Rasonque's Broad Label Is Built on Survival, Not Response
The FDA's 321-page review of Rasonque documents the survival win that earned a broad pancreatic cancer label, and the mutation subgroups whose response data ran against the drug.
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The Quiet Race to Shut Down Cancer’s Toughest Mutation
KRAS sat on the undruggable list for decades. Silexion's SIL204 is built to silence the mutation earlier in the cell, and the Phase 2/3 program is now moving into patients.
FDA Will Review the First In Vivo CRISPR Therapy Without a Public Panel
Intellia's lonvo-z is on a priority-review track to March 10, 2027 with no advisory committee planned. The one-dose gene edit cut HAE attacks 87% in Phase 3, and the debate over permanence, competition, and price will happen largely out of view.
Celcuity Ships Its First Drug Into the Corner of Breast Cancer No PI3K Label Covered
Celcuity's REVTORPYK became commercially available September 30, claiming the PIK3CA wild-type corner of second-line HR-positive breast cancer no approved PI3K or AKT label covers. The launch must now overcome an immature survival read, heavy stomatitis, and a weekly IV schedule.