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.
Tiragolumab Plus Atezolizumab/Chemo Misses PFS End Point in Extensive-Stage SCLC
March 30th 2022The addition of the anti-TIGIT immunotherapy tiragolumab to atezolizumab plus carboplatin/etoposide failed to significantly improve progression-free survival over atezolizumab/chemotherapy alone when used in the frontline treatment of patients with extensive-stage small cell lung cancer, missing the co-primary end point of the phase 3 SKYSCRAPER-02 trial.
Adding Uproleselan to Chemo Could Reduce Chemotherapy-Induced Mucositis in Relapsed/Refractory AML
March 30th 2022Daniel J. DeAngelo, MD, PhD, discusses how the addition of uproleselan to various chemotherapy backbones is being investigated in ongoing clinical trials, plus the encouraging safety data tied to the lowered mucositis levels.
FDA Grants Priority Review to Futibatinib for FGFR2+ Advanced Cholangiocarcinoma
March 30th 2022The FDA has granted priority review to a new drug application seeking the approval of futibatinib in the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma harboring FGFR2 gene rearrangements, including gene fusions.
Targeted Combo Notches Rare Success in Glioblastoma
March 30th 2022Encouraging response rates to a dual-targeted regimen in patients with recurrent or refractory malignant brain tumors with BRAF V600E mutations were reported in 2021, representing a new potential targeted therapy strategy against glioblastoma.
European Approval Sought for Neoadjuvant Nivolumab/Chemo in Resectable NSCLC
March 29th 2022The European Medicines Agency has validated its type II variation application for nivolumab in combination with chemotherapy for use in the neoadjuvant treatment of patients with unresectable stage IB to IIIA non–small cell lung cancer.
FDA Approval Sought for Mirvetuximab Soravtansine in Ovarian Cancer
March 29th 2022A biologics license application has been submitted to the FDA for the use of mirvetuximab soravtansine monotherapy in patients with platinum-resistant ovarian cancer and high folate receptor–alpha expression who have received 1 to 3 prior systemic treatments.
Precursor Conditions Unlock Potential for Early Interventions in Multiple Myeloma
March 29th 2022Data presented at the ASH Annual Meeting and Exposition underscored the growing focus on improving screening, advancing methods of detection, and improving our understanding of the genomic, genetic, and epigenetic factors that govern progression and therapeutic resistance in multiple myeloma.
Lisocabtagene Maraleucel sNDA for Second-Line Relapsed/Refractory LBCL Accepted for Review in Japan
March 26th 2022The Ministry of Health, Labour, and Welfare has accepted a supplemental new drug application for lisocabtagene maraleucel for the second-line treatment of patients with relapsed or refractory large B-cell lymphoma.
FDA Extends Review Period for Luspatercept-aamt in Non–Transfusion-Dependent Beta Thalassemia
March 25th 2022The FDA has extended the review period for the supplemental biologics license application for luspatercept-aamt as a treatment for anemia in adults with non–transfusion-dependent β-thalassemia.
FDA Discourages Pursuit of Marketing Authorization for Zandelisib in MZL, Follicular Lymphoma
March 25th 2022The FDA has discouraged the pursuit of a marketing authorization of the PI3K inhibitor zandelisib in patients with follicular lymphoma or marginal zone lymphoma, citing the need for randomized trial data.
Avapritinib Approved in Europe for Advanced Systemic Mastocytosis
March 25th 2022The European Commission has expanded the current indication for avapritinib to include use as a single agent in adult patients with aggressive systemic mastocytosis, systemic mastocytosis with an associated hematologic neoplasm, or mast cell leukemia, following at least 1 systemic treatment.
CHMP Moves to Recommend Pembrolizumab for MSI-H/dMMR Cancers
March 25th 2022The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended pembrolizumab for the treatment of adult patients with a variety of microsatellite instability-high or mismatch repair deficient tumors.
Polatuzumab Vedotin Plus R-CHP Recommended for EU Approval for Previously Untreated DLBCL
March 25th 2022The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion in favor of the approval of polatuzumab vedotin for use in combination with rituximab plus cyclophosphamide, doxorubicin, and prednisone in patients with previously untreated diffuse large B-cell lymphoma.
EU Panel Recommends Ruxolitinib for Acute or Chronic Graft-Vs-Host Disease
March 25th 2022The European Medicines Agency’s Committee for Medical Products for Human Use has recommended the approval of ruxolitinib for the treatment of patients with acute or chronic graft-vs-host disease who are aged 12 years or older and who have inadequate response to corticosteroids or other systemic therapies.