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.
Acalabrutinib/Obinutuzumab Combo Improves PFS in Frontline CLL
June 6th 2019The combination of acalabrutinib (Calquence) and obinutuzumab (Gazyva) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared with obinutuzumab/chlorambucil in patients with previously untreated chronic lymphocytic leukemia, meeting the primary endpoint of the phase III ELEVATE-TN trial.
Ixazomib Phase III Trial Discontinued in AL Amyloidosis
June 6th 2019Ixazomib in combination with dexamethasone did not demonstrate a significant improvement in overall hematologic response compared with standard therapy in patients with relapsed/refractory systemic light-chain amyloidosis, missing one of two primary endpoints in the phase III TOURMALINE-AL1 trial and leading to discontinuation of the study.
Oncology Community Remembers Legendary Researcher Henry T. Lynch
June 6th 2019Henry T. Lynch, MD, the Charles F. and Mary C. Heider Endowed Chair in Cancer Research at Creighton University and a 2019 Giants of Cancer Care® award winner known by many as the “father of cancer genetics,” died June 2 at the age of 91.
FDA Accepts BLA for Luspatercept in MDS, Grants Priority Review in Beta-Thalassemia
June 5th 2019The FDA has accepted a biologics license application for the investigational erythroid maturation agent luspatercept for the treatment of adult patients with very low- to intermediate-risk myelodysplastic syndromes-associated anemia who have ring sideroblasts and require red blood cell (RBC) transfusions, as well as for adult patients with beta-thalassemia-associated anemia who require RBC transfusions.
Work Remains With Immunotherapy in Ovarian Cancer
June 1st 2019Daphne B. Stewart, MD, discusses the progress that has been made with immunotherapy in ovarian cancer, provides insight into the focus on combination therapy with checkpoint inhibitors, and explains the impact of negative trials on the field.
FDA Grants Frontline Daratumumab Regimen Priority Review in Transplant-Eligible Myeloma
May 31st 2019The FDA has granted a priority review designation to a supplemental biologics license application for daratumumab in combination with bortezomib, thalidomide, and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.
Debate Continues Between Primary Debulking and Neoadjuvant Chemo in Advanced Ovarian Cancer
May 31st 2019Stephen J. Lee, MD, discusses the trials that have added to existing controversies regarding the optimal management of patients with newly diagnosed advanced ovarian cancer and highlights best practices for deciding between the approaches.
FDA Updates Gilteritinib AML Label With OS Data
May 30th 2019The FDA approved a supplemental new drug application to update the label for gilteritinib to include final analysis data from the phase III ADMIRAL trial, which demonstrated an improvement in overall survival with the FLT3 inhibitor compared with salvage chemotherapy in adult patients with relapsed/refractory FLT3-mutant acute myeloid leukemia.
FDA Grants Fast Track Designation to ARV-110 for mCRPC
May 30th 2019The FDA has granted a fast track designation to ARV-110, a PROTAC® protein degrader, for use as a treatment of patients with metastatic castration-resistant prostate cancer who have disease progression following ≥2 systemic therapies.
FDA Grants Lasofoxifene Fast Track Designation for ER+/ESR1-Mutant Metastatic Breast Cancer
May 29th 2019The FDA has granted a fast track designation to lasofoxifene for use as a treatment of female patients with estrogen receptor–positive, HER2-negative metastatic breast cancer who harbor ESR1 mutations.
Renowned Urologic Oncologist Selected to Lead Urology/Bladder Cancer Program at NYU Langone Health
May 28th 2019Gary D. Steinberg, MD, a nationally recognized specialist in the surgical management of bladder cancer, has been named director of the Goldstein Urology Bladder Cancer Program at NYU Langone Health.
FDA Approves Alpelisib for Breast Cancer
May 24th 2019The FDA has approved the PI3K inhibitor alpelisib (Piqray) for the treatment of postmenopausal women, and men, with HR-positive, HER2-negative, PIK3CA-mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen.
FDA Grants LN-145 Breakthrough Designation for Cervical Cancer
May 24th 2019The FDA has granted a breakthrough therapy designation to the tumor-infiltrating lymphocyte therapy LN-145 for the treatment of patients with recurrent, metastatic, or persistent cervical cancer with disease progression on or after chemotherapy.