20
Jun
2017
Tag: immuno-oncology
14
Jun
2017
Bionest
Towards a Universal Immuno-oncology Assay Predictive of Drug Response
We have written frequently about the growing importance of biomarkers and how diagnostics will increasingly play a dominant role in the way that therapeutics are prescribed and reimbursed. Immuno-oncology (IO) treatments in particular are expected to benefit from the availability of truly predictive biomarkers, based on the dramatic treatment gains they have achieved for a...
31
May
2017
Bionest
FDA Changes the Game: First Cancer Drug Approval Based on Biomarker
The U.S. Food and Drug Administration has issued its first drug approval to a treatment for patients with a specific genetic biomarker, rather than based on an initial tumor location, such as breast cancer. On May 23, the agency granted an accelerated approval to Merck’s Keytruda (pembrolizumab) for the treatment of adult and pediatric patients...
26
May
2017
Bionest
It’s ASCO Time Once Again!
ASCO is the largest annual gathering of the worldwide oncology community, and this year’s event takes place this coming weekend, from June 2-6 in Chicago, Illinois. About 10 days ago, the association released its program and a wide slate of abstracts that have given way to plenty of media reports and speculation about what other...
23
May
2017
Bionest
And They’re Off….. Watching the CAR-T Race
On March 29, Novartis announced that the US Food and Drug Administration had accepted the company’s BLA filings for CTL019 (tisagenlecleucel-T) for the treatment of pediatric and young adult patients with relapsed and refractory B-cell acute lymphoblastic leukemia (ALL). Two days later, Kite Pharma announced that they had completed the rolling submission for their own...
25
Apr
2017
Bionest
Win One/ Lose One: Latest Rulings in the IP Battles Over CRISPR/Cas9
On March 28, the latest round in the intellectual property battle over CRISPR/Cas9 ended with the European Patent Office (EPO) ruling in favor of the University of California / University of Vienna, the work of scientists Jennifer Doudna and Emmanuelle Charpentier, and licensee CRISPR Therapeutics. The EPO granted the University of California (UC) a wide-ranging...
17
Apr
2017
Bionest
Reflecting on AACR
The American Association for Cancer Research annual meeting is always a source of major news and discussion on the oncology research front, and the 2017 meeting held earlier this month was no exception. One area of particular interest was the encouraging data on long-term survival that is emerging for some patients treated with immuno-oncology...
5
Apr
2017
Bionest
PARP Inhibitors Chalk Up Impressive Gains in Ovarian Cancer Maintenance Therapy
On March 27, the FDA gave Tesaro a broad approval for its PARP inhibitor, niraparib, as maintenance therapy for patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer after a complete or partial response to platinum-based chemotherapy. The FDA decision came well in advance of the PDUFA date set for June 30, and...
2
Mar
2017
Bionest
Chan Zuckerberg Initiative Makes First Bio Research Awards
Last fall, the Chan Zuckerberg Initiative announced plans to invest $3 billion over 10 years in scientific efforts with an ambitious long-range aim to “cure, prevent or manage” all diseases. As a first part of that effort, they directed $600 million towards the establishment of the CZ Biohub in San Francisco’s Mission Bay neighborhood. This...
16
Jan
2017