The OncFive: Top Oncology Articles for the Week of 7/12

Welcome to OncLive®’s OncFive!
Every week, we bring you a quick roundup of the 5 top stories from the world of oncology—ranging from pivotal regulatory decisions to key pipeline updates to expert insights on breakthroughs that are moving the needle in cancer care. This resource is designed to keep you informed on the latest updates in the space, in just a matter of minutes.
Here’s what you may have missed this week:

FDA Approves Gedatolisib Plus Fulvestrant ± Palbociclib for Hormone Receptor–Positive, HER2-Negative, Locally Advanced/Metastatic Breast Cancer

The FDA has approved gedatolisib (Revtorpyk), a multitarget phosphoinositide 3-kinase (PI3K)/AKT/mechanistic target of rapamycin (mTOR) inhibitor, plus fulvestrant (Faslodex), with or without palbociclib (Ibrance), for adult patients with hormone receptor–positive, HER2-negative advanced breast cancer without a PIK3CA mutation following progression on 1 or more lines of endocrine therapy in the metastatic setting. The decision was supported by the PIK3CA wild-type cohort of the phase 3 VIKTORIA-1 trial (NCT05501886), in which gedatolisib plus fulvestrant and palbociclib (n = 131) achieved a median progression-free survival (PFS) of 9.3 months (95% CI, 7.2-16.6) vs 2.0 months (95% CI, 1.8-2.3) with fulvestrant alone (n = 131; adjusted hazard ratio [HR], 0.24; 95% CI, 0.17-0.35; P < .0001). Gedatolisib plus fulvestrant without palbociclib (n = 130) resulted in a median PFS of 7.4 months (95% CI, 5.5-9.9; HR, 0.33; 95% CI, 0.24-0.48; P < .0001), with overall response rates (ORRs) of 32%, 28%, and 1% across the triplet, doublet, and fulvestrant-alone arms, respectively. The most common any-grade adverse effects (AEs) with the triplet included stomatitis (69.2%), neutropenia (65.4%), and nausea (43.8%). Overall survival (OS) data remained immature, with neither gedatolisib arm reaching statistical significance for OS at the data cutoff date of May 30, 2025. The gedatolisib new drug application (NDA) was submitted under the FDA’s Real-Time Oncology Review program.

FDA Awards Traditional Approval to Selpercatinib for RET+ Advanced Solid Tumors

The FDA has granted traditional approval to selpercatinib (Retevmo), a RET kinase inhibitor, for adult and pediatric patients 2 years of age and older with locally advanced or metastatic solid tumors harboring a RET gene fusion that have progressed on or after previous systemic treatment or who have no satisfactory alternative treatment options. The decision converted the September 2022 accelerated approval in this tumor-agnostic indication; it was supported by data from the phase 1/2 LIBRETTO-001 (NCT03157128) and LIBRETTO-121 (NCT03899792) trials, along with data on its use in RET fusion–positive non–small cell lung cancer (NSCLC) and thyroid cancer. In LIBRETTO-001, patients with RET fusion–positive tumors other than NSCLC and thyroid cancer (n = 75) achieved an ORR of 47% (95% CI, 35%-59%) and a median duration of response (DOR) of 24.5 months (95% CI, 11.2-49.1). The prescribing information includes warnings and precautions for hepatotoxicity, interstitial lung disease/pneumonitis, hypertension, prolonged QT interval, hemorrhagic AEs, and slipped capital femoral epiphysis in pediatric patients. Selpercatinib is dosed at 120 mg or 160 mg twice daily for patients 12 years and older based on body weight, with body surface area–based dosing for patients 2 to less than 12 years of age.

