Moxetumomab pasudotox has been granted a priority review by the FDA for the treatment of adult patients with hairy cell leukemia (HCL) who have received at least 2 prior lines of therapy, according to AstraZeneca (MedImmune), the developer of the anti-CD22 recombinant immunotoxin.
A marketing authorization application for olaparib (Lynparza) for the treatment of women with <em>BRCA</em>-mutated, HER2-negative metastatic breast cancer who previously received chemotherapy in the neoadjuvant, adjuvant, or metastatic setting has been accepted by the European Medicines Agency.
A marketing authorization for ABP 980, a biosimilar to trastuzumab (Herceptin), has been issued a positive opinion by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).
The new drug application for larotrectinib (LOXO-101) for treatment of patients with locally advanced or metastatic solid tumors that harbor an NTRK gene fusion has been completed.
According to findings from the phase III MURANO trial recently published in the<em> New England Journal of Medicine, </em>the venetoclax (Venclexta) plus rituximab (Rituxan) regimen lowered the risk of disease progression or death by 83% in comparison with bendamustine (Treanda) plus rituximab (Rituxan) in patients with relapsed or refractory chronic lymphocytic leukemia<em>.</em>
The combinations of atezolizumab and cobimetinib induced a 31% disease control rate in patients with heavily-pretreated metastatic colorectal cancer. Results from a 2-stage phase Ib study presented at the 2018 Gastrointestinal Cancers Symposium demonstrated an overall response rate of 8% (n = 7). All responses were partial responses.
The combination of TTFields and temozolomide has been added by the NCCN to its guidelines for Category 1 treatment for patients with newly diagnosed glioblastoma, following maximal safe resection and completion of radiation therapy.
In a national coverage determination issued March 16, CMS announced that it will cover diagnostic laboratory tests using next-generation sequencing for patients with advanced cancer.
Based on data from the phase III PROSPER trial, a supplemental new drug application for enzalutamide for the treatment of men with nonmetastatic castration-resistant prostate cancer has been granted a priority review by the FDA, according to Pfizer and Astellas, the companies developing the antiandrogen agent.
Tazemetostat showed efficacy in heavily treated patients with relapsed/refractory non-Hodgkin lymphoma in interim results from a phase II trial. Investigators hope that the analysis of a 62-gene panel biomarker performed on the same patient population will help to identify the patients who will have an even stronger response to the oral EZH2 inhibitor developed by Epizyme.
Based on the phase II study BLC2001, erdafitinib has been granted a breakthrough therapy designation by the FDA for the treatment of metastatic urothelial carcinoma, according to Janssen, the manufacturer of the oral pan-FGFR tyrosine kinase inhibitor.
The FDA has placed a clinical hold on a phase I/II study of axalimogene filolisbac and durvalumab, according to an announcement by Advaxis, the manufacturer of axalimogene filolisbac, in a quarterly earnings report.The study is evaluating the combination in patients with advanced, recurrent or refractory HPV-associated cervical cancer and HPV-associated head and neck squamous cell carcinoma.
Pembrolizumab (Keytruda) has been granted a priority review by the FDA for the treatment of advanced cervical cancer with disease progression on or after chemotherapy.
After reviewing data from a decade of clinical research, a joint panel from ASCO and the College of American Pathologists concluded that circulating tumor DNA testing should be used only to screen for participation in, or during, a clinical trial.
23andMe, Inc. has received authorization from the FDA for the first-ever direct-to-consumer genetic test for cancer risk.
In an 8 to 4 vote, the FDA's Oncologic Drugs Advisory Committee recommended approval of blinatumomab for the treatment of minimal residual disease-positive B-cell precursor acute lymphoblastic leukemia.
According to findings published in<em> Nature Communications, </em>a blood test detecting early changes in circulating tumor DNA (ctDNA) may provide earlier indication of whether patients with hormone receptor–positive, HER2-negative breast cancer are responding to the CDK4/6 inhibitor palbociclib (Ibrance).
According to results from the CALGB 8903 study published in the <em>Journal of Clinical Oncology, </em>there is an association between total nut intake and improved outcomes in patients with stage III colon cancer. Results of the study showed patients who ate at least 2 servings of nuts per week had superior disease-free survival and overall survival.
Patients with relapsed/refractory multiple myeloma with renal impairment who were treated with pomalidomide and low-dose dexamethasone had an overall response rate of up to 39%, according to findings of a phase II study published in the <em>Journal of Clinical Oncology.</em>
According to results from a retrospective study published in the <em>Journal of Clinical Oncology, </em>low-coverage genome-wide sequencing of cell-free DNA from plasma is capable of profiling cancer genomes from blood and predicting survival outcomes for patients with metastatic triple-negative breast cancer.
Progression-free survival was successfully predicted by a 23-gene expression-based model for patients with follicular lymphoma enrolled in the phase III randomized PRIMA trial.
Denosumab was recently recommended for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use for the prevention of skeletal-related events in patients with multiple myeloma, according to Amgen, the developer of the RANK ligand inhibitor.
Obese men treated with targeted or immune therapies for metastatic melanoma had a 47% reduced risk of death compared with men who had a normal BMI, according to results from a retrospective multicohort analysis published in <em>The Lancet Oncology.</em><br />
According to findings from the phase III REFLECT trial now published online in the <em>Lancet,</em><sup> </sup>lenvatinib improved progression-free survival and was noninferior for overall survival compared with sorafenib for the frontline treatment of patients with unresectable hepatocellular carcinoma.
In a final analysis of the phase III CALOR trial, the survival benefit demonstrated with adjuvant chemotherapy was sustained in patients with ER-negative breast cancer with isolated locoregional recurrence.
According to phase I findings published in <em>The Lancet Oncology,</em> an objective response rate of 37% was induced in patients with relapsed/refractory lymphoma or chronic lymphocytic leukemia treated with the PI3K-delta inhibitor umbralisib.
The primary endpoint of improving overall survival was not met in the phase III JAVELIN Lung 200 Trial of avelumab in patients with non–small cell lung cancer, according to Merck KGaA and Pfizer, the co-developers of avelumab.
Even as immunotherapy grows more popular as a treatment for solid tumors, physicians are racing to identify patients with the molecular subtypes, rather than the disease, who will derive the most benefit.
According to results of a phase I study recently published in <em>Journal of Clinical Oncology</em>, treatment with the investigational agent DNX-2401 resulted in 20% of patients with recurrent malignant glioma surviving more than 3 years from the time of treatment.
According to recently published results of the international, double-blind randomized phase III 482 Study in <em>The Lancet Oncology, </em><sup> </sup>denosumab was noninferior to zoledronic acid (Zometa) in preventing skeletal-related event in patients with newly diagnosed multiple myeloma.