Caroline Seymour

Revumenib resulted in deep response rates, facilitating subsequent transplant in patients with KMT2A-rearranged or NMP1-mutant, relapsed/refractory acute myeloid leukemia.

The FDA has granted an orphan drug designation to BEA-17 for the treatment of patients with glioblastoma.

A biologics license application seeking the approval of remestemcel-L has been resubmitted to the FDA for the treatment of pediatric patients with steroid-refractory, acute graft-vs-host-disease.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of luspatercept for the treatment of patients with anemia associated with non–transfusion dependent beta thalassemia.

Fam-trastuzumab deruxtecan-nxki has received approval in the European Union as a single agent for the treatment of patients with unresectable or metastatic HER2-low breast cancer who have received prior chemotherapy for metastatic disease or developed disease recurrence during or within six months of completing adjuvant chemotherapy.

Maintenance therapy with carfilzomib, lenalidomide, and dexamethasone led to a significant improvement in progression-free survival vs lenalidomide alone in patients with newly diagnosed multiple myeloma who underwent autologous stem cell transplant after induction therapy, according to an unplanned interim analysis of the phase 3 ATLAS trial.

Adding the PD-1 inhibitor pembrolizumab to gemcitabine and cisplatin led to a significant improvement in overall survival compared with gemcitabine and cisplatin alone as first-line therapy in patients with advanced or unresectable biliary tract cancer.

Autologous stem cell transplant had no effect on real-world time to next treatment and overall survival compared with maintenance rituximab following induction with bendamustine and rituximab or R-CHOP, for patients with mantle cell lymphoma according to findings from a retrospective study.

The FDA has granted a fast track designation to DB-1303 for the treatment of patients with advanced, recurrent or metastatic endometrial cancer with HER2 overexpression who have progressed on or after standard systemic therapy.

The addition of stereotactic body radiation therapy to sorafenib led to an improvement in overall survival, progression-free survival, and time to disease progression compared with sorafenib alone in patients with locally advanced, hepatocellular carcinoma.

The FDA has granted an orphan drug designation to LNS8801 for the treatment of patients with metastatic cutaneous melanoma.

The FDA has approved zanubrutinib for the treatment of patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.

Olutasidenib has been added to the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology as a recommended targeted therapy for adult patients with relapsed/refractory acute myeloid leukemia with an IDH1 mutation.

The addition of daratumumab to lenalidomide and dexamethasone led to a 27% reduction in the risk of death compared with Rd alone in patients with relapsed/refractory multiple myeloma.

The FDA has granted an orphan drug designation to JBI-802 for the treatment of patients with small cell lung cancer and acute myeloid leukemia.

ADXS-504, an investigational off-the-shelf neoantigen therapy, has been reported to be well tolerated and safe in patients with biochemically recurrent early prostate cancer.

The FDA has granted an orphan drug designation to QN-302 for the treatment of patients with pancreatic cancer.

Treatment with the folate receptor α–directed antibody-drug conjugate luveltamab tazevibulin led to a 37.5% overall response rate in Frα-selected patients with advanced ovarian cancer, defined by a tumor proportion score above 25%.

The FDA has granted an orphan drug designation to azeliragon for the treatment of patients with glioblastoma.

Neoadjuvant treatment with SHR-1701 with or without chemotherapy followed by surgery or radiotherapy induced responses in more than half of patients with stage III unresectable non–small cell lung cancer and increased resectability in those assigned to definitive surgery.

Japan’s Ministry of Health, Labor, and Welfare has approved acalabrutinib for the treatment of previously untreated patients with chronic lymphocytic leukemia and small lymphocytic lymphoma.

Adding mitazalimab to mFOLFIRINOX led to a 52% objective response rate as frontline therapy in 23 patients with metastatic pancreatic cancer.

Abiraterone acetate granules for oral suspension demonstrated therapeutic equivalence and comparable safety to the original formulation of abiraterone acetate in patients with metastatic castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer.

A biologics license application has been submitted to the FDA seeking the approval of cosibelimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or radiation.

The FDA has granted a breakthrough device designation to the OverC Multi-Cancer Detection Blood Test for the early detection of cancers including esophageal, liver, lung, ovarian, and pancreatic in adults aged to 50 to 75 years with average risk.

The European Committee for Medicinal Products for Human Use has announced that it does not support the marketing authorization of omburtamab for the treatment of patients with central nervous system/leptomeningeal metastasis from neuroblastoma.

Treatment with PDS0101 plus the tumor-targeting IL-12 fusion protein M9241 and bintrafusp alfa elicited encouraging overall survival data in patients with checkpoint inhibitor–naïve and –refractory advanced human papillomavirus–positive anal, cervical, head and neck, vaginal, and vulvar cancer.

Treatment with INV-1120 was well tolerated and demonstrated preliminary signals of stable disease as a single agent in patients with advanced solid tumors.

An unshakeable belief in the power of the immune system and a deep-seated desire to make the world a better place have guided Eric J. Small, MD, throughout his career.

LP-284 showed superior antitumor activity compared with LP-184 independent of PTGR1 expression levels in DNA damage repair–deficient mantle cell lymphoma cell lines.