Mehmet Oz, Robert F. Kennedy Jr., Marty Makary, Jayanta Bhattacharya, and Vinayak Prasad at an FDA Roundtable on Cell and Gene Therapy, June 5.Speaking at an FDA Roundtable on Cell and Gene Therapy, FDA Commissioner Marty Makary questioned the construct of “levels of evidence” as artificial and dogmatic, saying that n-of-1 “stories” can drive regulatory decisions.
RWE and phase I data support the role of Orserdu for ER+, HER2- advanced or metastatic breast cancer
The Menarini Group and Stemline Therapeutics will present new and expanded data on Orserdu at the upcoming 2024 San Antonio Breast Cancer Symposium, held from Dec. 10-13. The company will bring real-world progression-free survival results of Orserdu in adult patients with ER+/HER2-, advanced or metastatic breast cancer. Additionally, the company will present updated efficacy results of elacestrant plus abemaciclib, along with a pooled safety analysis from phase Ib/2 of both the ELECTRA and ELEVATE trials.
COTA joined Panalgo’s Partner Network to make their hematologic oncology data available via Panalgo’s Instant Health Data Analytics platform.
Unquestionably, a child’s cancer diagnosis weighs heavily on the parents’ minds. But now, an analysis of nearly 30,000 U.S. families has quantified how often parents of children with cancer use mental health services.
COTA, a leader in real-world data and analytics for oncology, is entering a collaboration with Sanofi to use RWD and artificial intelligence to increase the speed of oncology trials, including for multiple myeloma.
Non-classical mutations are present in 20-30% of all patients with epidermal growth factor receptor-mutated non-small cell lung cancer, according to an analysis of real-world evidence presented by Black Diamond Therapeutics, Inc. at the American Association of Cancer Research annual meeting.
Michael EggerChristopher ManzSerena PhillipsMichael Egger, Christopher Manz, and Serena Phillips received the 2023 Real-World Data Impact Award from the American Cancer Society and Flatiron Health.
As artificial intelligence becomes an indispensable tool in cancer research, drug sponsors and researchers should focus on building and utilizing rich real-world evidence databases that can be used to complement clinical trials.
Patients treated with first-line immunotherapy for advanced non-small cell lung cancer showed similar results in terms of survival, progression-free survival, and treatment duration, regardless of race or ethnicity, even with differences in income and insurance, a study published in the Journal of the National Comprehensive Cancer Network showed.
Today’s traditional research model relies on incremental innovation that builds upon the shoulders of other researchers’ work, making small but steady strides. Occasionally, leaps are made by researchers who develop new classes of therapy such as stem cell transplant or CAR-T immunotherapy. But cancer patients may not have the luxury to wait 20 years for the traditional scientific process to evolve for their cancer. They can’t wait for a cure.
