– Exelixis submitted rolling NDA for cabozantinib.
– Exelixis plans to complete the submission in the next two months.
– Positive Results from the METEOR trial with cabozantinib on advanced renal Cell carcinoma led the FDA to grant the drug breakthrough designation.
Based on good results from a Phase 3 from the METEOR pivotal trial, Exelixis (EXEL) initiated submission of its rolling New Drug Application (NDA) to the FDA regarding its cancer targeted product cabozantinib for the treatment of patients with advanced renal cell carcinoma (RCC) who have received one prior therapy.
By the way, in August 2015, which is only a couple of months ago, the FDA granted cabozantinib breakthrough designation. The reason we can think about for this granted designation is that the FDA might have liked whatever it happened to learn about the drug’s results on kidney cancer.
Exelixis has filed the first component of the application for potential approval of cabozantinib in the United States. The rolling NDA allows completed portions of an NDA to be submitted and reviewed by the FDA on an ongoing basis. The good news here is Exelixis announcement that it plans to complete the NDA submission before the end of 2015, which means in just one, or two months.
METEOR, phase 3 pivotal trial compared cabozantinib to everolimus in advanced renal cell carcinoma (RCC) patients who experienced disease progression following treatment with a VEGF receptor tyrosine kinase inhibitor. The announced results showed that the trial had met its primary endpoint of improving progression-free survival (PFS), compared with everolimus, where cabozantinib was associated with a 42% reduction in the risk of disease progression or death.
A new formulated tablet
Cabozantinib is currently marketed in capsule form under the brand name COMETRIQ® in the United States for progressive, metastatic medullary thyroid cancer (MTC), and in the European Union for progressive, unresectable locally advanced or metastatic MTC. Comtriq, however, is not indicated for patients with RCC. In the METEOR trial, and all other cancer trials, Exelixis is investigating a tablet formulation of cabozantinib distinct from the Comtriq capsule form. It is this new tablet formulation of cabozantinib, which is the subject of the NDA for advanced RCC.
Less than a month following the FDA granting Exelixis drug cabozantinib Beakthrough designation, Data from the METEOR trial were presented at the European Cancer Congress and concurrently published in The New England Journal of Medicine. This is good news about a targeted drug that could probably demonstrate its breakthrough nature on other advanced cancers.
Oncologists and patients with advanced RCC recognize how urgent is the need for new treatment treatment options for advanced RCC. That’s why the NDA submission for cabozantinib brings good news to oncologists, hope for patients with advanced RCC and, most probably, good news also to Exelixis and its shareholders..
EXEL is expected to have a series of upcoming good news. We have already posted articles about this subject, in Prohost Letters and in other separate articles.
We are excited about Exelixis’ upcoming news.
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