Thursday, September 4, 2014

FDA Grants Keytruda® (Pembrolizumab) Approval For A Very Narrow Class Of Melanoma Patients -- Non-Responders To BMS's Yervoy®

This is good news for Merck, to be certain -- but the first approval window is needle thin -- in a very narrow class of patients. FDA has granted Merck approval for MK-3475 in end stage melanoma patients -- and only in those who are failing on other drugs, or have already failed to respond. The truth is that Merck probably is not ready to launch Keytruda® in very high lot/batch quantities, anyway -- so this will make only a bit of difference, in the near term. And, longer term, Merck needs to complete the ongoing clinical trials to finally establish Keytruda's place in treating other, higher burden, cancers.

The approval is great -- but with BMS close behind, and perhaps ahead, in the higher burden cancers -- the race remains wide open. In fact, BMS's Nivolumab/Opdivo® is on market in Japan, and with a whopping price tag ($184,000 per year) -- ever since mid August 2014. Here's Pete Loftus (of the Wall Street Journal) on it all:

. . . .The drug, which Merck plans to sell under the brand name Keytruda, is part of a long-anticipated wave of medicines that could transform cancer treatment and forge a large new market for pharmaceutical companies.

The Food and Drug Administration cleared the drug, pembrolizumab, for the treatment of a deadly form of skin cancer, melanoma. The approval followed a swift review of data from a relatively early-stage human trial — an unusual move reflecting the medical community's keen interest in pembrolizumab.

The infused drug is a new type of immunotherapy, a category of treatments that harness the immune system to fight cancer. It was approved for people who've failed to respond adequately to Yervoy, a Bristol-Myers Squibb Co. immunotherapy that works in a different fashion, and certain other drugs. . . .

Now it will get interesting -- likely with news every few days -- from both Whitehouse Station -- and BMS. Stay tuned, but I still think Opdivo® (Nivolumab -- BMS) will emerge as the overall winner. Most of Wall Street does, too.


Anonymous said...

BRISTOL-MYERS And Ono Sue Merck & Co., Claiming Pembrolizumab Infringes

Condor said...

Yep! Great Snag!

Will post on it -- including the complaint at law -- this afternoon.

Very entertaining reading; a long tough battle ahead, in the EU, Japan and the US -- on IP issues over Anti PD-1 inventions.

Thank you so much -- and Namaste!