Verastem combination wins breakthrough status

The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for Verastem’s (Nasdaq: VSTM) investigational RAF/MEK inhibitor VS-6766, combined with defactinib, its FAK inhibitor, in recurrent low-grade serous ovarian cancer (LGSOC) regardless of KRAS status after one or more prior lines of therapy, including platinum-based chemotherapy.

Shares in Verastem closed up by nearly 25% on Monday following the news of the FDA designation.

This combination is being evaluated in the ongoing investigator-initiated Phase I/II FRAME trial.