The first frost on the pumpkin is not far away. The garden is beyond tired and leaves are filling the gutters. I find myself craving comfort foods and am anxious for that first fire in the fireplace. Time marches on, and so do we. Here is a bit of what happened this week:
- Second CAR-T Approval – During what has most certainly been an important year in new approvals in oncology, this week FDA announced another CAR-T therapy approval (chimeric antigen receptor T-Cell therapy). CAR-T treatments take human cells and re-train them to fight cancer. The new treatment – Yescarta (axicabtagene ciloeucel) – is indicated to treat adults with certain types of large B-cell lympohoma, the most common form of non-Hodgkin lymphoma, accounting for 3 out of 5 cases. In the FDA press release, Commissioner Gottlieb noted that the approval continues “the momentum of this promising new area of medicine” and re-stated the commitment of the agency to expedite such therapies and signaled that a new and comprehensive policy will be forthcoming to outline support for cell-based regenerative medicine. As noted in the posting on Wednesday, it also continues the momentum of new cancer therapies approved this year. Administration of the therapy will take place through hospitals that have undergone certification and training. Yescarta was designated by FDA as having Breakthrough Therapy status, had Priority Review and is an Orphan Drug. You can find the company release, which among other things contains information about a Patient Assistance Program, here.
- FDA, REMS and Opioids – In 2013, the HHS Office of the Inspector General (OIG) issued a report that criticized FDA’s oversight of REMS programs (Risk Evaluation and Mitigation Strategies) that are put into place when drugs are approved in order to shore up safe use. Now the OIG has scheduled a new investigation that is specific to the REMS programs of FDA approved opioids. The analysis will focus on how FDA determined the need for REMS programs for products as well as examine the extent to which the agency has monitored the implementation of the programs by companies to mitigate abuse. The fact that such an investigation is underway may pave the way for enhanced attention to these programs by FDA prior to the report coming out.
That’s it for me this week folks, Have a great weekend!
Upcoming Events to Keep an Eye on This Week
- Joint Meeting of Psychopharmacologic Drugs AdComm with Drug Safety and Risk Management – On October 31st to discuss NDA for new treatment for opioid dependence. Meeting again on November 1 to discuss a second NDA for the same indication.
- House Energy and Commerce, Subcommittee on Health Hearing – Examining HHS’s Public Health Preparedness for and Response to the 2017 Hurricane Season to be held on October 24 – including among others, testimony from Commissioner Gottlieb.
Regulatory Developments in Pharma/Biotech/Devices
- EMDAC gives 16-0-1 Vote to Recommend Approval of Type 2 Treatment
- FDA is looking for nominations for Advisory Committee openings
Photograph by Lynne Bertram, Woodstock, Vermont