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Sunitinib Alone Shows Noninferiority Versus Standard of Care in mRCC
June 4th 2018According to findings from the phase III CARMENA trial presented at the 2018 ASCO Annual Meeting, sunitinib monotherapy demonstrated noninferiority compared with cytoreductive nephrectomy in combination with sunitinib in patients with synchronous metastatic renal cell carcinoma.
Mixed Results From 2 Clinical Trials Investigating Pembrolizumab in Myeloma
June 3rd 2018An FDA analysis of data from 2 randomized clinical trials investigating pembrolizumab in multiple myeloma showed inconsistent results regarding the relationship between immune-related adverse events and objective responses. The KEYNOTE-183 and KEYNOTE-185 trials were reviewed during the 2018 ASCO Annual Meeting.
Patients With t(11;14) Myeloma Show Improved Outcomes With Added Venetoclax
June 3rd 2018Patients with relapsed/refractory t(11;14) multiple myeloma achieved high rates of responses when venetoclax was added to the combination of carfilzomib and dexamethasone, according to findings from an ongoing phase II study presented during the 2018 ASCO Annual Meeting.
Prolonged PFS Found With New Carfilzomib Dosing Schedule in Relapsed/Refractory Myeloma
June 3rd 2018According to the phase III ARROW study, a prolonged progression-free survival was found when carfilzomib was administered with a new dosing schedule of 70 mg/m<sup>2</sup> once weekly with dexamethasone compared to the standard of care, a twice-weekly schedule, in patients with relapsed/refractory multiple myeloma.
Cost of CRC Treatment Twice as High in US Than Canada
June 2nd 2018Prices for treatment of metastatic colorectal cancer were more than twice as high for US patients than for their Canadian counterparts, according to a study of costs of treatment in Western Washington (WW) and the province of British Columbia (BC) in Canada.
COA Accuses Government of 'Ongoing Constitutional Violations' in Lawsuit
June 1st 2018The Community Oncology Alliance (COA) has filed a lawsuit to stop the long-running sequester cut that affects Medicare payment for Part B drugs.<sup>1</sup> The cut was renewed this year through the Bipartisan Budget Act of 2018.
Expert Shares Insights on Neoadjuvant and Adjuvant Treatments for Kidney Cancer
June 1st 2018Neoadjuvant and adjuvant therapies are being incorporated into the course of treatment for patients with renal cell carcinoma (RCC), as these approaches may be able to help reduce the risk of recurrence after surgery, according to David M. Nanus, MD. Tyrosine kinase inhibitors (TKIs) and immunotherapy agents especially have demonstrated benefit in the adjuvant setting for patients with high-risk RCC.
FDA Extends Review Period for Lenvatinib in Hepatocellular Carcinoma
June 1st 2018The review period for lenvatinib as a first-line treatment for patients with unresectable hepatocellular carcinoma has been extended by the FDA. According to Eisai and Merck, the companies codeveloping the drug, this will allow ample time to review the application.
Kim Details the Rationale for Regorafenib in GI Cancers
June 1st 2018Richard Kim, MD, recently discussed the treatment considerations and decisions he makes when treating patients with hepatocellular carcinoma. Kim, an associate professor oncology, University of South Florida College of Medicine, and medical oncologist, Gastrointestinal Oncology Department, Moffitt Cancer Center, explained his treatment decisions based on 2 case scenarios during a <em>Targeted Oncology</em> live case-based peer perspectives program.
Frontline Eltrombopag Granted FDA's Priority Review for Severe Aplastic Anemia
May 31st 2018A supplemental new drug application for eltrombopag has been granted a priority review by the FDA for use in combination with standard immunosuppressive therapy as a frontline treatment for patients with severe aplastic anemia, according to Novartis, the manufacturer of the oral thrombopoietin-receptor agonist.
Durvalumab Shows Promise in Patients With NSCLC, Brahmer Says
May 31st 2018Julie Brahmer, MD, recently shared the treatment considerations and decisions she makes when treating patients with non–small cell lung cancer (NSCLC). Brahmer, co-director of the Upper Aerodigestive Department, Johns Hopkins Hospital, in Baltimore, Maryland, discussed her treatment considerations based on case scenarios during a <em>Targeted Oncology </em>live case-based peer perspectives presentation.
FDA Accepts Application for Cabozantinib in Advanced HCC
May 30th 2018A supplemental new drug application seeking the approval of cabozantinib for the treatment of patients with previously-treated advanced hepatocellular carcinoma has been accepted by the FDA, according to a statement from Exelixis, the company developing the agent.
Cabozantinib Receives Frontline Approval in Europe for Advanced RCC
May 30th 2018Cabozantinib has been approved by the European Commission for previously untreated patients with intermediate- or poor-risk advanced renal cell carcinoma, based on a meaningful progression-free survival improvement versus sunitinib in the CABOSUN trial, according to Ipsen, which codevelops the treatment with Exelixis.
