Issue 35 – The Cancer Letter

Guest Editorial
Herceptin: What it took to make it happen
One day in 1996, in my role as chief science correspondent for NBC News, I was rummaging through the usual huge (pre-internet) pile of press releases on my desk and zeroed in on one: a phase III trial of a treatment for an aggressive type of breast cancer that was desperate to accrue volunteers.
Conversation with The Cancer Letter
In a globe-spanning action, FDA and regulators in Australia, Canada jointly approve endometrial carcinoma therapy
In the first regulatory action of its kind, FDA and drug approval authorities in Canada and Australia simultaneously approved a new treatment for patients with endometrial carcinoma.
Real-World Evidence
FDA begins technology overhaul in preparation for tsunami of data and real-world evidence
To keep up with an increasingly data-rich health ecosystem, FDA is implementing a multi-year strategic plan to modernize its technology infrastructure—boosting cloud capabilities and building sophisticated data analytics for using real-world evidence to support regulatory decisions.
Senate committee recommends $3 billion increase for NIH funding
The Senate Committee on Appropriations Sept. 18 proposed a $3 billion raise for NIH in the 2020 fiscal year.
Conversation with The Cancer Letter
Fred Hutch’s Gilliland to step down in 2020 as part of what he sees as generational change
D. Gary Gilliland, president and director of Fred Hutchinson Cancer Research Center, plans to step down in 2020, the cancer center announced Sept. 17.
In Brief
- SU2C to spend $6 million on two trials in breast, prostate cancer
- Broxmeyer receives Cord Blood Association’s Lifetime Achievement Award
- Roswell Park gets $6.42 million DoD grant for immunotherapy platform
- UCLA receives grant to develop immunotherapies for glioblastoma
- NCORP participants receive recognition at annual meeting
- Former FDA chief Gottlieb joins FasterCures Advisory Board
Real-World Evidence
Challenges to leveraging real-world evidence for FDA approval
The number of approved cancer therapies continues to rise, with 63 cancer drugs launched within the past five years.
Clinical Roundup
- Higher patient volumes associated with longer survival in multiple myeloma
- Phase III QUAZAR AML-001 study meets OS endpoint
- Darzalex shows high response rate, depth of response in multiple myeloma transplant-eligible patients
- ‘Scoop’ pathway leads to better health outcomes, lower costs in cancer care
- OVA1 shows ovarian malignancy risk detection in African-American women
Drugs & Targets
- FDA approves Keytruda + Lenvima for advanced endometrial carcinoma
- FDA approves Erleada for metastatic castration-sensitive prostate cancer
- NCTN trials clinically meaningful and cost-effective, study finds
- Invitae offers no-charge genetic testing to patients with pancreatic cancer