In the draft guidance, the agency discusses how sponsors can leverage MRD and complete response rates as near-term efficacy measures and speed new therapies to market.
The proceeds may in part fund R&D of its product candidates, which include the pan-RAS molecular glue ERAS-0015 and the KRAS inhibitor ERAS-4001.
The firm will conduct a Phase I trial of its KRAS G12D inhibitor in solid tumors and a Phase II trial of its G12C inhibitor plus an ERK1/2 inhibitor in NSCLC.
Otsuka Pharmaceutical, which licensed the antisense oligonucleotide from Ionis, has rights to commercialize it in Europe and Asia.
The update is based on data from the FLEX study in patients with HR-positive, HER2-negative early-stage breast cancer.
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