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.
Patritumab Deruxtecan Under Exploration in Phase 2 HERTHENA-Lung01 Trial for EGFR+ NSCLC
April 1st 2021The HER3-directed antibody-drug conjugate patritumab deruxtecan is under exploration in the treatment of patients with EGFR-mutated, metastatic or locally advanced non–small cell lung cancer who had previously received a TKI and platinum-based chemotherapy.
Duvelisib Granted Positive EU Opinion for Relapsed/Refractory CLL and Refractory Follicular Lymphoma
April 1st 2021The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the approval of single-agent duvelisib for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia following at least 2 prior therapies, and follicular lymphoma that is refractory to at least 2 prior systemic treatments.
FDA Grants Breakthrough Therapy Designation to Futibatinib for FGFR2+ Advanced Cholangiocarcinoma
April 1st 2021The FDA has granted a breakthrough therapy designation to the FGFR inhibitor futibatinib for the treatment of patients with previously treated, locally advanced or metastatic cholangiocarcinoma that harbors FGFR2 gene rearrangements, including fusions.
OncLive® Takes a Look Back at Most Listened Podcasts of 2020
April 1st 2021Digital media, now more than ever, has become a primary platform for communication, and in 2020, the production of the OncLive® podcast, OncLive On Air™, was put into overdrive to bring practicing oncologists exclusive biweekly interviews, discussions, and insights from leading experts in cancer care.
Approval Sought for Plinabulin Plus G-CSF in United States and China for Prevention of CIN
April 1st 2021A new drug application has been submitted to the FDA and the China National Medical Products Administration for the use of plinabulin plus granulocyte colony-stimulating factor for the prevention of chemotherapy-induced neutropenia.
Navitoclax Shows Early Signs of Clinical Benefit in Myelofibrosis
April 1st 2021The combination of navitoclax and ruxolitinib simultaneously inhibits 2 key mechanisms that promote myelofibrosis, resulting in an improvement in symptom control and positive changes in response biomarkers in patients with high-risk disease.
FDA Approves Isatuximab Plus Carfilzomib/Dexamethasone for Relapsed/Refractory Multiple Myeloma
March 31st 2021The FDA has approved isatuximab in combination with carfilzomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have previously received 1 to 3 lines of therapy.
HEPZATO Demonstrates Promising Preliminary Activity in Metastatic Ocular Melanoma
March 31st 2021HEPZATO KIT has demonstrated statistically significant benefit compared to best alternative care in patients with liver-dominant metastatic ocular melanoma, according to preliminary results from the phase 3 FOCUS trial.
Rolling Submission Completed for Pacritinib for Myelofibrosis With Severe Thrombocytopenia
March 31st 2021The rolling submission of a new drug application has been completed and submitted to the FDA to support the approval of pacritinib as a treatment for patients with myelofibrosis and severe thrombocytopenia defined as having platelet counts less than 50 x 109/L.
Novel NTD Inhibitor EPI-7386 Plus Enzalutamide Under Evaluation in mCRPC
March 31st 2021The first-in-class N-terminal domain androgen receptor inhibitor EPI-7386 is being examined in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer as part of a phase 1/2 trial.
Canadian Collaborative Launches to Provide Infrastructure for Cancer Cell Therapy Research
March 31st 2021The Canada Foundation for Innovation has awarded C$5,187,685 to the Canadian Cancer Trials Group at Queen’s University in Kingston, Ontario, Canada, to fund the infrastructure for a new research platform to coordinate the development of new cancer cell therapies.
COVID-19 and Cancer Care: Lessons Learned 1 Year Later
March 31st 2021From delayed diagnoses, to the emergence of telemedicine, to managing the increased emotional burden experienced by patients and healthcare professionals alike, the community has been forced to approach cancer care in ways they never had before in light of the COVID-19 pandemic.
FDA Approves Daunorubicin/Cytarabine for Pediatric Secondary AML
March 30th 2021The FDA has approved a revised label for daunorubicin/cytarabine (Vyxeos) to include the treatment of pediatric patients aged 1 year and older with newly diagnosed, therapy-related acute myeloid leukemia (AML) or AML with myelodysplasia-related changes.
On the Move: Narjust Duma Named Associate Director of the Cancer Equity Program at Dana-Farber
March 30th 2021Narjust Duma, MD, has been named as the new associate director of the Cancer Care Equity Program at the Dana-Farber Cancer Institute, as well as an assistant professor of medicine at Harvard Medical School.
NCCN Updates Guidelines to Include Tivozanib as Recommended Regimen in Clear Cell RCC
March 30th 2021The National Comprehensive Cancer Network has updated its Clinical Practice Guidelines to include tivozanib as a recommended regimen for subsequent therapy in patients with clear cell renal cell carcinoma.
Gilteritinib Succeeds in Chinese Confirmatory Trial for FLT3-Mutated AML
March 30th 2021Gilteritinib was found to result in a significant improvement in overall survival when used in patients with FLT3-mutated, relapsed/refractory acute myeloid leukemia, meeting the primary end point of the confirmatory phase 3 COMMODORE trial in China.
Enzalutamide Granted Positive EU Opinion for Metastatic Hormone-Sensitive Prostate Cancer
March 30th 2021The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion to recommend an additional indication of enzalutamide for the treatment of adult patients with metastatic hormone-sensitive prostate cancer.
NCCN Guidelines Include an Abundance of Options Across Multiple Myeloma Paradigm
March 30th 2021The National Comprehensive Cancer Network guidelines for the management of frontline and relapsed/refractory multiple myeloma were updated to incorporate novel agents and combination strategies, providing a wide range of category 1 recommended therapies for patients.