Panitumumab

Minneapolis-based Celcuity Inc. (Nasdaq: CELC) submitted a supplemental New Drug Application (sNDA) to the US FDA for Revtorpyk (gedatolisib), seeking approval in patients with hormone receptor-positive (HR+), HER2-negative, locally advanced or metastatic breast cancer harboring a PIK3CA mutation, following progression on at least one prior line of endocrine therapy. If approved, the filing would extend Revtorpyk's label to cover both PIK3CA-mutant and wild-type disease, encompassing the full HR+/HER2- advanced breast cancer population in the second-line setting. The application arrives six weeks after the FDA approved Revtorpyk on July 14, 2026 for the PIK3CA wild-type subset of the same indication. That approval, based on the wild-type cohort of the Phase III VIKTORIA-1 trial, established Revtorpyk as the first pan-PI3K and mTORC1/2 inhibitor to receive FDA clearance. The current sNDA is supported by the PIK3CA-mutant cohort of the same trial, in which gedatolisib was compared directly against alpelisib plus fulvestrant — an established targeted regimen for PIK3CA-mutant disease — rather than against fulvestrant alone. In the 350-patient PIK3CA-mutant cohort of VIKTORIA-1, the Revtorpyk triplet (gedatolisib plus fulvestrant and palbociclib) reduced the risk of disease progression or death by 50% compared with alpelisib plus fulvestrant (HR=0.50; 95% CI: 0.37–0.68; p<0.0001), with median progression-free survival (PFS) of 11.1 months versus 5.6 months. The Revtorpyk doublet (gedatolisib plus fulvestrant) produced a comparable reduction in risk (HR=0.51; 95% CI: 0.33–0.79; descriptive p=0.0013), with median PFS of 11.3 months. Objective response rates were 49% and 36% for the triplet and doublet, respectively, with median durations of response of 15.7 and 24.2 months. The company said the safety profile was consistent with data previously reported from the wild-type cohort. Three targeted treatment options currently hold FDA approval for molecularly selected HR+/HER2- advanced breast cancer populations that include PIK3CA mutations: Novartis's alpelisib (Piqray), AstraZeneca's capivasertib (Truqap), and Roche's inavolisib (Itovebi). Gedatolisib's pan-isoform mechanism — inhibiting all four class I PI3K isoforms alongside mTORC1 and mTORC2 — is designed to eliminate the pathway escape routes that single-node inhibitors may leave open, though no head-to-head data against capivasertib or inavolisib exist. PIK3CA mutations occur in approximately 40% of HR+/HER2- metastatic breast cancers, representing a commercially material subset of the most common breast cancer subtype. Celcuity said it intends to submit the VIKTORIA-1 data to other regulatory authorities following the sNDA submission. Spot something wrong? Report an issue with this article

San Diego-based Erasca, Inc. (Nasdaq: ERAS) announced that the US FDA has granted Fast Track Designation (FTD) to ERAS-0015, an oral pan-RAS molecular glue, for the treatment of metastatic pancreatic adenocarcinoma. The designation, granted August 24, 2026, is the first formal regulatory milestone for the compound anywhere in the world. ERAS-0015 is a molecular glue designed to inhibit signaling across mutant and wild-type RAS proteins by inducing formation of an inhibitory RAS complex, giving it potential activity across multiple RAS-driven tumor genotypes. The FTD follows updated Phase I data from AURORAS-1 reported in July, when ERAS-0015 produced a 57% unconfirmed eight-week ORR among seven evaluable patients with second-line or later KRAS G12X pancreatic ductal adenocarcinoma at the 32 mg recommended dose for expansion. Six of the seven remained on treatment at the May 25 cutoff, with no dose-limiting toxicities reported. The FTD enables more frequent interactions with the FDA and, if applicable criteria are met, potential eligibility for rolling review, accelerated approval, and priority review. Erasca said it plans to use the designation to advance discussions with the agency on a Phase III trial in pancreatic cancer, alongside two additional registration-enabling trials in lung cancer. Revolution Medicines has asserted patent infringement and trade secret misappropriation claims against Erasca relating to ERAS-0015, disclosures that contributed to a roughly 48% single-day decline in Erasca's share price in late April 2026 and triggered multiple securities class action complaints. Those proceedings remain ongoing and are unresolved as of the date of this designation. Erasca said it expects to report additional ERAS-0015 monotherapy expansion and combination dose-escalation data, including results from a panitumumab combination cohort in colorectal cancer, in H1 2027. The company has indicated plans to initiate a Phase III trial in first-line PDAC in 2027 and a registration-enabling trial in second-line or later non-small cell lung cancer in H1 2027. Spot something wrong? Report an issue with this article