Christmas cards not addressed because they aren’t bought. Gifts aren’t wrapped because of the same reason. I am definitely naughty.
- FDA Expands Approval of Lilly’s Cyramza - The most common type of lung cancer, non-small cell lung cancer (NSCLC) saw a new treatment approved for use to treat it today when FDA announced it was expanding the approval of Cyramza. The drug will be used in patients where the tumor has grown during or following treatment with platinum based chemotherapy, and will be used in combination with another chemotherapy – docetaxel. Cyramza was approved in April for advanced stomach h cancer adenocarcinoma and had an expanded approval in November to treat patients with advanced gastric adenocarcinoma, along with paclitaxel.
- Garidsil 9 Approved To Prevent Cancer Caused by 5 Additional HPV Types – The agency announced this week that it was approving Gardisil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) for the prevention of certain diseases caused by nine types of Human Papillomavirus (HPV). Covering nine HPV types, five more HPV types than Gardasil (previously approved by the FDA), Gardasil 9 has the potential to prevent approximately 90 percent of cervical, vulvar, vaginal and anal cancers. The agency said that Gardasil 9 adds protection against five additional HPV types—31, 33, 45, 52 and 58— which cause approximately 20 percent of cervical cancers and are not covered by previously FDA-approved HPV vaccines.
- 2014 FDA Drug Approval Track Record – This week, FDA Commissioner Margaret Hamburg wrote on the FDA Voice blog an update on approvals of new drugs for 2014 and there were definitely some interesting notes. She stated that even with a few weeks left to go (and there are some PDUFA dates out there), that the agency has in 2014 approved 35 novel new drugs, compared to 27 in 2013. On top of that, something that has been highly noticeable this year is that many new approvals have been for orphan drugs and have been utilizing FDA’s pathways for enhanced approvals. In fact, this year there were 15 approvals in 2014 or drugs for rare diseases, breaking the previous record from 2012 when 13 such drugs were approved. Finally, 15 of the drugs approved this year have been first-in-class compounds. And we still have two weeks to go – though anyone with a PDUFA date that falls on December 26 should take note that President Obama declared that day a holiday for federal workers, so you may see your approval file in a little earlier.
That’s it for this naughty boy. Have a good weekend and I hope you get your shopping done!
Time has been in short supply, but having survived Thanksgiving – guests, cooking and eating and gearing up for the gearing down of the calendar year (and the beginning of longer days) and it is time for a little breather. It is that time of year when we all stop and think about the year that has just gone by, and the one that is about to come. And while doing so, noting a little bit of what happened this week out of FDA:
- First Drug Approved to Treat Polycythemia – FDA approved a new indication and use for Jakafi (ruxolitinib) for treating patients with a rare condition known as polycythemia vera – a chronic type of bone marrow disease that occurs when too many red blood cells are made in the bone marrow. This can lead to swelling of the spleen, bleeding problems and clots in veins and can put patients at increased risk of stroke or heart attack. The drug was evaluated under priority review which provides an expedited review of the application by the agency. And because it is a rare disease, the drug also received orphan product designation. Jakafi was approved in 2011 for other indications.
- New Approval to Treat Rare Leukemia – While Jakafi was approved to treat a condition where the none marrow makes too many red cells, FDA also approved Blyncyto (blinatumomab) to treat patients with Philadelphia chromosome-negative precursor B-cell acute lympoglastic leukemia (B-Cell ALL), which is a rapidly growing type of cancer in which the bone marrow makes too many immature white blood cells. The drug is a type of immunotherapy and is the first approved drug that uses T-cells to destroy leukemia cells and is intended for patients who did not respond to previous treatment. This also had priority review and orphan product status and was approved under FDA’s accelerated approval program.
- Final Rule on Pregnancy and Lactation Labeling Information - The agency announced that it was publishing a final rule that sets standards for how information about using medicines during pregnancy and breastfeeding is presented in a prescription drug/biologic product label. The new content and formatting requirements will provide a more consistent way to include relevant information on risk and benefit. The final rule can be found here and an FDA blog posting on the topic here and a draft guidance here.
That’s it for me this week. Have a wonderful weekend everyone.
We have just been through an election cycle and the 113th Congress is in lame duck session. We are about to move on to the new Congress in January 2015. Who did America elect and what is their position on key health care issues? Who among them are poised to be the next health care leaders in Congress?
There is the obvious political side of the implementation of the Affordable Care Act which is inevitably going to resurface, but there are also perennial issues at play as well – medical innovation, children’s health, mental health, Medicare, reproductive rights and veterans’ health. The makeup of the new member of the new Congress will be poised to perhaps sway things one way or another in the 114th.
Fortunately, colleagues at a sister agency – TogoRun – here in Washington have put together an overview of incoming members from a healthcare point of view. It is available for you to download here. The guide is informative and easy to use – assessing how the new members affect the Congress in the aggregate and also to see one individually close up assessing their health care specific background and positions. You can look at their background and their history associated with disease-specific issues as well as their professional associations in health care.
I would like to say I wrote this resource, but instead I am relegated to be an advocate for it. Check it out.
It is a lovely autumn in our nation’s capital – at least looking at the trees and the light. It is always remarkable how the light angles change and the sun will suddenly appear beneath clouds instead of over them to give us colorful beautiful sunsets. And in this busy, busy time of year, it is good to have a steady supply of lovely colors to remind us of how good it feels just to experience the moment rather than be caught up in the future or the past.
But here are a few moments from this past week for you to ponder in case you are challenged to stay in the moment:
- OPDP Issues Untitled Letter - In what has been a record-low year for Warning and Untitled Letters out of FDA’s Office of Prescription Drug Promotion (OPDP), a letter was posted this week – only the 9th of the year. The letter involved a sales aid where the agency found that while some risk information was included, all of the contraindications were omitted as well as other important risk information and reminded us that further risk information cannot be incorporated by reference. The agency also found the way in which the product was positioned for its uniqueness also suggested that the product was safer and more effective.
- Ups and Downs of ODAC – In a vote of 8-3, members of the Oncologic Drugs Advisory Committee recommended that FDA approve Triferic for the treatment of iron loss to maintain hemoglobin in patients with hemodialysis-dependent stage 5 chronic kidney disease. The vote of the committee is a recommendation which FDA may or may not follow. The PDUFA date for deciding on approval is January 24, 2015. On another note, the same panel voted down a proposed treatment – a pan-deacetylase (pan-DAC) inhibitor – for multiple myeloma 5-2.
FDA has been very quiet of late. No press releases this month. No speeches. No testimonies. And so that’s it for me this week. Have a good weekend everyone.