Oncology Venture - FDA OKs 505(b)(2) pathway for LiPlaCis in mBC

Edison Investment Research - Pharmaceuticals & healthcare - Oncology Venture: Oncology Venture (OV) recently announced that the FDA agreed the 505(b)(2) pathway is an appropriate route for LiPlaCis in metastatic breast cancer (mbC) such that objective response rate (ORR) is a suitable primary endpoint for the study. OV is seeking approval for LiPlaCis via a single-arm pivotal study in ~100-200 patients with mBC. The company plans to update recruitment timelines following FDA approval of the IDE/IND application, which OV expects in H119.

ISIN: DK0060732477

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