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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.
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.