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Early Findings Show Activity With Neoadjuvant Pembrolizumab Regimen in TNBC
March 1st 2019According to preliminary findings from the phase Ib KEYNOTE-173 trial, combining the PD-1 inhibitor pembrolizumab with platinum/taxane chemotherapy led to high rates of pathologic complete response in patients with locally advanced triple-negative breast cancer.
Targeted Therapies Advancing Thyroid Cancer Treatment Paradigm
March 1st 2019Lori J. Wirth, MD, discusses the current treatment options for patients with advanced thyroid cancers, in addition to some of the trials that are currently enrolling at her center. She also highlights early data that have been presented for targeted therapies in advanced thyroid cancer.
Subcutaneous Trastuzumab Formulation Receives FDA Approval for HER2+ Breast Cancer
February 28th 2019Subcutaneous use of trastuzumab and hyaluronidase-oysk injection has been approved by the FDA in combination with chemotherapy for the treatment of select patients with HER2-positive early breast cancer, in combination with paclitaxel in patients with metastatic HER2-positive breast cancer as a frontline treatment, and alone for patients with metastatic disease who have received at least 1 prior chemotherapy regimen.
Adjuvant Radiation Associated with Worse OS, DSS in Papillary Thyroid Cancer
February 28th 2019Adjuvant external beam radiation therapy was associated with worse overall survival and disease-specific survival in patients with locally invasive papillary thyroid carcinoma, a new retrospective cohort study has found.
Study Confirms Utility of Liquid Biopsies for Biomarker Detection in NSCLC
February 28th 2019Guardant360—a 73-gene next-generation sequencing panel—detected all of the guideline-recommended biomarkers in patients newly diagnosed with metastatic non–small cell lung cancer at a similar rate, but in a faster turnaround time than tissue genotyping, according to data from the NILE study.
Expert Highlights Early Efficacy Seen With Mosunetuzumab in Follicular Lymphoma and DLBCL
February 28th 2019In an interview with <em>Targeted Oncology </em>during the 2018 ASH Annual Meeting, Elizabeth Lihua Budde, MD, PhD, discussed the results seen from this trial for patients with FL and DLBCL. She shared plans for the next steps and how this treatment may impact the patient population.
Fowler Highlights Trials Accruing at MD Anderson for Relapsed/Refractory Follicular Lymphoma
February 28th 2019In an interview with Targeted Oncology, Nathan H. Fowler, MD, discussed the current research for the treatment landscape of relapsed/refractory follicular lymphoma, including 3 clinical trials at MD Anderson that are currently accruing patients with this disease.
Darolutamide Submitted for FDA Approval in Nonmetastatic CRPC
February 27th 2019Based on findings from the phase III ARAMIS trial, a new drug application for darolutamide has been submitted to the FDA seeking the investigational agent's approval as a treatment for patients with nonmetastatic castration-resistant prostate cancer, according to the codevelopers of the investigational agent, Bayer and Orion Corporation.<br />
Expert Highlights Ongoing Research Efforts to Advance Treatment Paradigm in Follicular Lymphoma
February 27th 2019In an interview with <em>Targeted Oncology, </em>Stephen Douglas Smith, MD, discussed recent advancements in FL, new treatments currently being evaluated in clinical trials, and the challenges that still exist within this space.
Expert Highlights Importance of Genetic Testing in Gynecologic Cancers
February 27th 2019According to Huma Q. Rana, MD, genetic testing provides valuable benefit in the treatment landscape of gynecologic cancers. It can inform physicians of the individual and familial risk for developing a malignancy, alert patients of potential screening and preventative measures, and guide selection of potential targeted therapies.
FDA Panel Not in Support of Accelerated Approval of Selinexor in Myeloma
February 27th 2019In an 8 to 5 vote, the FDA's Oncologic Drugs Advisory Committee decided against the accelerated approval of a new drug application for selinexor for the treatment of patients with penta-refractory multiple myeloma. Instead, the committee recommended delaying a decision on the NDA until results are available from the pivotal phase III BOSTON trial.
Frontline Olaparib Succeeds as Maintenance Therapy in BRCA+ Pancreatic Cancer
February 27th 2019AstraZeneca and Merck, the codevelopers of olaparib, have announced that findings from the phase III POLO trial showed use of the PARP inhibitor as a frontline maintenance for patients with germline <em>BRCA</em>-mutated metastatic adenocarcinoma of the pancreas significantly reduced the risk of disease progression or death versus placebo.
Phase III Trial Confirms Subcutaneous Daratumumab Noninferior to Standard in Myeloma
February 26th 2019According to findings from the phase III COLUMBA trial in patients with relapsed/refractory multiple myeloma, a subcutaneous formulation of daratumumab is noninferior in terms of inefficacy and pharmacokinetics to the standard intravenous daratumumab.
Encouraging Findings Seen With Iomab-B as Novel Conditioning for HSCT in AML
February 26th 2019All but 1 of the first 19 patients with relapsed/refractory AML randomized to receive iodine-131 apamistamab had a complete response and went on to have successful engraftment of allogeneic hematopoietic stem cell transplant, according to preliminary results from the ongoing, randomized, phase III SIERRA trial that were presented at the 2019 Transplantation and Cellular Therapy Meetings.
TAS-102 Receives FDA Approval for Gastric/GEJ Cancer
February 25th 2019Based on data from the phase III TAGS trial, TAS-102 has been approved by the FDA as a treatment for adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least 2 prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.
FDA Grants Etoposide Toniribate Orphan Drug Designation for Advanced Biliary Cancer
February 25th 2019The FDA has granted an orphan drug designation to the investigational agent etoposide toniribate for the treatment of patients with relapsed/refractory biliary tract cancer, according to Imbrium Therapeutics, the company developing the topoisomerase II inhibitor.
Adding Ibrutinib to CAR T-Cell Therapy Increases Response Rates in CLL
February 22nd 2019Adding ibrutinib to CAR T-cell therapy led to improved responses in patients with relapsed/refractory chronic lymphocytic leukemia, according to preliminary findings presented at the 2019 Transplantation and Cellular Therapy Meetings.
Encouraging PFS Data Seen With Maintenance Ixazomib in Multiple Myeloma
February 21st 2019In findings from a final PFS analysis of the phase III TOURMALINE-MM3 trial presented during the 2019 Transplantation and Cellular Therapy Meetings, 2-year maintenance therapy with the oral proteasome inhibitor ixazomib following autologous stem cell transplantation improved progression-free survival in patients with multiple myeloma.
Ivosidenib Receives Priority Review From FDA for Frontline IDH1+ AML
February 21st 2019A supplemental new drug application for ivosidenib has been granted a priority review designation by the FDA for the frontline treatment of patients <em>IDH1</em>-mutant acute myeloid leukemia who are ineligible for standard chemotherapy, according to Agios, the manufacturer of ivosidenib.
Pembrolizumab Falls Short in Confirmatory HCC Trial
February 21st 2019Merck, the developer of pembrolizumab, has announced that the coprimary endpoints of the KEYNOTE-240 trial were not met, as adding the agent to best supportive care failed to improve progression-free or overall survival in patients with advanced hepatocellular carcinoma who were previously treated with systemic therapy.