Pharma Business - August 14, 2019
AstraZeneca’s Calquence granted Breakthrough Therapy Designation in the US
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for Calquence (acalabrutinib) as a monotherapy treatment for adult patients with chronic lymphocytic leukaemia (CLL). “This is an important regulatory milestone for our work in haematology and for patients living with chronic lymphocytic leukaemia, a life-threatening disease. The Breakthrough Therapy Designation acknowledges […]
Clinical Trials - August 12, 2019
Positive results about AstraZeneca’s Tagrisso
The company has announced positive overall survival (OS) results from the Phase III FLAURA trial, a randomized, double-blinded, multi-centre trial of Tagrisso (osimertinib) in previously-untreated patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) mutations. Tagrisso showed a statistically-significant and clinically-meaningful improvement in OS, a secondary endpoint […]
Clinical Trials - August 8, 2019
AstraZeneca’s PAOLA-1 trial met primary endpoint
AstraZeneca and MSD have announced positive results from the Phase III PAOLA-1 trial in women with advanced ovarian cancer. The trial, in the 1st-line maintenance setting, compared Lynparza(olaparib) added to standard-of-care (SoC) bevacizumab vs. bevacizumab alone in women with or without BRCA gene mutations. The second positive Phase III trial with Lynparza The trial met […]
Pharma Business - August 6, 2019
AstraZeneca’s Imfinzi granted US Orphan Drug Designation
In the middle of July the US Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to Imfinzi (durvalumab) for the treatment of small cell lung cancer (SCLC). About SCLC SCLC constitutes about 15% of all lung cancer diagnoses. It is the most aggressive type of lung cancer with only 6% of patients alive […]
Clinical Trials - June 30, 2019
Positive results from AstraZeneca’s Imfinzi trial
The company has announced positive overall survival (OS) results from the Phase III CASPIAN trial with Imfinzi in 1st-line extensive-stage small cell lung cancer (SCLC). A planned interim analysis conducted by an Independent Data Monitoring Committee concluded that the trial has met its primary endpoint by showing a statistically-significant and clinically-meaningful improvement in OS in […]
Pharma Business - June 18, 2019
AstraZeneca’s Lynparza approved in the EU & Japan
AstraZeneca and MSD have announced that the European Commission (EC) and the Japanese Ministry of Health, Labour and Welfare have approved Lynparza (olaparib) as a 1st-line maintenance treatment for women with BRCA-mutated advanced ovarian cancer. The licensed indication is as a maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or […]
