Eli Lilly’s investigational co-packaged regimen avutometinib plus defactinib (Avmapki/Fakzynja) won FDA approval for adults with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) after prior systemic therapy, marking a rare “novel–novel” combination authorization. The regimen pairs a RAF/MEK-pathway inhibitor with a FAK inhibitor. The FDA’s decision was based on the Phase 2 RAMP-201 trial, where the combination achieved a confirmed overall response rate (ORR) of 44%. The approval is the first specifically for LGSOC, a molecularly distinct ovarian cancer subtype compared with high-grade serous disease. Separately, United Therapeutics’ Tyvaso (treprostinil) secured endpoints in a second Phase 3 idiopathic pulmonary fibrosis (IPF) trial, positioning the company for a potential supplemental NDA and possible priority review. The update follows a prior Phase 3 readout and keeps Tyvaso’s expansion strategy on track toward a potential 2027 commercial launch.