I Said A Year And A Half Ago That Merck’s Ridaforolimus “Was Never Going To Be A Blockbuster”

As ABC is reporting, an FDA panel voted 13-1 against approving ridaforolimus, saying the side-effects — seen in about 60 percent of studied patients — outweighed the benefits, for this candidate conceived as maintenence therapy, for a relatively rare form of cancer.

Here’s that St. Patrick’s Day 2011 post of mine (with even earlier background, here).
From ABC.com, then — a bit:

. . . .The panel saw less potential for Merck’s ridaforolimus, which the company acquired through Ariad Pharmaceuticals Inc. The group voted 13-1 against the drug, saying its significant side effects — which affected 60 percent of patients — outweighed its benefits.

Merck & Co. Inc. of Whitehouse Station, N.J., submitted the drug as a maintenance therapy, meaning it would be used to help repress sarcoma of the bone and tissue in patients whose cancer is already in remission. Since such patients are healthier than patients with active disease, panelists said they wanted to see a more dramatic benefit to justify putting patients on a drug with major side effects. The FDA has only approved a handful of cancer drugs for maintenance use.

Company trials showed no survival benefit and a meager seven-week delay in disease progression compared with patients not taking the drug. . . .

So it goes.


Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google+ photo

You are commenting using your Google+ account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )


Connecting to %s