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Results For "epidermal-growth-factor-receptor"

41 News Found

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
Clinical Trials | 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


Lynparza reduced risk of death by 32% in the adjuvant treatment of patients with breast cancer
Drug Approval | March 17, 2022

Lynparza reduced risk of death by 32% in the adjuvant treatment of patients with breast cancer

First PARP inhibitor to demonstrate overall survival benefit in early breast cancer


Sandoz submits Biologics License Application for proposed biosimilar trastuzumab to US FDA
Biotech | December 21, 2021

Sandoz submits Biologics License Application for proposed biosimilar trastuzumab to US FDA

Trastuzumab is monoclonal antibody used to treat human epidermal growth factor receptor 2 positive (HER2+) breast cancer and metastatic gastric cancers


Novartis’ Kisqali data indicates longest median survival in advanced breast cancer
Drug Approval | September 20, 2021

Novartis’ Kisqali data indicates longest median survival in advanced breast cancer

With the MONALEESA-2 final analysis, only Kisqali has reported statistically significant overall survival (OS) benefit with an aromatase inhibitor for postmenopausal women with HR+/HER2- advanced breast cancer in the first-line (1L) setting


U.S. FDA approves Thermo Fisher Scientific’s Oncomine Dx target test
Medical Device | September 16, 2021

U.S. FDA approves Thermo Fisher Scientific’s Oncomine Dx target test

It approves tissue-based NGS companion diagnostic for Takeda's targeted therapy for NSCLC patients with EGFR Exon20 insertion mutations


Pillar Biosciences Receives Premarket Approval from FDA for its oncoReveal Dx Lung and Colon Cancer Assay
Drug Approval | August 10, 2021

Pillar Biosciences Receives Premarket Approval from FDA for its oncoReveal Dx Lung and Colon Cancer Assay

The product can be used by any lab that conducts NGS testing, making precision medicine accessible to all cancer patients


Zydus Cadila receives tentative approval from USFDA for lung cancer drugs
Policy | June 03, 2021

Zydus Cadila receives tentative approval from USFDA for lung cancer drugs

Osimertinib works by slowing or stopping the growth of cancer cells and binds to a certain protein (epidermal growth factor receptor-EGFR) in some tumors