Tagrisso (Osimertinib)- AstraZeneca’s non-small cell lung cancer drug backed off by The National Institute of Health and Care Excellence (NICE)
Category: Blog
Tagrisso does not meet the criteria set up by NICE’s to be considered as a life-extending treatment. Data suggest that patients who take Tagrisso live longer than their peers who receive Roche’s Tarceva (erlotinib) or AstraZeneca’s own Iressa (gefitinib). However, AstraZeneca was not able to share any information from a randomized clinical trial comparing Tagrisso to Boehringer Ingelheim’s Gilotrif (afatinib) which is the first choice, EGFR tyrosine kinase inhibitor and this may prove to be
In a phase II, multi-centre, randomized double blind placebo-controlled study, GemVax’s experimental drug ‘GV1001’ met its primary endpoint in moderate to severe Alzheimer’s patients. Primary endpoint in this study was SIB (Severe Impairment Battery) at week 24. SIB is a reliable cognitive measure for evaluating treatment response in advanced Alzheimer’s disease (AD). The SIB score of the control group treated with donepezil only decreased by 7.23, while that of the experimental group treated with GV1001
Multiple myeloma is the second most common blood cancer, with approximately 32,000 and 138,500 new diagnoses in the U.S. and world respectively. It is characterized by the proliferation of cancerous plasma cells (multiple myeloma cells) that crowd out healthy blood cells in the bone marrow, infiltrate other tissues and cause potentially life-threatening organ injury. Recent advances, such as CD38 antibody treatment, have increased life expectancy of patients from 3-4 years to 7-8 years. Despite this,
On Nov 25, the U.S. Food and Drug Administration granted accelerated approval to Oxbryta (voxelotor) for the treatment of sickle cell disease (SCD) in adults and pediatric patients 12 years of age and older. Unmet Medical Need ParametersUnmet Medical Need in sickle cell disease after SIKLOSUnmet Medical Need in sickle cell disease after OXBRYTA Treatment Adequacy Current treatment increases hemoglobin F levels in red blood cells (RBCs), decreasing neutrophils, increasing the water content of RBCs,
Unmet Medical Need Analysis of vaso-occlusive crisis in sickle cell disease: Approval of Adakveo (crizanlizumab-tmca)
Category: Blog
On May 15, the U.S. Food and Drug Administration approved Adakveo (crizanlizumab-tmca), a treatment to reduce the frequency of vaso-occlusive crisis – a common and painful complication of sickle cell disease that occurs when blood circulation is obstructed by sickled red blood cells – for patients age 16 years and older. Unmet Medical Need ParametersCurrent Unmet Medical Need in vaso-occlusive crisis in sickle cell diseaseUnmet Medical Need after Adakveo (crizanlizumab-tmca) Low to moderate unmet medical