
A phase 3 study with the goal of demonstrating overall survival benefit with imetelstat versus best available therapy in patients with refractory myelofibrosis has dosed the first patient with the experimental agent.
Sara Karlovitch is an associate editor with Targeted Oncology. She received a duel degree in Journalism and Government and Politics from the University of Maryland.

A phase 3 study with the goal of demonstrating overall survival benefit with imetelstat versus best available therapy in patients with refractory myelofibrosis has dosed the first patient with the experimental agent.

In an interview with Targeted Oncology, Srdan Verstovsek, MD, PhD, discussed the impact of ruxolitinib on MF and other issues facing the patient population.

GTB-3550 TriKE had demonstrated early clinical promise as a monotherapy for the treatment of high-risk myelodysplastic syndromes and refractory/relapsed acute myeloid leukemia.

The FDA has authorized the marking of GI Genius, the first device that uses artificial intelligence to assist in the diagnosis of colon cancer.

The FDA has granted orphan drug designation to CYNK-001, a non-genetically modified cryopreserved human placental hematopoietic stem cell-derived natural killer cell therapy, for the treatment of patients with malignant gliomas.

Telisotuzumab vedotin monotherapy demonstrated a promising objective response rate and has a tolerable safety profile in patients with previously treated c-Met–positive advanced non–small cell lung cancer, according to findings from a phase 2 trial presented in a poster at the American Association for Cancer Research Annual Meeting 2021.

A patient with ovarian cancer has begun treatment with oral endoxifen, an active metabolite of tamoxifen, after a Safe to Proceed Letter was granted by the FDA, according to a press release by Atossa Therapeutics, Inc.

Gedatolisib, a first-in-class PI3K/mTOR inhibitor, plus palbociclib and endocrine therapy demonstrated tolerability and preliminary efficacy in patients with ER+/HER2- advanced or metastatic breast cancer.

Florida Cancer Specialists & Research Institute has appointed a new medical director of the Clinical Research Program, Gustavo Fonseca, MD, FACP.

Both the combination of nivolumab and chemotherapy and nivolumab plus ipilimumab showed a statistically significant and clinically meaningful survival benefit over chemotherapy alone in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma, regardless of PD-L1 expression.

While the treatment of relapsed or refractory Hodgkin lymphoma has seen novel approaches in recent years improving outcomes for many patients, high-risk patients develop progressive disease and have limited treatment options.

The FDA has administered a Breakthrough Device Designation to ProSense, a liquid-nitrogen based cryoablation system that allows for minimally invasive breast cancer treatment, for the treatment of T1 invasive breast cancer and/or patients not suitable for surgical alternative for breast cancer.

In an interview with Targeted Oncology, Axel Grothey, MD, discussed how HER2 has become an actionable target for gastrointestinal cancers and potential HER2-targeted treatments in the field as well as other interesting studies from the role trastuzumab plays in the space.

A supplemental biologics license application for brexucabtagene autoleucel for the treatment of adult patients with relapsed or refractory B-cell precursors acute lymphoblastic leukemia.

The phase 3 ARMADA 2000 trial, which aims to determine the efficacy and safety of devimistat in combination with high-dose cytarabine and mitoxantrone compared to controls for older patients with relapsed or refractory acute myeloid leukemia, has crossed the enrollment of 150 participants.

A New Drug Application has been submitted to the FDA for the combination of plinabulin and granylocyte colony-stimulating factor for the prevention of chemotherapy-induced neutropenia.

The FDA has granted Breakthrough Therapy Designation to futibatinib, a covalently binding FGFR inhibitor for the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma harboring FGFR2 gene rearrangements including gene fusions.

In an interview with Targeted Oncology, Curtis Lachowiez, MD, discussed the findings from the study of venetoclax added to the FLAG-ID regimen for the treatment of patients with secondary or R/R AML.

The FDA has revised the approval of daunorubicin and cytarabine to add 2 new indications for the treatment of newly diagnosed therapy-related acute myeloid leukemia or for AML with myelodysplasia-related changes in pediatric patients aged 1 year and older.

In an interview with Targeted Oncology, John N. Allan, MD, a hematology oncologist at Weill Cornell Medicine, discussed how ibrutinib extends PFS in patients with CLL. He also discussed combination therapy in the future of CLL treatment.

The FDA has issued a complete response letter to Merck’s supplemental Biologics License Application which sought FDA approval of pembrolizumab as treatment of patients with high-risk early-stage triple-negative breast cancer in combination with chemotherapy as neoadjuvant treatment, then as a single agent as adjuvant treatment.

In patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient solid tumors that fail to respond to the standard therapy, the novel anti-PD-1 inhibitor, HLX10, has demonstrated positive efficacy and safety outcomes in a phase 2 clinical trial.

The rolling submission of a Biologics License Application for the combination of ublituximab and umbralisib for the treatment of chronic lymphocytic leukemia has been completed for submission to the FDA.

In an interview with Targeted Oncology, Walter M. Stadler, MD, discussed recent updates and changes in the kidney cancer landscape, including treatment with HIF and VEGFR inhibitors.

The FDA has granted 2 breakthrough device designations to the molecular residual disease test, Signatera.

In an interview with Targeted Oncology, Maria Lia Palomba, MD, a hematologic oncologist at Memorial Sloan Kettering Cancer Center, discussed the efficacy and safety of liso-cel in patients with R/R MCL as observed in the phase 1 TRANSCEND NHL 001 study.

Clinical development of the oral chemotherapy agent, tesetaxel is being discontinued as the treatment of metastatic breast cancer, colorectal cancer, and other solid tumors after the FDA provided feedback on a pre-New Drug Application.

Heinz-Josef Lenz, MD, discusses immunogenic cell death and the results of using irinotecan versus oxaliplatin in an interview with Targeted Oncology.

Melphalan flufenamide has been added to the Multiple Myeloma Clinical Practice Guidelines of the National Comprehensive Cancer Network, for the treatment of adult patients with relapsed or refractory multiple myeloma who have had at least 4 prior lines of therapy.

Tanya B. Dorff, MD, a medical oncologist at the City of Hope Cancer Center, discusses the reasoning behind using PSCA-targeted chimeric antigen receptor T-cell therapy and the design of this early study in an interview with Targeted Oncology.