Crizotinib Granted Breakthrough Designation by FDA for MET+ NSCLC and ALK+ ALCL
May 30th 2018Crizotinib has been granted a breakthrough therapy designation by the FDA for the treatment of patients with metastatic non–small cell lung cancer with MET exon 14 alterations who progress after receiving platinum-based chemotherapy. Additionally, the kinase inhibitor was granted a designation for use patients with relapsed/refractory ALK+ anaplastic large cell lymphoma.
Two Studies Investigating Daratumumab/Checkpoint Inhibitor Combos in NSCLC, Myeloma Terminated
May 30th 2018Following a planned interim analysis, 2 early-phase clinical trials exploring daratumumab in combination with either a PD-1 inhibitor for multiple myeloma or a PD-L1 inhibitor for non–small cell lung cancer have been terminated, according to a statement from Genmab, the company codeveloping daratumumab with Janssen.
FDA Gives Gilteritinib Priority Review Designation for FLT3+ AML
May 29th 2018Based on data from the ongoing phase III ADMIRAL study, a new drug application for gilteritinib has been granted a priority review by the FDA for the treatment of adult patients with <em>FLT3</em> mutation–positive relapsed or refractory acute myeloid leukemia, according to Astellas Pharma, the manufacturer of the FLT3 inhibitor.
Larotrectinib Granted FDA's Priority Review for NTRK+ Cancers
May 29th 2018A new drug application for larotrectinib has been granted a priority review by the FDA for the treatment of adult and pediatric patients with locally advanced or metastatic solid tumors with an <em>NTRK</em> gene fusion, according to Bayer and Loxo Oncology, the codevelopers of the pan-TRK inhibitor.
Expert Highlights the Challenges and Treatment Options for Relapsed Multiple Myeloma
May 25th 2018The use of triplet regimens for the treatment of patients with relapsed multiple myeloma has become one of the most favorable treatments recently. OPTIMISMM, a phase III trial, investigated bortezomib and dexamethasone with or without pomalidomide as another triplet regimen option for use in earlier lines of therapy, said Peter Voorhees, MD.<br />
Ibrutinib/Obinutuzumab Combo Improves PFS in CLL
May 25th 2018According to topline results from the phase III ILLUMINATE trial, the combination of ibrutinib and obinutuzumab improved progression-free survival compared with chlorambucil plus obinutuzumab in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.
New Abiraterone Acetate Formulation Approved by FDA for mCRPC
May 25th 2018A new formulation of abiraterone acetate in combination with methylprednisolone has been approved by the FDA as a treatment for men with metastatic castration-resistant prostate cancer, according to Sun Pharma, the company commercializing the treatment.
Expert from Rutgers Cancer Institute Discusses Ongoing Trials in MCL
May 24th 2018In an interview with <em>Targeted Oncology, </em>Andrew M. Evens, DO, MSc, discusses the clinical trials that are ongoing at Rutgers for patients with mantle cell lymphoma. He shares some details of the current treatment landscape and how that will evolve as more data becomes available from trials like those at his institution.
Annual Report Shows Cancer Death Rates Continue to Drop, Late-Stage Prostate Cancer Incidences Rise
May 24th 2018According to results from the Annual Report to the Nation on the Status of Cancer, cancer incidence rates have declined in men while remaining stable in women. Additionally, there have been significant declines in cancer death rates, but differences between race and ethnic groups remain.
Six-Gene Signature Predicts Poor PFS in MCL
May 23rd 2018Expression of genes from the B-cell receptor pathway predicted shorter progression-free survival and overall survival in patients with mantle cell lymphoma, according to results from an examination of a subsection of patients in the ongoing Fondazione Italiana Linfomi MCL-0208 clinical trial.
NCCN Selects Wui-Jin Koh as Senior Vice President and Chief Medical Officer
May 22nd 2018Wui-Jin Koh, MD, has been selected as senior vice president and chief medical officer of the National Comprehensive Cancer Network. This is a newly-designed position to oversee the NCCN Oncology Research Program.
Expert Highlights Early Findings for CDK4/6 Inhibition in MCL
May 22nd 2018Palbociclib, a CDK4/6 inhibitor, has demonstrated success against ibrutinib resistance in primary human samples and mantle cell lymphoma cell lines with the mutated BTKC481S protein. Its use has sparked an investigation of combination therapies targeting CDK4 in MCL, said Selina Chen-Kiang, PhD.
Risk of PSA Progression Reduced by 94% With Apalutamide in Nonmetastatic CRPC
May 22nd 2018According to results from a posthoc analysis of the phase III SPARTAN trial, apalutamide (Erleada) lowered the risk of PSA progression by 94% in patients with nonmetastatic castration-resistant prostate cancer.