News

The FDA has approved the Ventana MMR RxDx Panel, a companion diagnostic test to determine which patients with DNA mismatch repair deficiency are likely to benefit from the anti-PD-1 monotherapy dostarlimab-gxly.

The FDA has granted fast track designation to the highly selective inhibitor of casein kinase 2 inhibitor, silmitasertib for the treatment of patients with recurrent sonic hedgehog-driven medulloblastoma.

Three centers in the United States are recruiting patients with indolent non-Hodgkin lymphoma to receive the investigational selective PI3Kδ inhibitor zandelisib in combination with rituximab in a phase 3 clinical trial setting. The study aims to determine the efficacy and safety of zandelisib in combination with rituximab compared with standard immunochemotherapy.

Thomas Marron, MD, PhD an assistant professor of hematology and medical oncology at Mount Sinai Hospital, discusses the study design and key goals of adding perioperative cemiplimab, an anti-PD-1 antibody, to surgical resection for hepatocellular carcinoma.

The FDA has granted a fast track designation to the folate receptor alpha-targeting antibody-drug conjugate, STRO-002, for the treatment of patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 1 to 3 prior lines of systemic therapy.

The Oncoguard Liver liquid biopsy test has demonstrated a high sensitivity and specificy for the detection of hepatocellular carcinoma (HCC), including in patients with early-stage HCC.

The FDA granted an accelerated approval to dostarlimab-gxly (Jemperli), a programmed cell death receptor-1 blocking antibody, for the treatment of adult patients with mismatch repair-deficient recurrent or advanced solid tumors that have progressed on or following prior treatment and who have no satisfactory alternative treatment options.

Inhibition of the Bruton’s tyrosine kinase (BTK) has shown potency in B-cell malignancies, leading to the exploration of treatment with the BTK inhibitor LOXO-305 in patients with mantle cell lymphoma (MCL) in the phase 3 BRUIN clinical trial.

A 59-year-old Black woman received a diagnosis of clear cell renal cell carcinoma. Chung-Han Lee, Md, PhD and a group of other physicians discussed the patient's case during a Case-Based Roundtable event.

Yael Simons, MD, discusses the study of somatic driver gene alterations in a consecutive series of luminal breast tumors in Black patients, which received an American Society of Clinical Oncology Merit Award.

During a recent tweet chat with Alexander M. Lesokhin, MD, a hematologic oncologist with Memorial Sloan Kettering Cancer Center, joined Targeted Oncology to discuss the case of a 72-year-old White man with newly-diagnosed multiple myeloma.

The FDA has granted a fast-track designation to IN10018, a selective ATP-competitive focal adhesion kinase small molecule inhibitor, for the treatment of platinum-resistant ovarian cancer.

Sintilimab in combination with the chemotherapy agents oxaliplatin and capecitabine improved overall survival in patients with unresectable, locally advanced, recurrent, or metastatic gastric or gastroesophageal junction adenocarcinoma compared with chemotherapy alone, reaching the predefined primary end point of the phase 2 ORIENT-16 clinical trial.

The FDA has issued a complete response letter to Sesen Bio, denying the approval of the Biologics License Application for Vicinium for the treatment of BCG-unresponsive non-muscle invasive bladder cancer.

In an interview with Targeted Oncology™, Shannon N. Westin, MD, MPH, FACOG, discussed the need for the DUO-E trial in the endometrial cancer space and the unique patient population the study will evaluate.

Shannon Westin, MD, MPH, FACOG, a gynecologic oncologist at The University of Texas MD Anderson Cancer Center, discusses the use of durvalumab with or without olaparib for the treatment of endometrial cancers.

The first patient has been dosed in a phase 1b/2 trial of AVB-500, a therapeutic recombinant fusion protein, in combination with gemcitabine and nab-paclitaxel for the treatment of advanced pancreatic adenocarcinoma.

The FDA has approved belzutifan for the treatment of Von-Hippel Lindau-associated renal cell carcinoma treated in frontline setting.

Above-average rates of polycythemia vera have been reported for over a decade due to causes unknown to experts. Intriguing new developments in the ongoing research of the genetic, toxicological, and environmental factors related to these cases have created reason to believe that this issue is not a thing of the past.

Ghasson K. Abou-Alfa, MD, discusses that phase 2 study of tislelizumab as treatment of patients with unresectable hepatocellular carcinoma.

In an interview with Targeted Oncology, Thierry Alcindor, MD, discusses the benefits of adding avelumab to perioperative chemotherapy for the treatment of gastroesophageal cancer in greater detail.

The FDA has granted breakthrough therapy designation to toripalimab in combination with gemcitabine and cisplatin for the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma.

Haris Ali, MD, discussed the diagnosis and treatment of myelofibrosis with a group of physicians during a Targeted OncologyTCase-Based Roundtable event.

The FDA has granted a fast track designation to ALLO-605, a next-generation allogeneic CAR T-cell therapy for the treatment of relapsed or refractory multiple myeloma.

The first patient with marginal zone lymphoma has been dosed in the global phase 2 TIDAL study of zandelisib, a phosphatidylinositol 3-kinase (PI3K) delta inhibitor, for the treatment of MZL and follicular lymphoma in patients who have received at least 2 or more prior therapies.

Combination treatment with the universal cancer vaccine, UV1, and the immune checkpoint inhibitor, pembrolizumab showed strong signals of clinical response in patients with metastatic melanoma while also meeting its key safety/tolerability end point.

Scott Kopetz, MD, PhD, FACP, explains the purpose of the phase 1b KISIMA-01 study of the ATP128 vaccine used with or without with or without ezabenlimab to treat patients with advanced colorectal cancer.

The FDA has granted approval to the combination of pembrolizumab (Keytruda) and lenvatinib (Lenvima) for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

Tycel Jovelle Phillips, MD, discusses the safety and efficacy of venetoclax, lenalidomide, and rituximab in patients with newly diagnosed mantle cell lymphoma

Progression-free survival was significantly prolonged with cabozantinib as treatment of patients with radioiodine-refractory differentiated thyroid cancer in the phase 3 COSMIC-311 clinical trial, showing potential as a new treatment option and leading to the filing of a application for FDA approval.