FDA Issues Third CRL for Rivoceranib Plus Camrelizumab in First-Line HCC Over Additional Manufacturing Concerns

The FDA has issued a complete response letter (CRL) to the NDA for rivoceranib plus camrelizumab (SHR-1210) as first-line treatment for unresectable or metastatic hepatocellular carcinoma (HCC), marking the third rejection of the combination for this indication, with the deficiencies tied to a current Good Manufacturing Practice inspection of a manufacturing site rather than any new clinical efficacy or safety concerns. The NDA was supported by the pivotal phase 3 CARES-310 trial (NCT03764293; n = 543), in which final OS results published in The Lancet Oncology showed a median OS of 23.8 months (95% CI, 20.6-27.2) with rivoceranib plus camrelizumab vs 15.2 months (95% CI, 13.2-18.5) with sorafenib (Nexavar; HR, 0.64; 95% CI, 0.52-0.79; P < .0001) . The median PFS was also significantly prolonged with the combination at 5.6 months (95% CI, 5.5-7.4) vs 3.7 months (95% CI, 3.1-3.7; HR, 0.54; 95% CI, 0.44-0.67; P < .0001). The most common grade 3 or higher treatment-related adverse effects in the combination arm included hypertension (38.2%), increased aspartate aminotransferase (17.3%), and increased alanine aminotransferase (14.0%). The combination is already approved in China as a first-line HCC treatment (marketed as Aitan since January 2023) and is included in the 2025 Barcelona Clinic Liver Cancer and European Society for Medical Oncology treatment guidelines; Elevar Therapeutics intends to engage with the FDA to resolve the manufacturing deficiencies.

FDA Accepts NDA for Mezigdomide Plus Kd in R/R Myeloma

The FDA has accepted an NDA for mezigdomide (CC-92480), an oral cereblon E3 ligase modulator, in combination with carfilzomib (Kyprolis) and dexamethasone (MeziKd), for patients with relapsed or refractory multiple myeloma. A Prescription Drug User Fee Act target action date has been set to May 13, 2027. The application was supported by the phase 3 SUCCESSOR-2 trial (NCT05552976), in which data presented at the 2026 ASCO Annual Meeting showed MeziKd (n = 288) led to a median PFS of 18.0 months vs 8.3 months with Kd alone (n = 191), translating to a 52% reduction in the risk of disease progression or death (HR, 0.48; 95% CI, 0.36-0.63; P < .0001). MeziKd elicited an ORR of 80.2% vs 53.4% with Kd, including a complete response or better rate of 26.7% vs 8.9%. The PFS benefit was consistent across all prespecified subgroups regardless of age, cytogenetic risk, refractory status, or extramedullary disease. Grade 3/4 treatment-emergent adverse effects (TEAEs) occurred in 83.7% of MeziKd-treated patients vs 56.5% with Kd, with neutropenia the most common (grade 3/4, 61.1%). Grade 5 TEAEs occurred in 7.3% vs 4.3% of patients, the majority in the context of myeloma progression.

FDA Grants Fast Track Designation to SOT109 in Advanced Colorectal Cancer

The FDA has granted fast track designation to SOT109, an investigational antibody-drug conjugate (ADC) targeting cadherin 17 (CDH17), for patients with advanced unresectable or metastatic colorectal cancer (CRC) who have exhausted standard therapeutic options. CDH17 is expressed in more than 90% of CRC cases and broadly across gastrointestinal malignancies but shows limited expression in healthy tissues, making it an attractive target for ADC-based therapy. SOTIO Biotech expects to initiate a first-in-human, international, open-label phase 1/2 trial (NCT07693751) in the third quarter of 2026, examining the safety, pharmacokinetics, and preliminary efficacy of intravenous SOT109 administered once every 21 days in patients with an Eastern Cooperative Oncology Group performance status of 0 or 1 who have progressed on standard systemic therapies. The trial’s dose-escalation portion (part A) will determine the maximum tolerated and recommended phase 2 doses, and the dose-optimization portion (part B) will assess the optimal dose, objective response rate, and DOR per RECIST 1.1 criteria. Fast track designation may support eligibility for accelerated approval and priority review, subject to applicable criteria, underscoring the unmet need for new targeted options in treatment-refractory advanced CRC.