Issue 44 – The Cancer Letter

FDA approves second drug for a site-agnostic indication; larotrectinib was tested across 17 cancer types
Vitrakvi (larotrectinib) aims to treat a very small group of people—some say fewer than 3,000 new patients a year in the U.S. And since these patients have diseases that span multiple tumor sites, finding them isn’t easy.
How we isolated the TRK oncogene
I was very surprised to see in an issue of the NEJM earlier this year that Loxo Oncology had developed a selective TRK inhibitor, larotrectinib, and even more surprised to learn that TRK fusions occur in about 1 percent of all human cancers.
Conversation with The Cancer Letter
Hyman: “This approval adds to the growing utility of sequencing in patients with cancer”
As Vitrakvi (larotrectinib) becomes the second drug to get FDA approval for a site-agnostic indication, physicians will have yet another reason to order sequencing, said David Hyman, chief of the Early Drug Development Service at Memorial Sloan Kettering Cancer Center and the principal investigator for a larotrectinib clinical trial that led to the approval.
Cancer groups: CMS proposal to lower drug prices would limit access for patients in “protected classes”
The Centers for Medicare and Medicaid Services has proposed a drug-pricing plan that administration officials say would offer lower cost options to seniors and provide support for the private sector to lower the cost of prescription drugs.
Guest Editorial
Reasons for hope for acute myeloid leukemia patients
On the eve of the Thanksgiving holiday, FDA delivered a flurry of decisions: approvals for two therapies—venetoclax and glasdegib—to treat a deadly form of blood cancer called acute myeloid leukemia (AML), and a priority review designation for another therapy—quizartinib—to treat the same disease. A fourth therapy to treat AML—gilteritinib—received an FDA approval on Nov. 28.
In Brief
- The Pancreatic Cancer Collective awards $7 million in first-round “New Therapies Challenge” grants
- Oren Cahlon named associate deputy physician-in-chief of MSK’s Regional Care Network
- Weill Cornell Medicine awarded $9 million grant for mantle cell lymphoma research
- UPenn’s Abramson Cancer Center joins NCCN as member institution
- New CPRIT Scholar Grants recruit talent to Texas institutions
- Huntsman Cancer Institute breaks ground for Utah’s first proton therapy center
- David Kerstein named chief medical officer of Anchiano Therapeutics
Clinical Roundup
- Brain cancer immunotherapy SurVaxM extends survival
- Avelumab in platinum-resistant/refractory ovarian cancer did not meet OS and PFS endpoints
Drugs & Targets
- FDA grants Venclextra accelerated approval for newly-diagnosed AML
- FDA approves Daurismo for newly-diagnosed AML in adults 75 years and older
- FDA approves gilteritinib for relapsed or refractory AML with a FLT3 mutation
- FDA approves Truxima as biosimilar to Rituxan for non-Hodgkin’s lymphoma