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FDA Advisory Committee Unanimously Recommends Approval Of Gene Therapy For All

The FDA’s Oncologic Drugs Advisory Committee (ODAC) met to review the biologics license application for Novartis’ tisagenlecleucel-T (CTL-019), an intravenous CAR T therapy for treating pediatric and young adult patients (age 3-25) with relapsed/refractory (r/r) B-cell acute lymphoblastic leukemia (ALL). The panel voted unanimously (10-0) that the benefits outweigh the risks, sending a strong message to the FDA in favor of approval. The FDA PDUFA date is October 3, 2017.

FDA Public Meeting On Abuse-Deterrent Opioids

The FDA held a 2-day public workshop to discuss abuse-deterrent opioids and their impact on misuse, abuse, addiction, overdose, and death. The meeting, which focused on data and methods needed to evaluate abuse-deterrent formulations (ADFs) in the postmarket setting, came on the heels of the FDA’s decision that Endo’s Opana XR (oxycodone extended-release) should be withdrawn from the market and Endo’s agreement to do that.

Bulletin: CDC Report On Opioid Prescribing Trends

The Centers for Disease Control and Prevention reported on county-level trends in opioid prescribing from 2010-2015, showing prescription opioids continue to be a serious problem, with wide variations from county-to-county.

Transcatheter Valve Therapies (TVT)

Attendance at TVT was up ~20% this year. While there isn’t a lot going on with new transcatheter aortic valves beyond the move to intermediate-risk patients (and perhaps low-risk patients in the future), it is a busy space, with a multitude of other devices in development and generating excitement, including ~70 mitral valves, several tricuspid valves, embolic protection devices, and new imaging approaches. One of the themes running through the meeting was the need for a “full toolbox” of devices to treat patients.

American Urological Association (AUA)

Among the therapies discussed at AUA this year were: new therapies for benign prostatic hyperplasia, treatment of overactive bladder, prostate cancer tests and treatment, PD-1/L1 inhibitors for renal cell carcinoma and urothelial cancer, locally-delivered therapies for bladder and urothelial cancer, and robotic treatment of kidney stones.

FDA Advisory Committee Review Of Puma Biotechnology's Nerlynx (Neratinib) In Breast Cancer

The FDA’s Oncologic Drugs Advisory Committee voted 12-4 that the benefits of Puma Biotechnology’s Nerlynx (neratinib) outweigh the risks in HER2+ breast cancer patients who have completed treatment with Roche/Genentech’s Herceptin (trastuzumab). However, many panel members felt the label should be narrowed to limit the time between completion of Herceptin treatment and the start of Nerlynx.

American College Of Cardiology (ACC)

There was a lot of trial data at ACC, with a huge focus on hypercholesterolemia drugs, but also news on transcatheter aortic valve replacement (TAVR), bioresorbable stents, Novartis’ Entresto for heart failure, a new strategy for use of Abiomed’s Impella that could boost use, and more marketing studies for novel oral anticoagulants (NOACs).

American Academy Of Orthopaedic Surgeons (AAOS)

Orthopedic surgeons generally consider robotic surgery for total joints unnecessary and a marketing gimmick, but spine surgeons believe there could be real value for robotic navigation. n Orthopedic surgeons have been big prescribers of opioids, and AAOS has a big push to change that. One partial solution is intra-operative anesthesia, but doctors, if they use anything, generally prefer their own cocktail of drugs to Pacira Pharmaceuticals’ Exparel. n For the first time in decades, total joint replacement volume may decrease somewhat over the next 1-2 years despite the aging population, and there are a number of reasons for this. n CMS’s bundling project in orthopedics is raising interest in ways to lower cost – and that may increase interest in less expensive device options, including rep-less implants like those from Smith & Nephew/Syncera or lower-cost offerings from companies like United Orthopedics Corporation (UOC).