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Results For "mutation"

221 News Found

Enhertu approved in China as first HER2-directed therapy for patients with HER2-mutant metastatic NSCLC
Drug Approval | October 16, 2024

Enhertu approved in China as first HER2-directed therapy for patients with HER2-mutant metastatic NSCLC

Enhertu demonstrated clinically meaningful efficacy in previously treated patients


Bayer starts Phase III trial in non-small cell lung cancer
Clinical Trials | August 30, 2024

Bayer starts Phase III trial in non-small cell lung cancer

First patient enrolled in the Phase III SOHO-02 trial of investigational agent BAY 2927088 in treatment-naïve patients with advanced NSCLC with HER2-activating mutations


Natco Pharma announces submission of TABRECTA to USFDA
Drug Approval | August 30, 2024

Natco Pharma announces submission of TABRECTA to USFDA

TABRECTA is the brand of Novartis. Natco believes it is the first company to have filed a substantially-complete ANDA


Imfinzi approved in the US for the treatment of resectable non-small cell lung cancer
Drug Approval | August 17, 2024

Imfinzi approved in the US for the treatment of resectable non-small cell lung cancer

Based on AEGEAN Phase III trial results which showed Imfinzi-based regimen reduced the risk of recurrence, progression or death by 32% vs. neoadjuvant chemotherapy alone


Olverembatinib approved for commercialization in Macau China
Drug Approval | July 09, 2024

Olverembatinib approved for commercialization in Macau China

Olverembatinib, a novel drug developed by Ascentage Pharma with support from the National Major New Drug Development program


Tagrisso with the addition of chemotherapy approved in Japan as new 1st-line treatment for patients with EGFR-mutated advanced lung cancer
Drug Approval | June 26, 2024

Tagrisso with the addition of chemotherapy approved in Japan as new 1st-line treatment for patients with EGFR-mutated advanced lung cancer

Approval based on FLAURA2 results which showed Tagrisso plus chemotherapy extended median progression-free survival by nearly 9 months vs. standard of care


Truqap plus Faslodex approved in the EU for patients with advanced ER-positive breast cancer
News | June 22, 2024

Truqap plus Faslodex approved in the EU for patients with advanced ER-positive breast cancer

Approval based on CAPItello-291 results which showed this combination reduced the risk of disease progression or death by 50% vs. Faslodex alone in a biomarker-altered population


Bristol Myers Squibb receives USFDA accelerated approval of Krazati in combination with Cetuximab for CRC
Drug Approval | June 22, 2024

Bristol Myers Squibb receives USFDA accelerated approval of Krazati in combination with Cetuximab for CRC

Second FDA approval for KRAZATI - reinforcing its potential across tumor types


Sumitomo Pharma presents new clinical data on DSP-5336 at the European Hematology Association 2024 Congress
News | June 20, 2024

Sumitomo Pharma presents new clinical data on DSP-5336 at the European Hematology Association 2024 Congress

DSP-5336, an Investigational Menin and Mixed-lineage Leukemia Inhibitor, is Being Evaluated in Patients with Relapsed or Refractory Acute Leukemia