Biopharmaceutical firm Exelixis has received breakthrough therapy designation from the US Food and Drug Administration (FDA) for its cabozantinib to treat patients with advanced renal cell carcinoma (RCC) who have received one prior therapy.
Cabozantinib is said to suppress the activity of tyrosine kinases, including MET, VEGF receptors, AXL and RET.
Tyrosine kinases participate in normal cellular function, as well as pathologic processes such as oncogenesis, metastasis, tumour angiogenesis, and maintenance of the tumour microenvironment.
Exelixis president and CEO Dr Michael Morrissey said: “Following the positive top-line results announced in July and a productive dialogue with the FDA, Exelixis believes we can expedite our regulatory timelines and complete the cabozantinib NDA submission in advanced RCC prior to the end of 2015.
“We look forward to working closely with the FDA during the submission and review process, keeping in mind our ultimate goal of bringing a new therapeutic option to the renal cell carcinoma community as soon as possible.”
The approval was based on the results of phase three pivotal trial Meteor that compared cabozantinib to everolimus in patients with RCC who experienced disease progression following treatment with a VEGF receptor tyrosine kinase inhibitor (TKI).
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According to the firm, the trial reached its primary endpoint, showing a statistically significant increase in progression-free survival (PFS) for cabozantinib as compared to everolimus in the first 375 patients randomised as determined by an independent radiology review committee.
Currently, Cabozantinib is marketed in capsule form under the brand name Cometriq in the US to treat progressive, metastatic medullary thyroid cancer (MTC), while in the European Union to treat adult patients with progressive, unresectable locally advanced or metastatic MTC.
Exelixis also discovered another compound cobimetinib, which is being assessed by Roche and Genentech in a broad development programme under the collaboration.
Image: High magnification micrograph of a clear cell renal cell carcinoma. Photo: courtesy of Nephron.