Sabrina Serani

3 days ago | targetedonc.com | Sabrina Serani

The FDA has granted priority review to the supplemental new drug application (sNDA) of revumenib (Revuforj), an oral, first-in-class Menin inhibitor, for the treatment of relapsed or refractory (R/R) NPM1-mutant (mNPM1) acute myeloid leukemia (AML).1This decision underscores the urgent need for novel therapeutic options in this aggressive form of leukemia, which is characterized by high rates of relapse and poor prognosis.

3 days ago | targetedonc.com | Sabrina Serani

The FDA has expanded the label for gallium Ga-68 gozetotide (Illuccix) to include patient selection for radioligand therapy (RLT) in the pretaxane setting for metastatic castration-resistant prostate cancer (mCRPC). This approval allows for earlier identification of patients eligible for prostate specific membrane antigen (PSMA)-directed therapies like lutetium Lu-177 vipivotide tetraxetan (Pluvicto), aligning with a shift towards personalized treatment earlier in the disease course.

4 days ago | targetedonc.com | Sabrina Serani

Findings from the investigator-initiated, noncomparative randomized phase 2 NEO-MEL-T study (NCT04139902) indicate a significant benefit in major pathologic response (MPR) with the addition of a T-cell immunoglobulin and mucin-domain containing-3 (TIM-3) inhibitor, cobolimab, to PD-1 monotherapy in high-risk resectable melanoma.1 The study, presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting by Meghan Mooradian, MD, medical oncologist at Massachusetts General...

4 days ago | targetedonc.com | Sabrina Serani

Final data from the phase 2 PICCOLO trial (NCT05041257) demonstrated substantial efficacy in patients with folate receptor alpha (FRα)-positive recurrent platinum-sensitive ovarian cancer (PSOC) treated with mirvetuximab soravtansine-gynx (Elahere), regardless of homologous recombination deficiency (HRD) status).1 These data, presented at the 2025 ESMO Gynecological Cancers Annual Congress, showed that at a median follow-up of 26.6 months, median progression-free survival (PFS) was 6.9 months...

5 days ago | targetedonc.com | Sabrina Serani

Promising new data from the phase 3 STELLAR-303 pivotal trial (NCT05425940) indicate that zanzalintinib (XL092) in combination with atezolizumab (Tecentriq) significantly improved overall survival (OS) compared with regorafenib (Stivarga) in patients with previously treated metastatic colorectal cancer (CRC).1 This marks a critical advancement in the clinical development program for zanzalintinib, an investigational tyrosine kinase inhibitor (TKI) designed to target various receptor tyrosine...