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.
Ibrutinib Combo Falls Short in Pancreatic Cancer
January 22nd 2019The frontline combination of ibrutinib (Imbruvica) and nab-paclitaxel (Abraxane)/gemcitabine did not show a statistically significant benefit in progression-free or overall survival versus placebo plus nab-paclitaxel/gemcitabine in patients with metastatic pancreatic cancer.
Olaratumab Falls Short in Phase III Soft Tissue Sarcoma Trial
January 18th 2019Olaratumab in combination with doxorubicin missed the phase III ANNOUNCE trial’s primary endpoint of overall survival and did not confirm a clinical benefit for patients with advanced or metastatic soft tissue sarcoma compared with standard doxorubicin.
FDA Issues Complete Response Letter for Sacituzumab Govitecan in TNBC
January 18th 2019The FDA has issued a complete response letter to Immunomedics regarding its biologics license application for sacituzumab govitecan as a treatment for patients with metastatic triple-negative breast cancer who have received at least 2 prior therapies, citing chemistry, manufacturing, and control matters.
FDA Issues Letter Regarding Safety Concerns With Paclitaxel-Coated Devices
January 18th 2019The FDA has issued a letter to healthcare providers that they should monitor patients with a type of peripheral arterial disease who have been treated with vascular balloons that were coated with paclitaxel or stents that release paclitaxel in the femoropopliteal artery in the leg.
Immunotherapy/Chemo Combinations Show Continued Benefit in NSCLC
January 17th 2019Several clinical trials have evaluated the addition of immunotherapy to standard chemotherapy in the frontline treatment of patients with advanced non–small cell lung cancer, all of which echo similar conclusions: these combinations are a mainstay in this population.
AHCT Consolidation Improves PFS in Younger Patients With Mantle Cell Lymphoma
January 17th 2019Within 6 months of receiving induction chemotherapy, consolidation treatment with autologous hematopoietic cell transplantation correlated with a significant improvement in progression-free survival in younger, fit patients with mantle cell lymphoma.
FDA Accepts sBLA for Frontline Atezolizumab Plus Carboplatin/Nab-Paclitaxel in Nonsquamous NSCLC
January 17th 2019The FDA has accepted a supplemental biologics license application for atezolizumab, carboplatin, and nab-paclitaxel as a first-line treatment for patients with metastatic nonsquamous non–small cell lung cancer.
ACCC 2018 Survey Finds Multiple Barriers to Cancer Program Growth
January 17th 2019The Association of Community Cancer Centers ninth annual Trending Now in Cancer Care survey reveals how cancer programs across the country are being impacted by pressure from turbulence in multiple sectors: payers, government, and industry.
FDA Grants Zanubrutinib Breakthrough Designation for Mantle Cell Lymphoma
January 15th 2019The FDA has granted the investigational BTK inhibitor zanubrutinib a breakthrough therapy designation for the treatment of adult patients with mantle cell lymphoma who have previously received at least 1 prior therapy.
Varlitinib Misses Primary Endpoint in Frontline Gastric Cancer Trial
January 14th 2019Frontline varlitinib (ASLAN001) added to mFOLFOX6 was not found to significantly reduce tumor size after 12 weeks of therapy compared with mFOLFOX6 alone in patients with HER1/HER2 co-expressing advanced or metastatic gastric cancer, missing the primary endpoint of a phase II study.