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.
Pembrolizumab Nears European Approval for HNSCC
July 31st 2018The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of pembrolizumab (Keytruda) for the treatment of adult patients with recurrent or metastatic head and neck squamous cell carcinoma who progressed following platinum-based chemotherapy and have a PD-L1 tumor proportion score ≥50%.
EU Panel Backs Frontline Pembrolizumab Combo for Nonsquamous NSCLC
July 30th 2018The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of frontline pembrolizumab (Keytruda) for use in combination with standard chemotherapy for patients with metastatic nonsquamous non–small cell lung cancer without EGFR or ALK mutations, regardless of PD-L1 expression.
Durvalumab Approaches EU Approval for Locally Advanced PD-L1+ NSCLC
July 27th 2018The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of durvalumab for the treatment of patients with locally advanced, unresectable stage III non–small cell lung cancer who have not progressed following chemoradiotherapy and whose tumors express PD-L1 on ≥1% of tumor cells.
Adjuvant Dabrafenib/Trametinib Nears European Approval for BRAF+ Melanoma
July 27th 2018The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of the combination of dabrafenib and trametinib for the adjuvant treatment of adult patients with BRAF V600E– or V600K–positive stage III melanoma following complete resection.
EU Panel Backs Frontline Daratumumab/VMP Combo for Multiple Myeloma
July 27th 2018The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of daratumumab in combination with bortezomib, melphalan, and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
Binimetinib/Encorafenib Combo Approaches European Approval for BRAF+ Melanoma
July 27th 2018The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of the combination of the BRAF inhibitor encorafenib and the MEK inhibitor binimetinib for the treatment of adult patients with BRAF V600–mutant unresectable or metastatic melanoma.
Langer Highlights the Impact of Chemoimmunotherapy in NSCLC
July 24th 2018Although impressive single-agent data have been seen with agents such as pembrolizumab (Keytruda) versus chemotherapy in a high–PD-L1 population, the combination of PD-L1 inhibitors and chemotherapy may prove to be beneficial in a broader group of patients.
Atezolizumab Regimen Extends PFS in Frontline Nonsquamous NSCLC
July 19th 2018Adding atezolizumab to pemetrexed and cisplatin or carboplatin in the frontline setting reduced the risk of disease progression or death versus chemotherapy alone in patients with advanced nonsquamous non–small cell lung cancer, according to findings from the phase III IMpower132 study.