Pembrolizumab Plus Chemo Emerges as New Standard in Frontline Squamous NSCLC
June 3rd 2018Adding pembrolizumab to frontline carboplatin/paclitaxel or nab-paclitaxel reduced the risk of death by 36% compared with chemotherapy alone in patients with metastatic squamous non–small cell lung cancer.
Read More
Atezolizumab Plus Chemo Extends PFS in Frontline Squamous NSCLC
June 2nd 2018The addition of atezolizumab (Tecentriq) to frontline carboplatin and nab-paclitaxel (Abraxane) delayed the risk of progression or death by 29% compared with chemotherapy alone for patients with advanced squamous NSCLC.
Read More
Pomalidomide Triplet Extends PFS in Relapsed/Refractory Myeloma
June 2nd 2018Adding pomalidomide (Pomalyst) to bortezomib (Velcade) and low-dose dexamethasone reduced the risk of disease progression or death by 39% in patients with relapsed/refractory multiple myeloma with prior exposure to lenalidomide.
Read More
FDA Grants Frontline Eltrombopag Priority Review for Severe Aplastic Anemia
May 31st 2018The FDA has granted a priority review to a supplemental new drug application for eltrombopag (Promacta) for use in combination with standard immunosuppressive therapy as a frontline treatment for patients with severe aplastic anemia.
Read More
FDA Grants Crizotinib Breakthrough Designation for MET+ NSCLC and ALK+ ALCL
May 30th 2018The FDA has granted crizotinib a breakthrough therapy designation for the treatment of patients with metastatic non–small cell lung cancer with MET exon 14 alterations, and for use in patients with relapsed/refractory ALK+ anaplastic large cell lymphoma.
Read More
Durvalumab Improves Survival in Stage III NSCLC
May 25th 2018Durvalumab significantly improved overall survival versus placebo when used as a sequential treatment in patients with locally-advanced, unresectable non–small cell lung cancer who had not progressed following standard chemoradiotherapy, according to updated findings from the phase III PACIFIC trial.
Read More
Atezolizumab, Cobimetinib Combo Falls Short in Phase III mCRC Trial
May 10th 2018Combination therapy with the PD-L1 inhibitor atezolizumab and the MEK inhibitor cobimetinib failed to improve overall survival versus regorafenib in previously treated patients with locally advanced or metastatic colorectal cancer, according to topline findings from the phase III IMblaze370 study.
Read More
Olaparib Tablets Approved in Europe for Ovarian Cancer, Regardless of BRCA Status
May 9th 2018The European Commission has approved olaparib tablets (Lynparza) as a maintenance therapy for patients with platinum-sensitive relapsed high-grade, epithelial ovarian, fallopian tube or primary peritoneal cancer.
Read More
Quizartinib Improves Survival in FLT3-ITD+ Relapsed/Refractory AML
May 8th 2018Quizartinib improved overall survival compared with chemotherapy in patients with FLT3-ITD–positive relapsed/refractory acute myeloid leukemia after first-line treatment with or without hematopoietic stem cell transplantation, according to findings from the phase III QuANTUM-R study.
Read More
FDA Grants Frontline Atezolizumab Priority Review for NSCLC
May 7th 2018The FDA has granted a priority review to a supplemental biologics license application for atezolizumab for use in combination with bevacizumab, carboplatin, and paclitaxel for the first-line treatment of patients with metastatic nonsquamous non–small cell lung cancer.
Read More
FDA Approval Sought for Frontline Pembrolizumab Combo in Squamous NSCLC
May 3rd 2018A supplemental biologics license application has been submitted to the FDA for the use of pembrolizumab in combination with standard chemotherapy as a treatment for patients with metastatic squamous non–small cell lung cancer.
Read More
FDA Approves Tisagenlecleucel for Large B-Cell Lymphoma
May 2nd 2018The FDA has approved tisagenlecleucel (Kymriah) for use in adult patients with relapsed/refractory large B-cell lymphoma—including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma—after 2 or more lines of systemic therapy.
Read More
FDA Grants Priority Review to Cemiplimab in CSCC
April 30th 2018The FDA has granted a priority review to a biologics license application for the PD-1 inhibitor cemiplimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or patients with locally advanced CSCC who are not eligible for surgery.
Read More
European Panel Backs Carfilzomib Label Update in Myeloma
April 30th 2018The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended adding final overall survival data from the phase III ASPIRE trial to the label for carfilzomib for the treatment of patients with relapsed/refractory multiple myeloma.
Read More