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Post by Dave's Not Here Man on May 23, 2017 21:50:53 GMT -5
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Post by k9krap on May 23, 2017 22:21:39 GMT -5
This drug has been advertised for quite a while. It's just been approved?
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Post by Dave's Not Here Man on May 24, 2017 8:23:46 GMT -5
On September 4, 2014, the US Food and Drug Administration (FDA) approved pembrolizumab under the FDA Fast Track Development Program.[17] It is approved for use following treatment with ipilimumab, or after treatment with Ipilimumab and a BRAF inhibitor in advanced melanoma patients who carry a BRAF mutation.[18]
As of 2015, the only PDL-1 targeting drugs on the market were pembrolizumab and Bristol-Myers Squibb's Yervoy and Opdivo, and clinical developments in the class of drugs received coverage in the New York Times.[19]
By April 2016, Merck had applied for approval to market the drug in Japan and had signed an agreement with Taiho Pharmaceutical to co-promote it there.[20]
In July 2015, pembrolizumab received marketing approval in Europe.[3][21]
On October 2, 2015, the FDA approved pembrolizumab for the treatment of metastatic non-small cell lung cancer (NSCLC) in patients whose tumors express PD-L1 and who have failed treatment with other chemotherapeutic agents.[22]
In July 2016, the US FDA accepted for priority review an application for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) after a platinum-based chemotherapy,[23] and gave an accelerated approval on August 9, 2016.[24]
In August 2016, the FDA granted an accelerated approval to pembrolizumab (Keytruda) as a treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) ("regardless of PD-L1 staining") following progression on a platinum-based chemotherapy, based on objective response rates (ORR) in the phase Ib KEYNOTE-012 study.[24] Full approval depends on the results of the phase III KEYNOTE-040 study (NCT02252042), running until Jan 2017.[24]
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So it's been approved in the US to treat certain cancers. This new approval, as I read it, is to treat any type of cancer in people with certain genetics. Which is the first of it's kind (that's been approved).
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Post by bobathon on May 24, 2017 9:22:20 GMT -5
IIRC, drug manufacturers add new uses to their existing meds, to refresh the patent and supress competition.
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Post by Dave's Not Here Man on May 24, 2017 10:17:07 GMT -5
Sure they do. The system is also rigged that way to make it seem legit. The FDA being the main facilitator of that. But there is a system and it does kind of work when it works. As I've said 1000 times, the FDA is the FIRST department that gets shitcanned under President Hall, and replaced by a food and a drug agency, not both together. Did I just create more lobbyists or what?
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