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Frontline Venetoclax Combo Submitted for FDA Approval in AML
July 13th 2018The FDA has received a supplemental New Drug Application for venetoclax in combination with a hypomethylating agent or low-dose cytarabine as a frontline treatment for patients with acute myeloid leukemia who are ineligible for intensive chemotherapy, Genentech, the manufacturer of the BCL-2 inhibitor, has announced.
Obinutuzumab Appears Safe, Effective in Relapsed/Refractory CLL
July 12th 2018An updated analysis of obinutuzumab alone or in combination with chemotherapy for patients with treatment-naïve or relapsed/refractory chronic lymphocytic leukemia detected no new safety signals. Investigators in the phase IIIb GREEN trial also found overall response rates greater than 80% at 3 months post-treatment in some patients.
Promising Activity Seen With Palbociclib/Cetuximab Combo in HPV-Unrelated HNSCC
July 12th 2018An overall response rate of 39% was induced with the combination of the CDK4/6 inhibitor palbociclib and cetuximab in patients with platinum-resistant, HPV-unrelated recurrent/metastatic head and neck squamous cell carcinoma.
Pembrolizumab Granted Priority Review by FDA for HCC
July 12th 2018The PD-1 inhibitor pembrolizumab (Keytruda) has been granted a priority review designation by the FDA for use in previously treated patients with advanced hepatocellular carcinoma, according to Merck, the manufacturer of the agent.
Patients With Multiple Myeloma See Improved PFS With Maintenance Ixazomib
July 11th 2018In topline findings from the phase III TOURMALINE-MM3 study, maintenance treatment with the proteasome inhibitor ixazomib improved progression-free survival compared with placebo in adult patients with multiple myeloma who responded to high-dose therapy and autologous stem cell transplant.
Nivolumab Plus Ipilimumab Approved by FDA in MSI-H/dMMR Colorectal Cancer
July 11th 2018An accelerated approval has been granted by the FDA for the combination of nivolumab plus ipilimumab for the treatment of both adult and pediatric patients, over the age of 12 years, with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer, following progression on treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
Komrokji Reveals Therapeutic Strategies for Patients with AML
July 10th 2018Rami S. Komrokji, MD, recently discussed the treatment considerations and decisions he makes when treating patients with acute myeloid leukemia. Komrokji, professor of oncologic sciences, University of South Florida, and vice chair of the Department of Hematologic Malignancies, Moffitt Cancer Center, explained his treatment decisions based on 2 case scenarios during a <em>Targeted Oncology</em> live case-based peer perspectives presentation.
Pixantrone Fails to Prolong PFS in Phase III B-Cell NHL Trial
July 10th 2018Progression-free survival was not improved by combining pixantrone with rituximab compared with gemcitabine plus rituximab in patients with aggressive B-cell non-Hodgkin lymphoma enrolled in the phase III PIX306 trial, according to CTI BioPharma, the manufacturer of pixantrone.
Addition of Elotuzumab Significantly Prolongs PFS in Heavily Pretreated Myeloma
July 9th 2018Elotuzumab (Empliciti) added to pomalidomide (Pomalyst) and dexamethasone reduced the risk of disease progression by 46% in patients with relapsed/refractory multiple myeloma compared with pomalidomide and dexamethasone alone, according to findings from the phase II ELOQUENT-3 trial presented at the 2018 EHA Congress.
Expert Highlights Recent Daratumumab Data in Myeloma
July 9th 2018In an analysis of patients with relapsed/refractory multiple myeloma enrolled on the phase Ib MMY1001 trial, daratumumab (Darzalex) was shown to be safe and effective when added to the backbone of carfilzomib (Kyprolis) and dexamethasone. These findings, which were presented during the 2018 ASCO Annual Meeting, signaled promising efficacy in patients who are refractory to lenalidomide (Revlimid), according to lead study author Ajai Chari, MD.
Real-World Data Shows Consistent Benefit With TAS-102 in mCRC
July 9th 2018Consistent benefits and safety were seen with TAS-102 (trifluridine/tipiracil; Lonsurf) in a real-world treatment setting for patients with refractory metastatic colorectal cancer, according to preliminary data from the phase IIIb open-label PRECONNECT trial.
Regorafenib Dose-Escalation Strategy Superior to Standard Dosing in mCRC
July 6th 2018A strategy of escalating regorafenib from 80 mg to 160 mg per day was superior to starting at a dose of 160 mg per day in patients with refractory metastatic colorectal cancer, according to results from the regorafenib dose optimization study presented at the 2018 World Congress on GI.
