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FDA accepts submission of olaparib in combination with abiraterone and prednisone for prostate cancer
Drug Approval | August 17, 2022

FDA accepts submission of olaparib in combination with abiraterone and prednisone for prostate cancer

First PARP inhibitor to demonstrate clinical benefit in radiographic progression-free survival in combination with a new hormonal agent with or without homologous recombination repair gene mutations


Enhertu approved in the US as the first HER2-directed therapy for patients with previously treated HER2-mutant metastatic non-small cell lung cancer
News | August 13, 2022

Enhertu approved in the US as the first HER2-directed therapy for patients with previously treated HER2-mutant metastatic non-small cell lung cancer

Based on DESTINY-Lung02 results which showed AstraZeneca and Daiichi Sankyo’s Enhertu reported a confirmed objective response rate of 57.7% in patients with HER2-mutant disease


ENHERTU approved in the U.S. as the first HER2 directed for low metastatic breast cancer
Drug Approval | August 09, 2022

ENHERTU approved in the U.S. as the first HER2 directed for low metastatic breast cancer

Based on DESTINY-Breast04 results which showed Daiichi Sankyo and AstraZeneca’s ENHERTU reduced risk of disease progression or death by 50% and increased overall survival by more than six months versus chemotherapy


HERTHENA-Lung02 Phase 3 trial of Patritumab Deruxtecan initiated in patients with EGFR-mutated metastatic non-small cell lung cancer
Diagnostic Center | August 09, 2022

HERTHENA-Lung02 Phase 3 trial of Patritumab Deruxtecan initiated in patients with EGFR-mutated metastatic non-small cell lung cancer

Patritumab deruxtecan is a specifically designed potential first-in-class HER3 directed antibody drug conjugate (ADC) discovered and being developed by Daiichi Sankyo.


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


DS-7300 Phase 2 Trial Initiated in Patients with Pretreated ExtensiveStage Small Cell Lung Cancer
News | July 21, 2022

DS-7300 Phase 2 Trial Initiated in Patients with Pretreated ExtensiveStage Small Cell Lung Cancer

DS-7300 is a specifically designed potential first-in-class B7-H3 directed antibody drug conjugate


Sumitomo Pharma Oncology receives Orphan Drug Designation for DSP-0390 for the treatment of brain cancer
News | July 18, 2022

Sumitomo Pharma Oncology receives Orphan Drug Designation for DSP-0390 for the treatment of brain cancer

The FDA's Orphan Drug Designation is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people


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


Novartis receives EC approval for Tabrecta for the treatment of non-small cell lung cancer
Drug Approval | June 24, 2022

Novartis receives EC approval for Tabrecta for the treatment of non-small cell lung cancer

Tabrecta is the number one prescribed targeted therapy for advanced NSCLC with alterations leading to METex14 skipping globally


FDA accepts application for Merck’s Keytruda as adjuvant therapy for Stage IB-IIIA lung cancer
Drug Approval | June 14, 2022

FDA accepts application for Merck’s Keytruda as adjuvant therapy for Stage IB-IIIA lung cancer

Acceptance based on results from the phase 3 KEYNOTE-091 trial