All The Most Important Pharmaceutical News Stories Of The Week – October 2018 – Week # 3
Novartis analysis shows crizanlizumab (SEG101) increased the number of patients free of sickle cell pain crises vs placebo during SUSTAIN study
October 9, 2018
Results from a post hoc analysis of the Phase II SUSTAIN study of crizanlizumab, a humanized anti-P-selectin monoclonal antibody being investigated for the treatment of sickle cell disease (SCD), have been published in the American Journal of Hematology. The analysis showed that more patients treated with crizanlizumab did not experience a vaso-occlusive crisis (VOC) vs those treated with placebo (35.8% vs 16.9%), specifically patients with a history of 2-10 VOCs in the previous year.
Celltrion and Teva Announce FDA Oncologic Drugs Advisory Committee Recommends Approval of Celltrion BLA for CT-P10, a Proposed Rituximab Biosimilar
October 10, 2018
Celltrion, Inc. and Teva Pharmaceutical Industries Ltd. has announced that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee voted unanimously 16-0 to recommend approval of CT-P10, a proposed monoclonal antibody (mAb) biosimilar to Rituxan® (rituximab) for the treatment of adult patients in three proposed indications. The proposed indications are: (1) relapsed or refractory, low-grade or follicular, CD20-positive, B-cell Non-Hodgkin’s Lymphoma (NHL) as a single agent; (2) previously untreated follicular, CD20-positive, B-cell NHL in combination with first-line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy; and (3) non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone chemotherapy.
Novartis announces new data from the first direct head-to-head trial to demonstrate superior efficacy of Gilenya® over Copaxone® in patients with relapsing remitting multiple sclerosis
October 10, 2018
Novartis has announced topline results from the Phase IIIb ASSESS study, which evaluated the efficacy and safety of oral, once daily Gilenya (fingolimod) 0.5mg and 0.25mg versus once daily subcutaneous injections of Copaxone (glatiramer acetate) 20mg in patients with relapsing remitting multiple sclerosis (RRMS). The data show that Gilenya 0.5mg met its primary endpoint of significantly reducing the annualized relapse rate (ARR) compared to Copaxone. Treatment with Gilenya 0.5mg resulted in a 40.7% relative reduction in the rate of relapses over a period of one year, compared to Copaxone. Further initial findings showed adults taking Gilenya 0.25mg achieved a numerical risk reduction in relapses compared to the comparator, but did not reach statistical significance.
CRISPR Therapeutics and Vertex Announce FDA Has Lifted the Clinical Hold on the Investigational New Drug Application for CTX001 for the Treatment of Sickle Cell Disease
October 10, 2018
CRISPR Therapeutics, a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, and Vertex Pharmaceuticals Incorporated have announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold and accepted the Investigational New Drug application (IND) for CTX001 for the treatment of sickle cell disease (SCD). CTX001 is an investigational, autologous, gene-edited hematopoietic stem cell therapy for patients suffering from severe hemoglobinopathies.
Bristol-Myers Squibb and Compugen Announce Clinical Collaboration to Evaluate Therapeutic Regimen in Advanced Solid Tumors
October 11, 2018
Bristol-Myers Squibb Company and Compugen have announced the companies have entered into a clinical trial collaboration to evaluate the safety and tolerability of Compugen’s COM701, an investigational anti-PVRIG antibody, in combination with Bristol-Myers Squibb’s programmed death-1 (PD-1) immune checkpoint inhibitor Opdivo (nivolumab), in patients with advanced solid tumors. In conjunction with this collaboration, Bristol-Myers Squibb will make a $12 million equity investment in Compugen.
Bristol-Myers Squibb Announces Phase 3 CheckMate -331 Study Does Not Meet Primary Endpoint of Overall Survival with Opdivo Versus Chemotherapy in Patients with Previously Treated Relapsed Small Cell Lung Cancer
October 12, 2018
Bristol-Myers Squibb Company has announced topline results from the Phase 3 CheckMate -331 study evaluating Opdivo (nivolumab) versus the current standard of care, topotecan or amrubicin (where approved), in patients with small cell lung cancer (SCLC) who relapsed following platinum-based chemotherapy. The study did not meet its primary endpoint of overall survival (OS) with Opdivo versus chemotherapy. The safety profile of Opdivo in this trial was consistent with that observed in previously reported monotherapy studies involving patients with SCLC.
October 15, 2018
Roche has announced the global commercial launch of three new next-generation sequencing (NGS) AVENIO Tumor Tissue Analysis Kits – the AVENIO Tumor Tissue Targeted Kit, Expanded Kit and Surveillance Kit. The kits, which detect all four mutation classes in solid tumours, complement Roche’s NGS ctDNA kits for oncology research. The AVENIO research-use-only (RUO) portfolio of ready-to-use kits provides reagents and software needed for labs to determine the genomic characteristics of solid tumours through a single DNA workflow.
Roche’s Kadcyla reduced the risk of disease recurring in people with HER2-positive early breast cancer with residual disease after neoadjuvant treatment
October 15, 2018
Roche has announced the phase III KATHERINE study met its primary endpoint, showing Kadcyla® (trastuzumab emtansine) as a single agent significantly reduced the risk of disease recurrence or death (invasive disease-free survival, iDFS) compared to Herceptin® (trastuzumab) as an adjuvant (after surgery) treatment in people with HER2-positive early breast cancer (eBC) who have residual disease (pathological invasive residual disease in the breast and/or axillary nodes) present following neoadjuvant (before surgery) treatment. The safety profile of Kadcyla in the KATHERINE study was consistent with previous clinical trials and no new safety signals were identified.Top Pharma News of the Week – October 15th last edit: 2018-10-15T20:17:08+00:00 da