February 3, 2016
According to a recent study in the Journal of the National Cancer Institute. Meanwhile, 85 percent of cancer patients in one survey were unaware that participation in a trial was even an option. This gap is hurting efforts to bring new therapies to patients who need it most. In World Cancer Day 2016, Celgene look back at their efforts over the last year to support the search for innovative ways to increase patient participation in clinical trials.
January 22, 2016
European Commission (EC) has approved a Type II variation for ADCETRIS® (brentuximab vedotin) to include data on the retreatment of adult patients with relapsed or refractory (R/R) Hodgkin lymphoma or R/R systemic anaplastic large cell lymphoma (sALCL) who previously responded to ADCETRIS and who later relapse. The Type II variation is based on data from the Phase 2 SGN35-006 Part A study that demonstrated effective anti-tumor responses can be achieved in the majority of R/R Hodgkin lymphoma and sALCL patients with ADCETRIS retreatment. The safety and efficacy results from this trial were consistent with the positive profile demonstrated in the pivotal Phase 2 studies (SGN35-003 and SGN35-004).
January 11, 2016
In January 11, 2016 – Novartis announced that it is adding to its diverse and deep immuno-oncology pipeline through a strategic alliance and licensing agreement with Surface Oncology. The agreement gives Novartis access to four pre-clinical programs that target regulatory T cell populations, inhibitory cytokines, and immunosuppressive metabolites in the tumor microenvironment. These programs will be explored as monotherapies and in combination with other complementary therapies in Novartis’ immuno-oncology and targeted therapy portfolios.
January 11, 2016
Sanofi, who has been a major investor and strategic partner since Warp Drive’s inception in 2012, and Warp Drive have entered into a research collaboration and exclusive license focused on the development of drugs targeting important human oncogenes including RAS, which has one of the highest mutation rates in cancer.
January 5, 2016
Xofigo® (Radium-223 Dichloride) is a therapeutic alpha particle-emitting pharmaceutical with an anti-tumor effect on bone metastases. Radium-223 mimics calcium and selectively targets bone, specifically areas of bone metastases, by forming complexes with the bone mineral hydroxyapatite. Recent data include the first set of safety and efficacy findings of Xofigo re-treatment from a Phase II study of metastatic castration-resistant prostate cancer patients with bone metastases.
January 4, 2016
Merck KGaA, Darmstadt, Germany, Pfizer and Syndax will collaborate to investigate safety, tolerability and preliminary efficacy of avelumab and entinostat in advanced ovarian cancer. The clinical trial program for avelumab, JAVELIN, is an expansive international clinical trial program exploring the use of PD-L1 inhibition with avelumab to treat multiple types of cancer.
December 11, 2015
Roche got US Food and Drug Administration (FDA) approval to Alecensa® (alectinib) for the treatment of people with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) on December 11, 2015. The indication for Alecensa is approved under accelerated approval based on tumour response rate and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
November 30, 2015
Empliciti (elotuzumab) in combination with two other therapies to treat people with multiple myeloma who have received one to three prior medications. Empliciti approved by US FDA on November 30, 2015.
November 16, 2015
Janssen Biotech, Inc. launch Darzalex ® (daratumumab) is a human CD38-directed monoclonal antibody. Darzalex is specifically indicated for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent. Darzalex approved by US FDA on November 16, 2015.
November 10, 2015
Genentech launch a new drug Cotellic ® (cobimetinib) is specifically indicated for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib. Which is approved by US FDA on November 10, 2015.