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FDA Approves Update to Gilteritinib AML Label to Include OS Data
May 30th 2019A supplemental new drug application has been approved by the FDA to update the label for gilteritinib (Xospata) to include final analysis data from the phase III ADMIRAL trial, which demonstrated an improvement in overall survival with the FLT3 inhibitor compared with salvage chemotherapy in adult patients with relapsed/refractory <em>FLT3</em>-mutant AML.
ARV-110 Granted Fast Track Designation From FDA for mCRPC
May 30th 2019ARV-110, a PROTAC<sup>®</sup> protein degrader, has received a fast track designation from the FDA for the treatment of patients with metastatic castration-resistant prostate cancer who have disease progression following ≥2 systemic therapies.
Anti-PD-L1 Therapy May Have Benefit in Aggressive Papillary Thyroid Cancer
May 29th 2019Patients with aggressive papillary thyroid cancer may be good candidates for treatment with anti–PD-(L)1 immunotherapy due to elevated levels of serum PD-L1, according to findings from a new study presented during the 2019 AACR-AHNS Head and Neck Cancer Conference.
FDA Grants Fast Track Designation to Lasofoxifene for ER+, ESR1-Mutant Metastatic Breast Cancer
May 29th 2019The FDA has granted a fast track designation to the investigational agent lasofoxifene for the treatment of women with estrogen receptor-positive, HER2-negative metastatic breast cancer who have an ESR1 mutation. The agent is currently being investigated in a phase II trial in this setting.
Lenalidomide/Rituximab Receives FDA Approval for Indolent Non-Hodgkin Lymphoma
May 28th 2019The R<sup>2</sup> regimen of lenalidomide (Revlimid) plus rituximab (Rituxan) has been approved by the FDA for the treatment of patients with previously treated follicular lymphoma and marginal zone lymphoma, based on findings from the phase III AUGMENT trial.
Dostarlimab Effective in Endometrial Cancer Regardless of MSI Status
May 28th 2019Dostarlimab (TSR-042), an investigational anti–PD-1 therapy, demonstrated durable responses across subgroups of patients with microsatellite instability–high and microsatellite stable advanced or recurrent endometrial cancer, according to results from the phase I/II GARNET study.
Alpelisib Receives FDA Approval in Breast Cancer
May 24th 2019Based on data from the phase III SOLAR-1 trial, alpelisib (Piqray) has been approved by the FDA for the treatment of postmenopausal women, and men, with HR-positive, HER2-negative, PIK3CA-mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen.
Sorafenib Plus Chemo Combo Shows Benefit in Advanced HCC, But Phase III Trial Not Warranted
May 24th 2019The combination of sorafenib plus gemcitabine and oxaliplatin demonstrated “moderate” benefits compared with sorafenib monotherapy in patients with advanced hepatocellular carcinoma, according to findings from an open-label phase II trial recently published in the <em>British Journal of Cancer.</em>
Komrokji Reviews the Advantages of JAK2 Inhibitors in a Case Study of a Patient With Myelofibrosis
May 24th 2019Rami S. Komrokji, MD, explains the diagnostic and molecular workup behind myeloproliferative neoplasm diagnoses and discusses treatment options based on the case scenario of a patient with myelofibrosis.
FDA Grants Novel TIL Therapy Breakthrough Therapy Designation for Advanced Cervical Cancer
May 24th 2019The FDA has granted a breakthrough therapy designation to novel tumor-infiltrating lymphocyte therapy LN-145 for the treatment of patients with recurrent, metastatic, or persistent cervical cancer who have progressed on or after chemotherapy.
NovoTTF-100L Plus Chemotherapy Approved by FDA for Malignant Pleural Mesothelioma
May 24th 2019The NovoTTF-100L System has received approval from the FDA in combination with pemetrexed and platinum-based chemotherapy as a frontline treatment for patients with unresectable, locally advanced or metastatic malignant pleural mesothelioma.
