Jordyn Sava is an editor for Targeted Oncology.
The FDA’s Oncologic Drugs Advisory Committee discussed the potential need for interpreting pharmacology data, using trial designs that compare multiple dosages, and safety and tolerability assessments to help determine the optimal doses of oncology drugs for pediatric patients.
Glofitimab is the first and only CD20xCD3 T-cell engaging bispecific antibody approved for the treatment of relapsed/refractory DLBCL.
Data from the phase 3 NAPOLI 3 trial have led the FDA to accept a supplemental new drug application for NALIRIFOX in patients with metastatic pancreatic ductal adenocarcinoma
In an interview with Targeted Oncology, Se-Hoon Lee, MD, PhD, discussed long-term follow-up data from the CHRYSALIS trial in patients with EGFR-mutated advanced non–small cell lung cancer.
A newly authorized phase 1b study will evaluate the safety and efficacy of the continuous delivery of lenalidomide among patients with multiple myeloma.
The phase 2a portion of a study will evaluate fostrox as a triplet in earlier lines of immunotherapy combinations for patients with hepatocellular carcinoma.
The FDA has requested additional time to assess the analyses of previously submitted data from the phase 3 DeFi trial of nirogacestat in desmoid tumors, leading to an extension of the Prescription Drug User Fee Act decision date.
In part C of the phase 2 SGN35-027 trial evaluating brentuximab vedotin, nivolumab, doxorubicin, and dacarbazine in patients with classical Hodgkin lymphoma, fewer than half of patients developed primarily low-grade peripheral neuropathy, and no cases of febrile neutropenia were observed.
Promising data were revealed with nelarabine, intensive L-asparaginase, and protracted intrathecal therapy among patients aged 25 years and younger with T-cell acute lymphoblastic leukemia.
Data from the phase 3 CAPItello-291 trial of capivasertib plus fulvestrant in HR-positive, HER2-negative locally advanced or metastatic breast cancer have led the FDA to grant priority review to the new drug application for the combination.
In an interview with Targeted Oncology, Jonathan C. Trent, MD, PhD, discussed primary and offshoot analysis data from the INTRIGUE study of patients with GIST.
The Association for Clinical Oncology has provided recommendations to the FDA for its draft guidance, which reflects a strong preference for randomized controlled trials.
The FoundationOne®Liquid CDx has received FDA approval as a companion diagnostic for encorafenib plus cetuximab for patients with BRAF V600E-mutated metastatic colorectal cancer.
Treatment with INT230-6 alone led to extended survival among patients with soft tissue sarcoma by nearly 450 days, compared with synthetic controls, and demonstrated a favorable safety profile.
Now that the FDA has lifted the partial clinical hold on the phase 1 study of FHD-286 in patients with relapsed/refractory acute myelogenous leukemia and myelodysplastic syndrome, there are plans to initiate a trial to further assess the agent with decitabine or cytarabine.
In an interview with Targeted Oncology, Joshua K. Sabari, MD, discussed drug shortages and how they are affecting clinicians and patients in the oncology space.
In an interview with Targeted Oncology, Narissa Nonzee, PhD, discussed a study which focused on increasing colorectal screening rates among patients in ethnic minority communities.
In an interview with Targeted Oncology, Hatem Soliman, MD, provides an overview on testing for HER2-positive breast cancer and the available therapies in the first-, second-, and third-line settings.
Findings from the phase 3 PROpel have led to the FDA approval of olaparib in combination with abiraterone and prednisone or prednisolone for a prostate cancer subgroup.
The biologics license application for lifileucel has been accepted by the FDA for patients with advanced melanoma based on positive data from the C-144-01 clinical trial.
A study looking at mortality rates from major cancer types may help inform cancer prevention and treatment strategies, and lead to a reduction to the global cancer disparities seen today.
With sitravatinib plus nivolumab, the primary end point of overall survival was not met in the phase 3 SAPPHIRE study in patients with advanced nonsquamous non-small cell lung cancer.
If granted approval, fruquintinib will be the first and only highly selective inhibitor of all 3 VEGF receptors to be approved in the United States for patients with metastatic colorectal cancer.
In an interview with Targeted Oncology, Andreas Varkaris, MD, PhD, discussed findings from the ReDiscover trial and treating patients with PIK3CA mutations.
When used as a monotherapy or in combination with venetoclax, voruciclib was generally well tolerated and showed an encouraging preliminary efficacy signal in patients with acute myeloid leukemia or B-cell malignancies.
Ropeginterferon alfa-2b-njft was added to the NCCN guidelines and granted category 2A status for the treatment of polycythemia vera.
Bill 1196 / Assembly Bill 1673 aims to improve access to precision medicine for patients with cancer in New York by requiring all state-regulated health plans to cover biomarker testing when it is supported by medical and scientific evidence.
In an interview with Targeted Oncology, Pedro Barata, MD, MSc, discussed the current therapies available, unmet needs, and ongoing studies for patients with metastatic prostate cancer.
Mitazalimab has received an orphan drug designation from the FDA and is currently being investigated in the OPTIMIZE-1 trial in combination with modified FOLFIRINOX for the treatment of patients with pancreatic cancer.
The FDA has approved avapritinib for adult patients with indolent systemic mastocytosis based on findings from the phase 2 PIONEER trial.