FDA Grants Fast Track Designation to KIN-2787 for Select Stage IIB to IV Malignant Melanoma
Source: Onc Live, September 2022
The FDA has granted a fast track designation to KIN-2787 for use as a potential therapeutic option in patients with BRAF class II or III alteration–positive and/or NRAS mutation–positive, metastatic or unresectable, stage IIB to IV malignant melanoma.
Approximately 6% of patients with cancer harbor oncogenic BRAF alterations, which are known to result in activated BRAF monomers (class I), homodimers (class II), and heterodimers (class III).2 Although some BRAF inhibitors have received regulatory approval for use in those with class I BRAF mutation–driven cancers, these agents are not effective in those with class II or III BRAF mutations.
“The interesting thing about [KIN-2787] is that it was developed also to try to target the other 2 classes of BRAF mutations; that was not the case for the drugs that we have available on the market. [Those agents] were always developed to try to target the class I mutation,” Cesar Augusto Perez, MD, director of drug development at Florida Cancer Specialists at Sarah Cannon Research Institute, told OncLive® in a past interview. “It is important that we have been able to classify these mutations and recognize the mechanisms of how they promote proliferation and survival. We can now actually target these mutations. One of the most exciting things is that after we classified and understood how the class II and class III mutations can promote survival, we were able to develop drugs to target [them].”