Examining the Link Between High-Risk Mutations and Transplant Outcomes in Myelofibrosis
May 23rd 2019Raajit K. Rampal, MD, PhD, discusses a retrospective analysis of pre-transplant samples from patients with MF to determine the value of mutational profiling in predicting outcomes after transplant.
Overall Survival, Response Rate Improved With Triplet Regimen in BRAF-Mutant CRC
May 23rd 2019The combination of encorafenib, binimetinib, and cetuximab reduced the risk of death by 48% in patients wtih <em>BRAF</em> V600E-mutant metastatic colorectal cancer who have received up to 2 prior lines of therapy compared with cetuximab and irinotecan-containing regimens, according to the phase III BEACON CRC trial, which met both its primary endpoints.
Socinski Details Immunotherapy Trials for the Treatment of Advanced Nonsquamous NSCLC
May 22nd 2019Mark Socinski, MD, explained to a group of physicians at a recent <em>Targeted Oncology </em>live case-based peer perspectives presentation the treatment considerations and decisions he makes when seeing patients with non–small cell lung cancer in the clinic.
Kasi Highlights Potential Impact of Detecting Resistance Mechanisms With Liquid Biopsies
May 22nd 2019Pashtoon M. Kasi, MD, MBBS, MS, discussed the current role of liquid biopsies in patients with CRC, GI, and other types of cancers. He also highlights the advantages to making treatment decisions based on results from liquid biopsies.
AACR Meeting Focuses on Advances in Immunotherapy Across Several Cancer Types
May 22nd 2019Robert L. Ferris, MD, PhD, co-physician editor-in-chief of <em>Targeted Therapies in Oncology</em>, highlights a series of exciting results presented across various topics, which affect cancer research and treatment, during the 2019 AACR Annual Meeting.
PD-1 Inhibitor Misses Primary OS Endpoint in Phase III Trial for Metastatic TNBC
May 21st 2019Pembrolizumab monotherapy missed the prespecified primary endpoint of superior overall survival compared to chemotherapy in the phase III KEYNOTE-119 trial, in which the PD-1 inhibitor was being investigated as a second- or third-line treatment for patients with metastatic triple-negative breast cancer.
Expert Discusses Role of Genetic Testing in Detection and Prevention of Pancreatic and Other Cancers
May 21st 2019Jennifer Geurts, MS, CGC, discusses the current role of genetic testing, both in patients diagnosed with cancer, as well as family members that could be at risk of developing cancer. She also highlights how genetic counseling can impact treatment decisions in patients with pancreatic, breast, and ovarian cancers.
Stimulatory Effects Observed With Vaccine in Early-Stage CRC
May 20th 2019Investigators on a first-in-human phase I trial found that antibody and T-cell responses were detected in a vaccine targeting GUCY2C, a commonly overexpressed protein in patients with early-stage colorectal cancer.<br />
Small Molecule Demonstrates Activity Against Ibrutinib-Resistant MCL
May 20th 2019Preclinical data suggest that the small molecule IACS-10759, which targets the oxidative phosphorylation and glutaminolysis pathways, may play a critical role in overcoming resistance to ibrutinib in mantle cell lymphoma.
Oxnard Examines Discordance With Liquid Biopsies in Cancer
May 17th 2019Geoffrey R. Oxnard, MD, discusses testing error underlying liquid biopsy discordance. He also highlights steps clinicians can take to optimize liquid biopsies and where he sees this evolving in the treatment landscape for patients with cancer.
Paik Explains the Rationale for the Second-Line Standard for Patients With Squamous NSCLC
May 17th 2019During a recent <em>Targeted Oncology </em>live case-based peer perspectives presentation, Paul K. Paik, MD, explained to a group of physicians the treatment considerations and decisions he makes when seeing a patient with non–small cell lung cancer.
Afatinib Demonstrates Manageable Toxicity, Promising Efficacy in TKI-Naive Patients With EGFR+ NSCLC
May 16th 2019According to results from a phase IIIb interim analysis, afatinib demonstrated a predictable and manageable toxicity profile and promising efficacy in patients with <em>EGFR</em> mutation-positive non–small cell lung cancer.