Cabozantinib Granted Breakthrough Therapy Designation for Kidney Cancer
the ONA take:
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to cabozantinib for treatment of advanced renal cell carcinoma (RCC) after a prior therapy administration.
The FDA designation was based on resulting data from METEOR, a phase 3 trial that compared cabozantinib vs everolimus in patients with advanced renal cell carcinoma. Participants all experienced disease progression after treatment with a VEGF receptor tyrosine kinase inhibitor.
Cabozantinib displayed a significant increase in progression-free survival when compared to everolimus treatment in the first 375 randomly chosen participants, with disease progression or death dropping by approximately 42 percent. RCC treatment has historically been limited to cytokine therapy before the more recent use of targeted therapies.
The Breakthrough Therapy Designation is assigned in cases where a drug demonstrates significant benefit and/or life-saving benefits when compared to traditional therapies.
The benefits of the Breakthrough Therapy Designation may include expedited review of a New Drug Application and the involvement of senior FDA managers in the review process.
Cabozantinib, marketed in capsule form under the trade name Cometriq, is currently FDA-approved for the treatment of metastatic medullary thyroid cancer. Cabozantinib inhibits the activity of tyrosine kinases active in oncogenesis, metastasis, and tumor angiogenesis processes.
The FDA has granted Breakthrough Therapy Designation to cabozantinib for treatment of advanced renal cell carcinoma.
- Physical Activity Improves Outcomes for Patients with Breast Cancer and Survivors
- Behavior Pain Assessment Tool Measures Pain In Patients Who Cannot Communicate Verbally
- Whole Genome Sequencing Reveals that 12% of Childhood Cancer Survivors Have Mutations in Genes that Increase Cancer Risk
- Increased 5-Year Survival Rate Seen in NSCLC Subset Treated With Nivolumab
- Novel Test For Multiple Myeloma Uses Microchip, Conventional Blood Sample
- Exercise, Psychological Interventions Better for Cancer Fatigue Than Medications
- ASCO Issues Global Guidance for HPV Vaccination for Cervical Cancer Prevention
- Discharge Events Improved With Standardized Inpatient Palliative Care Consultation
- Little Opposition to Early Palliative Care for Symptom Management in Pediatric Oncology
- Updated ASTRO Guideline Bolsters Safety, Efficacy of Palliative RT for Bone Metastases
- Thyroid Cancer Incidence Increasing Among Younger, Hispanic, African American Populations
- JAK1, JAK2 Inhibition Improves Outcomes in Myeloproliferative Neoplasms, But More Is Needed
- Recommendations Against Contralateral Prophylactic Mastectomy Not Tied to Patient Satisfaction
- Self-efficacy Level Predictive of Likelihood to Follow Through With Colorectal Cancer Screening
- Chronic Myeloproliferative Neoplasms Treatment (Fact Sheet)
Sign Up for Free e-newsletters
Regimen and Drug Listings
GET FULL LISTINGS OF TREATMENT Regimens and Drug INFORMATION
|Head and Neck Cancer||Regimens||Drugs|