FDA Fast Tracks Treatment for Select Stage IIB to IV Malignant Melanoma
Source: Pharmacy Times, September 2022
KIN-2787 is a potential treatment for BRAF class II or III alteration-positive and/or NRAS mutation-positive, metastatic or unresectable, stage IIB to IV malignant melanoma.
The FDA has awarded fast track designation to KIN-2787 as a potential treatment for patients with BRAF class II or III alteration-positive and/or NRAS mutation-positive, metastatic or unresectable, stage IIB to IV malignant melanoma.1 The drug has previously been granted FDA orphan drug designation for patients with stage IIB-IV melanoma.
A phase 1 trial (NCT04913285) is analyzing the tolerability, safety, pharmacokinetics, and efficacy of the novel treatment in adults with BRAF-mutated, advanced or metastatic solid tumors (n = 155).