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.
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