CRLX101 Fast Tracked for Metastatic Renal Cell Carcinoma

Cerulean Pharma announced that the FDA has granted Fast Track designation to CRLX101 in combination with Avastin (bevacizumab) for the treatment of metastatic renal cell carcinoma (mRCC) following progression through two or three prior lines of therapy.

CRLX101 is a tumor-targeted nanoparticle-drug conjugate (NDC) designed to concentrate in tumors and slowly release camptothecin inside tumor cells. CRLX101 inhibits both topoisomerase 1 and hypoxia-inducible factor-1α (HIF-1α).

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CRLX101 has shown activity in four different tumor types, both as monotherapy and in combination with other cancer treatments. Currently CRLX101 is being investigated in combination with Avastin as a treatment of relapsed renal cell carcinoma in a randomized Phase 2 trial.

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