Game changing agent, Opdivo, on a threshold to change standard of care in squamous cell carcinoma of the head and neck (SCCHN)
According to Dr. Robert Ferris, who is vice chair for Clinical Operations, associate director for Translational Research, and co-leader of the Cancer Immunology Program at the University of Pittsburgh Cancer Institute, Nivolumab (Opdivo) is ready to become the new standard-of-care option for all platinum-refractory patients with head and neck cancer, as per the recent findings. The PD-L1 inhibitor has received a priority review designation by the FDA in July 2016 based on the CheckMate-141 study, as presented in the ASCO 2016 Annual Meeting.
Rucaparib receives Priority review designation from FDA for advanced BRCA–mutated ovarian cancer
FDA granted priority review status to rucaparib of Clovis Oncology for the patients who have undergone 2 or more platinum based therapy for treatment of BRCA-mutated ovarian cancer. FDA is also set to make a decision regarding the acceptance of NDA for this molecule, by going through the ARIEL clinical program conducted in females with advanced ovarian cancer. Treating women with germline or somatic BRCA mutations after 2 platinum based therapies with rucaparib has indicated a great step forward in its treatment.
Sunovion Pharmaceuticals set to buy Canada’s Cynapsus Therapeutics for about $624 million.
Sunovion Pharmaceuticals Inc, a unit of Japan’s Dainippon Sumitomo Pharma Co Ltd, has planned to buy Canada’s Cynapsus Therapeutics, according to recent reports. Sunovion will acquire Cynapsus’ drug candidate, APL-130277, which is currently in its phase three clinical trial stage. It is designed to be an easy to administer, sublingual thin film of apomorphine to manage OFF episodes associated with Parkinson’s disease.
Pharma company Insys marketed opioid drug at high-volume prescribers – lawsuit
Insys Therapeutics Inc. has been accused of deceptive marketing practices involving a cancer drug and using “sham” speaking events to target doctors known to frequently prescribe opioid drugs, in a lawsuit filed by State of Illinois. The lawsuit filed alleges that Insys did not market its drug Subsys, designed and approved to manage cancer pain, to oncologists but rather to doctors with a reputation for high-volume approval of opioid prescriptions.