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Entrectinib Granted Priority Review by FDA for NTRK+ Tumors and ROS1+ NSCLC
February 20th 2019Entrectinib has been granted a priority review designation by the FDA as a therapy for select adult and pediatric patients with <em>NTRK</em> fusion–positive locally advanced or metastatic solid tumors, as well as patients with metastatic <em>ROS1</em>-positive non–small cell lung cancer, according to Genentech, the developer of the multikinase inhibitor.
Four-Drug Regimen Demonstrates Promising First-Line Findings for Older Patients With MCL
February 19th 2019The treatment regimen of rituximab, bendamustine, bortezomib, and dexamethasone demonstrated activity and a manageable safety profile as a first-line therapy for patients with mantle cell lymphoma aged 65 years or older, according to findings from a prospective, multicenter phase II study.
Polatuzumab Vedotin Granted Priority Review Designation by FDA for DLBCL
February 19th 2019Polatuzumab vedotin, an antibody-drug conjugate that has demonstrated a 40% complete response rate in patients with relapsed/refractory diffuse large B-cell lymphoma, has been granted a priority review designation by the FDA in combination with bendamustine and rituximab for the treatment of these patients, according to Genentech, the manufacturer of the agent.
Medicare Makes Move Toward CAR T-Cell Therapy Coverage
February 19th 2019To date, there is no national Medicare policy in place to provide coverage for CAR T-cell therapies, which have been proven to be a successful treatment for certain patients with relapsed/refractory cancers. Now, the Centers for Medicare & Medicaid Services has proposed to cover CAR T-cell therapies approved by the FDA under “Coverage with Evidence Development."
Ibrutinib and Palbociclib Combination Active in Previously Treated MCL
February 19th 2019The combination of ibrutinib and palbociclib appeared to be a feasible and active treatment regimen in patients with previously treated mantle cell lymphoma, according to findings from a phase I dose-finding study recently published in <em>Blood</em>.<sup> </sup>
Activity Seen With Sacituzumab Govitecan in Advanced Urothelial Carcinoma
February 18th 2019According to findings from an open-label, single-arm phase I/II basket study presented during the 2019 Genitourinary Cancers Symposium, 14 of 45 patients with relapsed/refractory metastatic urothelial cancer demonstrated an objective response to sacituzumab govitecan, for an objective response rate of 31.1%.
Finasteride Effective in Preventing Prostate Cancer
February 15th 2019According to the final analysis of the Prostate Cancer Prevention Trial, finasteride, an agent commonly used to treat lower urinary tract problems and baldness in men, was safe and effective in reducing the risk of prostate cancer.
Pembrolizumab/Axitinib Combo Receives Priority Review From FDA for Frontline RCC
February 15th 2019A supplemental biologics license application for the combination of pembrolizumab and axitinib has received a priority review designation from the FDA as a frontline treatment for patients with advanced renal cell carcinoma, primarily based on data from the phase III KEYNOTE-426 study.
MDS, AML Risks Rise Significantly Following Chemotherapy in Most Solid Cancers
February 15th 2019The first attempt to quantify therapy-related myelodysplastic syndrome or acute myeloid leukemia in the era of widespread platinum-based chemotherapy has found that tMDS/AML risks were statistically significantly elevated after chemotherapy for 22 of 23 solid cancers, according to a new study in <em>JAMA Oncology.</em>
Lenalidomide Maintenance Improves PFS, OS in Patients With Transplant-Eligible Multiple Myeloma
February 14th 2019Maintenance therapy with lenalidomide (Revlimid) significantly improved progression-free survival compared with observation alone in patients with newly diagnosed multiple myeloma and the benefit was seen in both transplant-eligible and -ineligible groups.
Positive Findings Seen With Lenvatinib in Two Difficult-to-Treat Thyroid Cancer Subtypes
February 14th 2019Lenvatinib demonstrated promising antitumor activity and a manageable toxicity profile in 3 main subtypes of thyroid cancer, according to findings recently published in <em>Future Oncology.</em>
Novel Analog Demonstrates Efficacy in Early Recurrent/Refractory AML
February 13th 2019A novel agent demonstrated efficacy in treating patients with early recurrent or refractory acute myeloid leukemia when administered via continuous intravenous infusion, according to results from a phase I/II trial recently published in <em>Cancer. </em>The agent was also well tolerated among patients.
Split-Dosing of Daratumumab Approved by FDA for Multiple Myeloma
February 13th 2019Based on findings from the phase Ib EQUULEUS (MMY1001) trial, a split-dosing regimen of daratumumab has been approved by the FDA for patients with multiple myeloma, providing physicians the option to split the first infusion of the CD38-directed monoclonal antibody over 2 consecutive days or complete in a single session.
Pembrolizumab Receives Priority Review Designation from FDA for Frontline HNSCC
February 12th 2019Based on data from the phase III KEYNOTE-048 trial, pembrolizumab has received a priority review designation from the FDA alone or in combination with platinum and 5-fluorouracil chemotherapy as a first-line treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma.
Phase III Isatuximab Trial Meets Primary Endpoint of Improving PFS in Relapsed/Refractory Myeloma
February 11th 2019The phase III ICARIA-MM trial has met its primary endpoint of improving progression-free survival with the combination of pomalidomide and low-dose dexamethasone in patients with relapsed/refractory multiple myeloma compared with pomalidomide and dexamethasone alone.
Expert Underscores Importance of Gaining Better Understanding of Mutations in Myelofibrosis
February 8th 2019Angela G. Fleischman, MD, PhD, discusses a clinical trial at her institution investigating the JAK1 inhibitor itacitinib in patients with MF. She also highlights other recent advancements for patients with MF, as well as advancements in other MPNs such as ET and PV.
Review Period for Ruxolitinib in GVHD Extended by FDA
February 8th 2019The review period for a supplemental new drug application for ruxolitinib has been extended by the FDA by 3 months, making the new action date May 24, 2019. The application is seeking the approval of the JAK1/JAK2 inhibitor as a treatment for patients with acute graft-versus-host disease who have had an inadequate response to corticosteroids.<br />
FDA's ODAC Set to Review Selinexor Application in Penta-Refractory Myeloma
February 8th 2019The FDA's Oncologic Drugs Advisory Committee will hold a hearing on February 26, 2019, to discuss a new drug application for selinexor in combination with dexamethasone for the treatment of patients with penta-refractory multiple myeloma.
Targeted Therapy Pioneers Slamon and Druker Awarded Sjoberg Prize
February 8th 2019Clinical researchers Dennis Slamon, MD, PhD, and Brian Druker, MD, were recently honored with the 2019 Sjöberg Prize for their ground-breaking contributions toward targeted therapy for patients with breast cancer and chronic myeloid leukemia, respectively.
