FDA BRIEF: Week of April 25, 2016


FDA approved


CABOMETYX  (Cabozantinib)

Exelixis Inc.,  South San Francisco, California, USA

INDICATION:  Treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy

REG PATHWAY: Breakthrough Therapy Designation, Fast Track, and Priority Review; approved prior to the Priority Review deadline of June 22, 2016

MECHANISM OF ACTION: Inhibits the tyrosine kinase activity of receptors involved in both normal cellular function and pathologic processes such as oncogenesis, metastasis, tumor angiogenesis, drug resistance, and maintenance of the tumor microenvironment.


  • Single pivotal, randomized (1:1, (N=658)), open-label, multicenter study, CABOMETYX vs. everolimus, in patients with advanced RCC woith 1 prior therapy
  • Primary outcome: Progression-free survival (PFS) : 7.4 mo. vs. 3.8 mo. (p<0.0001)
  • Overall Survival  : 21.4 mo. vs. 16.5 mo. (p<0.0001)



  • Most common serious adverse events: Abdominal pain, pleural effusion, diarrhea, nausea
  • Most common adverse reactions: Diarrhea, fatigue, nausea, decreased appetite, palmar-plantar erythrodysesthesia syndrome, hypertension, vomiting, weight decreased, constipation


Advanced Cooling Therapy, Inc., Chicago, Illinois, USA

INDICATION: Thermal regulating device, intended to:

  • connect to a Gaymar Medi-Therm III Conductive Hyper/Hypothermia System to control patient temperature
  • provide gastric decompression and suctioning

REG PATHWAY: De Novo, Class II


  • Silicone tube with three lumens that is placed in the esophagus
  • Control’s patient’s temperature, while simultaneously maintaining access to the stomach to allow gastric decompression and drainage
  • Modulation and control of patient temperature achieved by connecting to  external heat exchanger and circulating temperature controlled fluid


  • 16 patients, from centers outside US where device is approved
  • Data summaries of therapeutic cooling, maintenance of target temperature, eventual rewarming
  •  Cooled and eventually rewarmed patients resuscitated from cardiac arrest
  • Duration of temperature management: 24-36 hrs
  • No evaluation whether hypothermia improved cardiac arrest outcomes



Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s