Ilixadencel granted Regenerative Medicine Advanced Therapy by FDA for metastatic kidney cancer

The US Food and Drug Administration (FDA) has designated ilixadencel a Regenerative Medicine Advanced Therapy (RMAT) as a treatment for metastatic renal cell carcinoma (RCC). This designation is similar to the FDA’s Breakthrough Therapy Designation, and recognises the therapeutic potential of ilixadencel as well as the unmet patient need for viable therapies for this difficult-to-treat […]

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Avelumab plus axitinib combination shows promise

A clinical trial looking at the combination of avelumab plus axitinib for renal cell carcinoma (RCC), JAVELIN Renal 101, has released some positive top-line results, which will be presented at an upcoming medical congress. JAVELIN Renal 101 is a pivotal phase III study with 886 renal cancer patients. As part of a planned interim analysis, […]

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Avelumab combination designated a breakthrough therapy by the FDA

The immunotherapy drug avelumab (Bavencio) has been designated a breakthrough therapy by the US Food and Drug Administration (FDA) for the second time, this time for use in combination with axitinib (Inlyta) for people with advanced renal cell carcinoma (RCC) who have received no previous treatment. The breakthrough therapy designation speeds up the development and […]

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