Erasca: FDA Grants Fast Track Designation To Naporafenib In Combination With Trametinib

(RTTNews) - Erasca, Inc. (ERAS) announced the FDA has granted Fast Track Designation to naporafenib in combination with trametinib for the treatment of adult patients with unresectable or metastatic melanoma. The company noted that Naporafenib has been dosed in more than 500 patients to date, establishing its safety, tolerability, and preliminary proof-of-concept in multiple indications.

Jonathan Lim, Erasca's CEO, said: "We are now rapidly advancing clinical development of naporafenib in combination with trametinib in the post-IO setting in patients with NRASm melanoma with initiation of our pivotal Phase 3 SEACRAFT-2 trial expected in the first half of 2024."

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