Are User Fees the Solution for Abuse of the 340B Program?
July 6th 2018Representative Chris Collins recently proposed a bill that could provide the Health Resources and Serves Administration with additional resources to regulate the 340B Drug Discount Program. The 340 Drug Discount Accountability Act was introduced in the House of Representatives on June 27. If passed, the act would require that all participating hospitals document their total 340B drug purchases and pay a user fee of 0.1% to the HRSA.
Patel Considers a New Standard of Care When Treating Patients With NSCLC
July 6th 2018Jyoti D. Patel, MD, recently shared the treatment considerations and decisions she makes when treating patients with non–small cell lung cancer. Patel, professor of medicine and director of thoracic oncology at the University of Chicago Medicine in Illinois, discussed her treatment considerations for patients with NSCLC based on case scenarios during a <em>Targeted Oncology </em>live case-based peer perspectives presentation.
Dasatinib Granted Approval in Europe for Pediatric Ph+ Chronic Phase CML
July 5th 2018Dasatinib has been granted approval by the European Commission as a treatment for children and adolescent patients aged 1 to 18 years with Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase, according to Bristol-Myers Squibb, the manufacturer of the tyrosine kinase inhibitor.
Atezolizumab Fails to Demonstrate Superior Survival Over Regorafenib in mCRC
July 5th 2018According to findings from the IMblaze370 study, atezolizumab alone or in combination with cobimetinib did not demonstrate superior overall survival when compared with regorafenib for the treatment of patients with chemorefractory metastatic colorectal cancer. Findings from the study were presented at the 2018 World Congress on Gastrointestinal Cancer.
CPX-351 Recommended for Approval by EMA Committee for 2 Types of AML
July 5th 2018CPX-351, a fixed-combination of daunorubicin and cytarabine, has been recommended for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use for the treatment of adult patients with newly diagnosed therapy-related acute myeloid leukemia or AML with myelodysplasia-related changes.
No Survival Benefit Found With Pembrolizumab in PD-L1 ≥1 Gastric/GEJ Cancers
July 3rd 2018According to findings from the phase III KEYNOTE-061 study, second-line treatment with pembrolizumab (Keytruda) did not significantly improve overall survival or progression-free survival compared with paclitaxel in patients with advanced or metastatic gastric or gastroesophageal junction cancer with a PD-L1 combined positive score ≥1.
Three Oncology Researchers Share Tang Prize
July 3rd 2018Three oncology researchers whose discoveries have advanced the field of targeted therapies in cancer care are jointly being awarded the 2018 Tang Price in Biopharmaceutical Science, which will be presented during a ceremony on September 21 in Taipei, Taiwan.
Analysis Shows Incidence of Cardiovascular Toxicities Associated With ICIs
July 3rd 2018Immune checkpoint inhibitors, alone or in combination, are associated with increased incidence of some cardiovascular toxicities in patients with cancer, according to results from a cross-trial pooled analysis presented in a poster at the 2018 ASCO Annual Meeting.
A Look Back at FDA News in June
July 2nd 2018The FDA approved several indications in the month of June, including venetoclax (Venclexta) in chronic lymphocytic leukemia (CLL) and small lymphocytic leukemia (SLL), the combination of binimetinib (Mektovi) plus encorafenib (Braftovi) in melanoma, and bevacizumab (Avastin) in ovarian cancer. The FDA also accelerated approvals for pembrolizumab (Keytruda) in cervical cancer and in primary mediastinal large B-cell lymphoma, while also granting a priority review to glasdegib for acute myeloid leukemia.
Frontline Pembrolizumab Regimen Granted Priority Review by FDA for Squamous NSCLC
July 2nd 2018A supplemental biologics license application for first-line pembrolizumab (Keytruda) for use in combination with carboplatin/paclitaxel or nab-paclitaxel (Abraxane) has been granted a priority review by the FDA for the treatment of patients with metastatic squamous non–small cell lung cancer, regardless of PD-L1 expression.
Expert Provides Insight on Shifting SCLC Treatment Landscape
July 2nd 2018Immunotherapy may provide an opportunity to change the treatment paradigm of small cell lung cancer as new clinical trials report out in the next year, says Anne Chiang, MD, PhD. Recent results with immunotherapy agents in the second-line setting have already influenced guidelines.