The OncLive® News page includes the latest in clinical oncology news, including breaking regulatory decisions, clinical trial findings, pivotal and practice-changing data published in academic peer-reviewed journals, and more across solid and hematologic malignancies. Regulatory news includes new drug approvals by the FDA and European Union, priority review and breakthrough therapy designations, and orphan drug and fast track statuses.
Frontline Daratumumab/VRd Regimen Improves sCR Rate in Transplant-Eligible Myeloma
July 9th 2019The quadruplet regimen of daratumumab, lenalidomide, bortezomib, and dexamethasone elicited a higher stringent complete response rate compared with lenalidomide, bortezomib, and dexamethasone alone in patients with transplant-eligible, newly diagnosed multiple myeloma, meeting the primary endpoint of the phase II GRIFFIN study.
FDA Approves Selinexor in Relapsed/Refractory Multiple Myeloma
July 3rd 2019The FDA has granted an accelerated approval to selinexor in combination with dexamethasone for the treatment of adult patients with relapsed/refractory multiple myeloma who have received ≥4 prior therapies and whose disease is refractory to ≥2 proteasome inhibitors, ≥2 immunomodulatory agents, and a CD38-targeted monoclonal antibody.
Napabucasin Phase III Trial Discontinued in Pancreatic Cancer
July 3rd 2019The CanStem111P trial, which was evaluating the combination of napabucasin, weekly nab-paclitaxel (Abraxane), and gemcitabine compared with nab-paclitaxel/gemcitabine alone in patients with metastatic pancreatic ductal adenocarcinoma, will be discontinued due to futility.
Expert Highlights CAR-T and Other Treatment Advances Across Hematologic Malignancies
July 2nd 2019Mazyar Shadman, MD, MPH, discusses earlier use of CAR T-cell therapy in lymphoma, the impact of approved products on future development, and recent data with chemotherapy-free and time-limited therapy in chronic lymphocytic leukemia.
Dimopoulos Highlights Benefit of Elotuzumab Triplet in Relapsed/Refractory Myeloma
July 2nd 2019Meletios A. Dimopoulos, MD, discusses where the triplet combination of elotuzumab (Empliciti), pomalidomide (Pomalyst), and low-dose dexamethasone fits into the treatment paradigm of relapsed/refractory multiple myeloma and shared unanswered questions that remain in the space.
Cemiplimab Approved in Europe for Cutaneous Squamous Cell Carcinoma
July 1st 2019The European Commission approved cemiplimab (Libtayo) for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation.
Lead Investigator Highlights Apalutamide Efficacy in Metastatic Castration-Sensitive Prostate Cancer
July 1st 2019Kim Chi, MD, discusses how the next-generation androgen receptor inhibitor apalutamide in combination with androgen deprivation therapy could be a new standard of care for patients with metastatic castration-sensitive prostate cancer.
EU Panel Backs Expanded Indication of Ibrutinib Combos in CLL and Waldenstrom Macroglobulinemia
June 28th 2019The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended expanding the indications of ibrutinib (Imbruvica) to include use in combination with obinutuzumab (Gazyva) for adult patients with previously untreated chronic lymphocytic leukemia, and also in combination with rituximab (Rituxan) for the treatment of adult patients with Waldenström’s macroglobulinemia.
Atezolizumab Combo Approaches EU Approval for Frontline TNBC
June 28th 2019The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of the frontline combination of atezolizumab (Tecentriq) plus nab-paclitaxel (Abraxane) for the treatment of adult patients with unresectable locally advanced or metastatic PD-L1–positive triple-negative breast cancer.
FDA Approves Bevacizumab Biosimilar
June 28th 2019The FDA has approved PF-06439535, a bevacizumab biosimilar, for the treatment of patients with metastatic colorectal cancer; unresectable, locally advanced, recurrent, or metastatic nonsquamous non–small cell lung cancer; recurrent glioblastoma; metastatic renal cell carcinoma; and persistent, recurrent, or metastatic cervical cancer.
FDA Approves Frontline Daratumumab/Rd in Transplant-Ineligible Myeloma
June 28th 2019The FDA has approved the combination of daratumumab with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation.