Roche Breast Cancer Drug Receives FDA Approval
The US Food and Drug Administration announced on Friday that it had approved Kadcyla, also known as ado-trastuzumab emtansine, for patients whose cancer cells contain increased amounts of a protein known as HER2.
The drug's label will carry a boxed warning, the most serious possible, of the drug's potential to cause liver and heart damage and death. The drug can also cause life-threatening birth defects.
In clinical trials, patients who took the drug, known during its development process as T-DM1, survived an average of 30.9 months, compared with 25.1 months in a control group.
Analysts at Jefferies have estimated the drug could generate annual peak sales of $1.9 billion as usage in different settings increases.
Kadcyla works by attaching trastuzumab, sold under the brand name Herceptin, to a drug called DM1 that interferes with cancer cell growth, said Dr Richard Pazdur, Director of the FDA's Office of Hematology and Oncology Products.
“Kadcyla delivers the drug to the cancer site to shrink the tumor, slow disease progression and prolong survival,” he said. “It is the fourth approved drug that targets the HER2 protein.”
Breast cancer is the second leading cause of cancer-related death among women. An estimated 232,340 women will be diagnosed with the disease in 2013 and 39,620 will die from it, according to the National Cancer Institute. About 20 percent of breast cancer patients have increased amounts of the HER2 protein.
The most common side effects in patients treated with Kadcyla were nausea, fatigue, muscle and joint pain, increased liver enzymes, headache and constipation.
Vuram launches automated app to track COVID-19 supplies
A new app that tracks COVID-19 supplies in real time time has launched.
Built by hyper-automation services company Vuram, Trackable can monitor the progress of vaccines, oxygen cylinders, PPE, and masks as they move through the supply chain.
The app's features include street view to facilitate coordination between drivers, and trained facial recognition software powered by Microsoft Azure to ensure goods are only handled by authorised personnel.
Other functions include:
* Demand management for inventories, to prioritise deliveries using automation
* Demand analysis to predict sales trends based on stock levels
* Offline multilingual feature for drivers
* A dashboard to see the status and location of drivers
* Insights on how products are performing in real-time
The team at Vuram built Trackable as part of the Appian World 2021 Online Hackathon, where participants can take their ideas for innovative software and create a custom app. The tracking app went on to win the contest.
“Custom component building is at the heart of this application, and we focussed on making them more creative to provide an improved user experience" said Santosh Kumar, co-developer of Trackable.
"We are happy that we have managed to make it to the top in just a month. On behalf of Vuram, I thank the Appian Hackathon team for their efforts in conducting the event, and my hearty congratulations to all the winners."