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.
Selumetinib Approved in Europe for Pediatric Neurofibromatosis Type 1 and Plexiform Neurofibromas
June 22nd 2021The European Commission has granted a conditional approval to selumetinib for the treatment of pediatric patients with symptomatic, inoperable plexiform neurofibromas and neurofibromatosis type 1 who are at least 3 years of age.
Frontline Pembrolizumab Plus Chemo With or Without Bevacizumab Improves Survival in Cervical Cancer
June 22nd 2021Pembrolizumab plus platinum-based chemotherapy with or without bevacizumab significantly improved overall survival and progression-free survival over the same platinum-based chemotherapy regimen with or without bevacizumab in patients with persistent, recurrent, or metastatic cervical cancer—irrespective of PD-L1 status.
Pacritinib May Possess the Potential to Address Unmet Needs in Myelofibrosis
June 22nd 2021For patients with myelofibrosis who have platelets counts of less than 50,000, pacritinib represents a potential therapeutic option that can fill a need that has been unmet with other approved JAK inhibitors, such as ruxolitinib and fedratinib.
Pirtobrutinib Elicits Encouraging Efficacy in CLL, SLL, MCL, & Other Non-Hodgkin Lymphomas
June 21st 2021Pirtobrutinib produced promising efficacy in patients with previously treated chronic lymphocytic leukemia/small lymphocytic lymphoma, those with mantle cell lymphoma and other non-Hodgkin lymphomas, and those who progressed on Richter transformation–directed therapy.
Navigating Newfound Options, MRD Assessment, and Emerging Approaches in Multiple Myeloma
June 21st 2021The expanding therapeutic landscape in multiple myeloma is poised to integrate daratumumab-based quadruplet therapies and novel cellular therapies as standard options for patients with newly diagnosed and relapsed/refractory disease.
Zanubrutinib Approved in China for Relapsed/Refractory Waldenström Macroglobulinemia
June 21st 2021The China National Medical Products Administration has granted a conditional approval to zanubrutinib for the treatment of adult patients with Waldenström macroglobulinemia who have previously received at least 1 therapy.
Garassino Highlights What’s In Store for Lung Cancer
June 21st 2021Patients with lung cancer were identified as an at-risk group for developing severe complications as a result of SARS-CoV-2 infection, and thoracic oncologists were fast to respond with the establishment of the Thoracic Cancers International COVID-19 Collaboration.
FDA, EU Approval Sought for Copanlisib Plus Rituximab for Indolent Non-Hodgkin Lymphoma
June 21st 2021A supplemental new drug application and a marketing authorization application seeking the approval of the combination of copanlisib and rituximab for the treatment of patients with indolent non-Hodgkin lymphoma have been submitted to the FDA and the European Medicines Agency, respectively.
Oncolytic Virus/CAR T-Cell Therapy Combo Shows Preclinical Potential in Solid Tumors
June 19th 2021City of Hope has entered into a licensing agreement with Imugene Ltd. for the patents covering a combination immunotherapy that enables CD19-directed CAR T-cell therapies to target and eradicate difficult-to-treat solid tumors.
Oral Azacitidine Approved in Europe for Frontline Maintenance in AML
June 18th 2021The European Commission has granted full marketing authorization to azacitidine tablets for use as a maintenance therapy in adult patients with acute myeloid leukemia who achieved complete remission or CR with incomplete blood recovery after induction therapy with or without consolidation treatment, and who are not eligible for, or do not choose to proceed to, hematopoietic stem cell transplant.
Frontline Sintilimab Plus Gemcitabine/Platinum Prolongs PFS in Squamous NSCLC
June 18th 2021The addition of sintilimab to standard chemotherapy comprised of gemcitabine and platinum significantly improved progression-free survival with acceptable safety in previously untreated patients with advanced or metastatic squamous non–small cell lung cancer.
KRAS Pathway Opens Door for Patients With Difficult-to-Treat Ovarian Cancer
June 18th 2021Dual blockade of the RAF/MEK and FAK pathways presents an opportunity for investigators to enhance and expand the number of patients with recurrent low-grade serous ovarian cancer who can benefit from targeted therapies.
Symptom Improvement Appears Similar With Momelotinib Vs Ruxolitinib in Myelofibrosis
June 17th 2021Momelotinib can provide clinically relevant and comparable improvement in overall symptom burden and individual symptom items compared with ruxolitinib in patients with intermediate- and high-risk JAK inhibitor–naïve myelofibrosis.