab plus Trastuzumab and Chemotherapy as first-line treatment for HER2-positive advanced gastric or gastroesophageal junction

If approved, KEYTRUDA would be the first immunotherapy for the first-line treatment of HER2-positive advanced gastric or GEJ cancer in tumors expressing PD-L1 (CPS ?1) in the EU


Pembrolizumab + Trastuzumab and chemotherapy met primary endpoint as first line of treatment for GEJ
News | June 17, 2023

Pembrolizumab + Trastuzumab and chemotherapy met primary endpoint as first line of treatment for GEJ

Based on a subgroup analysis by PD-L1 expression from KEYNOTE-811, Merck is working with the US FDA to update the current indication for KEYTRUDA in HER2-positive gastric or GEJ adenocarcinoma


Zion Pharma inks agreement with Roche to develop and commercialize brain-penetrable compounds
News | May 10, 2023

Zion Pharma inks agreement with Roche to develop and commercialize brain-penetrable compounds

ZN-A-1041 was designed to be blood-brain-barrier-penetrant, and has the potential to treat or prevent the onset of brain metastases in patients with HER2-positive metastatic breast cancer


FDA accepts application for Merck’s Keytruda plus chemotherapy as first-line treatment for metastatic gastric
Drug Approval | April 14, 2023

FDA accepts application for Merck’s Keytruda plus chemotherapy as first-line treatment for metastatic gastric

Acceptance based on results from the Phase 3 KEYNOTE-859 trial, which showed significant overall survival benefit in these patients with HER2-negative disease, regardless of PD-L1 expression


Sun Pharma launches Palbociclib, a novel targeted therapy for advanced breast cancer
News | January 12, 2023

Sun Pharma launches Palbociclib, a novel targeted therapy for advanced breast cancer

Palbociclib has a unique mechanism of action which helps in delaying disease progression when co-administered with hormonal therapies


Jacobio Pharma to collaborate with Merck on clinical trial of JAB-21822
Diagnostic Center | October 13, 2022

Jacobio Pharma to collaborate with Merck on clinical trial of JAB-21822

This clinical study aims to evaluate the efficacy of JAB-21822 in combination with cetuximab in patients with KRAS G12C-mutated colorectal cancer.


Olaparib approved in Japan as adjuvant treatment for patients with high recurrent risk breast cancer
Drug Approval | August 26, 2022

Olaparib approved in Japan as adjuvant treatment for patients with high recurrent risk breast cancer

First and only PARP inhibitor to improve invasive disease-free survival, the primary endpoint, and overall survival, a key secondary endpoint of the OlympiA trial, in these patients


Sanofi updates on amcenestrant clinical development program
Diagnostic Center | August 18, 2022

Sanofi updates on amcenestrant clinical development program

The decision is based on the outcome of a prespecified interim analysis of the Phase 3 AMEERA-5 trial


LYNPARZA approved in the EU as adjuvant treatment for early breast cancer
Drug Approval | August 04, 2022

LYNPARZA approved in the EU as adjuvant treatment for early breast cancer

First and only PARP inhibitor to improve invasive disease-free survival, the primary endpoint, and overall survival, a key secondary endpoint, in these patients


Lynparza gets positive opinion from EU CHMP as adjuvant treatment for germline BRCA-mutated early breast cancer
Drug Approval | June 28, 2022

Lynparza gets positive opinion from EU CHMP as adjuvant treatment for germline BRCA-mutated early breast cancer

First and only PARP inhibitor to improve invasive disease-free survival in patients