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.
FDA Approves Adjuvant T-DM1 in HER2+ Early Breast Cancer
May 4th 2019The FDA has approved ado-trastuzumab emtansine (T-DM1; Kadcyla) for use as an adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease following neoadjuvant trastuzumab and chemotherapy.
Chemoimmunotherapy Combos Solidified as Frontline Standard in Nonsquamous NSCLC
May 3rd 2019The rationale for frontline chemoimmunotherapy in stage IV nonsquamous non–small cell lung cancer, now made evident by several phase III trials, stems from its synergistic activity, stimulatory effects on neoantigens, and tolerable safety profile.
Frontline Cabozantinib Plus Nivolumab/Ipilimumab Explored in Phase III RCC Trial
May 2nd 2019In an effort to improve outcomes for intermediate- or poor-risk patients with renal cell carcinoma, the phase III COSMIC-313 trial is being initiated, which will evaluate cabozantinib (Cabometyx) in combination with nivolumab and ipilimumab in patients with previously untreated advanced disease.
FDA Approves Ivosidenib for Frontline IDH1+ AML
May 2nd 2019The FDA has approved a supplemental new drug application for ivosidenib as a single agent for the first-line treatment of adult patients with IDH1-mutant acute myeloid leukemia, as detected by an FDA-approved test, who are ≥75 years old or are ineligible to receive intensive chemotherapy.
Talazoparib Approaches EU Approval for BRCA-Mutated, HER2-Negative Breast Cancer
April 30th 2019The European Medicines Agency's Committee for Medicinal Products for Human Use has backed approval of talazoparib (Talzenna) for adult patients with HER2-negative locally advanced or metastatic breast cancer harboring germline BRCA1/2 mutations.
EU Panel Recommends Revoking Olaratumab in Soft Tissue Sarcoma
April 29th 2019The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended that the conditional marketing authorization for olaratumab be revoked following results of the ANNOUNCE study, which did not demonstrate a survival benefit with the PDGFRα antagonist in combination with doxorubicin versus doxorubicin alone in patients with advanced or metastatic soft tissue sarcoma.
Cemiplimab Nears EU Approval for CSCC
April 29th 2019The European Medicines Agency's Committee for Medicinal Products for Human Use issued a positive opinion recommending approval of cemiplimab for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation, according to Regeneron Pharmaceuticals, the manufacturer of the PD-1 inhibitor.
USC Norris Launches Diversity-Driven Study Among Clinical Trial Participants
April 29th 2019USC Norris Comprehensive Cancer Center has launched a study to determine how financial assistance for costs associated with clinical trial participation might increase enrollment, particularly among low-income patients and racial and ethnic minorities.
EU Panel Backs Olaparib Approval for Frontline Maintenance in Ovarian Cancer
April 29th 2019The European Committee for Medicinal Products for Human Use has recommended approval of olaparib as a frontline maintenance treatment for patients with BRCA-mutant advanced high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response following first-line platinum-based chemotherapy.
European Approval Sought for Luspatercept for Anemias
April 26th 2019A marketing authorization application has been submitted to the European Medicines Agency for luspatercept for the treatment of adult patients with very low- to intermediate-risk myelodysplastic syndrome–associated anemia with ring sideroblasts who require red blood cell transfusions and have not received or are ineligible to receive erythropoiesis-stimulating agents.
Pembrolizumab/Chemo Combo Misses OS Endpoint in Advanced Gastric/GEJ Cancer
April 26th 2019The combination of pembrolizumab (Keytruda) and chemotherapy did not improve overall survival or progression-free survival compared with standard chemotherapy alone for the frontline treatment of patients with advanced gastric or gastroesophageal junction adenocarcinoma.
Frontline Lenalidomide/R-CHOP Combo Misses Primary Endpoint in DLBCL
April 26th 2019The combination of lenalidomide (Revlimid) with rituximab (Rituxan), cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP; R2-CHOP) did not improve progression-free survival compared with placebo and R-CHOP as a frontline therapy in patients with activated B-cell-type diffuse large B-cell lymphoma, missing the primary endpoint of the phase III ROBUST trial.