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.
JZP458 Receives CHMP Recommendation for Approval in ALL, Lymphoblastic Lymphoma
July 21st 2023The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of JZP458 for use in combination with multi-agent chemotherapy for the treatment of adult and pediatric patients 1 month and older with acute lymphoblastic leukemia and lymphoblastic lymphoma who developed hypersensitivity or silent inactivation to Escherichia coli–derived asparaginase.
Teclistamab Snags Positive CHMP Opinion for Relapsed/Refractory Multiple Myeloma
July 21st 2023The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of a Type II variation for teclistamab in the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 3 prior therapies.
CHMP Recommends Talquetamab Monotherapy for R/R Multiple Myeloma
July 21st 2023The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended conditional marketing authorization of talquetamab for use as a single agent in adult patients with relapsed or refractory multiple myeloma who have previously received at least 3 therapies.
Adjuvant Nivolumab Receives CHMP Recommendation for Completely Resected Stage IIB/C Melanoma
July 21st 2023The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of nivolumab monotherapy for the adjuvant treatment of patients at least 12 years of age with completely resected stage IIB or IIC melanoma.
Epcoritamab Approaches EU Approval for Relapsed/Refractory DLBCL
July 21st 2023The European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion recommending conditional marketing authorization to epcoritamab monotherapy for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma after 2 or more lines of systemic therapy.
FDA Approves Quizartinib Plus Chemotherapy for Newly Diagnosed, FLT3-ITD+ AML
July 20th 2023The FDA has approved quizartinib in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia that is FLT3-ITD positive, as detected by an FDA-approved test.
Rini Expands on Key Clinical Trial Updates in GU Cancers from the 2023 ASCO Annual Meeting
July 20th 2023Brian I. Rini, MD, FASCO, highlights key clinical trial updates from the genitourinary cancers landscape presented at the 2023 ASCO Annual Meeting, details the implications of the CONTACT-03 data, expands on the long-term data from the phase 3 KEYNOTE-426 trial in clear cell RCC, discusses findings from the phase 3 TALAPRO-2 trial in patients with metastatic castration-resistant prostate cancer, and more.
APVO436 Plus Venetoclax/Azacitidine Produces Durable Remissions in Relapsed/Refractory AML
July 20th 2023Treatment with the CD3 x CD123 bispecific antibody APVO436 plus venetoclax and azacitidine led to durable remissions in patients with relapsed/refractory acute myeloid leukemia who had not received prior venetoclax.
China’s NMPA Accepts sNDA for First-Line Toripalimab Plus Chemo in ES-SCLC
July 20th 2023China’s National Medical Products Administration has accepted a supplemental new drug application seeking the approval of toripalimab in combination with platinum-based chemotherapy for the first-line treatment of patients with extensive-stage small cell lung cancer.
Tislelizumab Plus Bevacizumab/Chemo Demonstrates Early Efficacy in Cervical Cancer
July 20th 2023The addition of the PD-L1 inhibitor tislelizumab to standard bevacizumab and platinum-doublet chemotherapy in the first-line setting prolonged progression-free survival, produced encouraging responses, and was well tolerated in patients with cervical cancer.
FDA Awards Fast Track Designation to ARX517 for Metastatic Castration-Resistant Prostate Cancer
July 20th 2023The FDA has granted fast track designation to ARX517 for use as a potential treatment option in patients with metastatic castration-resistant prostate cancer who experience disease progression on an androgen receptor pathway inhibitor.
Bexmarilimab Plus SOC Continues to Show Early Activity in R/R AML and MDS
July 19th 2023Bexmarilimab in combination with standard-of-care azacitidine or azacitidine plus venetoclax demonstrated early signs of efficacy in patients with relapsed or refractory acute myeloid leukemia and myelodysplastic syndrome.
Diagnostic Advances Distinguish Actionable Drivers of Early Progression in ER+ Breast Cancer
July 19th 2023Ahmed Elkhanany, MD discusses unmet needs in patients with estrogen receptor–positive breast cancer who progress on frontline therapy, treatment considerations for these patients, and how FES PET imaging may benefit this population.
Phase 1b Data Support Continued Investigation of Acalabrutinib Plus BR in MCL
July 19th 2023Tycel Phillips, MD, discusses the rationale and design of a phase 1b trial investigating acalabrutinib plus bendamustine and rituximab in patients with mantle cell lymphoma, highlights key efficacy and safety findings in the treatment-naïve and relapsed/refractory patient cohorts, and postulated next steps on the horizon for investigating BTK inhibitors in combination with chemotherapy in this patient population.
Theseus Pharmaceuticals Terminates Development of THE-630 in Gastrointestinal Stromal Tumors
July 19th 2023Theseus Pharmaceuticals has announced that the development of THE-630 as a potential therapeutic option for patients with gastrointestinal stromal tumor has been terminated, and enrollment to the ongoing phase 1/2 trial evaluating the agent’s safety and efficacy in this population has been discontinued.
Time to Treatment Matters After a Cancer Diagnosis
July 19th 2023Finding a comprehensive cancer care provider that is able to provide patients with swift and easy access to the highest-quality diagnosis and treatment planning is essential to reducing stress and ensuring patients achieve the best possible outcomes.
FDA Grants Fast Track Status to Selinexor for Myelofibrosis
July 19th 2023The FDA has granted a fast track designation to selinexor for use in the treatment of patients with myelofibrosis, including primary myelofibrosis, post–essential thrombocytopenia myelofibrosis, and post–polycythemia vera myelofibrosis.
Combination Approaches Are on the Horizon in Later-Line HER2+ Breast Cancer Management
July 18th 2023Adrienne G. Waks, MD, spotlights the need to understand mechanisms of resistance to second-line HER2-positive breast cancer therapies, chemotherapy-free regimens with later-line treatment potential, and the future of HER2-positive disease management.
Breast Cancer Research Breakthroughs Signal Paradigm Shifts Across Disease Subsets
July 18th 2023Maryam Lustberg, MD, MPH, discusses insights regarding other key breast cancer data presented at the 2023 ASCO Annual Meeting, including findings from the phase 3 BWEL trial, updated data from the phase 2 ELAINE-2 trial, and the final overall survival analysis of the phase 3 TROPiCS-02 trial.