Weekly Roundup 12.12.14

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!

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