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.
Blinatumomab Approaches European Approval for MRD+ ALL
November 17th 2018The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of blinatumomab for the treatment of adult patients with B-cell precursor acute lymphoblastic leukemia who are in remission but still have minimal residual disease of at least 0.1%.
EU Panel Backs Expanding Ribociclib Approval in HR+/HER2- Breast Cancer
November 17th 2018The European Medicine’s Agency Committee for Medicinal Products for Human Use has recommended expanding the approval of ribociclib (Kisqali) in women with HR+/HER2-negative breast cancer to include use in combination with fulvestrant (Faslodex).
Durvalumab Combo Misses OS Endpoint in Frontline Metastatic NSCLC
November 16th 2018The frontline combination of durvalumab (Imfinzi) and tremelimumab did not induce a statistically significant improvement in overall survival compared to standard chemotherapy in patients with metastatic non–small cell lung cancer.
Cabozantinib Approved in Europe for Second-Line HCC
November 16th 2018The European Commission has approved cabozantinib (Cabometyx) for the treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib (Nexavar), according to Ipsen, which develops the multikinase inhibitor with Exelixis.
FDA Grants Brentuximab Vedotin Breakthrough Designation for Frontline CD30+ PTCL
November 16th 2018The FDA has granted brentuximab vedotin a breakthrough therapy designation for use in combination with chemotherapy for the frontline treatment of patients with CD30-expressing peripheral T-cell lymphoma.
Pegylated Doxorubicin/Carboplatin Plus Bevacizumab Improves PFS in Recurrent Ovarian Cancer
November 14th 2018The combination regimen of pegylated liposomal doxorubicin with bevacizumab was found to significantly improve progression-free survival versus carboplatin/gemcitabine in select patients with recurrent ovarian cancer.
Long-Term Maintenance Olaparib Safe and Effective for Patients With Recurrent Ovarian Cancer
November 14th 2018Long-term maintenance therapy with olaparib (Lynparza) tablets demonstrated a low rate of treatment discontinuation and tolerable safety profile in patients with platinum-sensitive recurrent ovarian cancer.
FDA Grants Atezolizumab Combo Priority Review for Frontline TNBC
November 13th 2018The FDA has granted a priority review designation to a supplemental biologics license application for the frontline combination of atezolizumab plus nab-paclitaxel for patients with unresectable locally advanced or metastatic PD-L1–positive triple-negative breast cancer.
Lurbinectedin Does Not Improve PFS in Platinum-Resistant Ovarian Cancer
November 12th 2018Results of the phase III CORAIL trial demonstrated that the marine-derived treatment lurbinectedin did not improve progression-free survival compared with pegylated liposomal doxorubicin or topotecan in patients with platinum-resistant ovarian cancer.
FDA Grants Olaparib Priority Review for Frontline Maintenance in Ovarian Cancer
November 12th 2018The FDA has granted a priority review designation to a supplemental new drug application for olaparib tablets for use as a maintenance therapy in patients with newly-diagnosed, BRCA-positive advanced ovarian cancer who achieved a complete or partial response to standard frontline platinum-based chemotherapy.