Skip to content

Merck Keytruda wins FDA nod to treat blood cancer

March 14, 2017

Merck & Co Inc said on Tuesday it had got a nod from the U.S. Food and Drug Administration for its already-approved immunotherapy drug Keytruda as a treatment for a type of blood cancer.

The nod from the FDA marks the first approval of the treatment for blood cancer. Keytruda is already approved for treating lung, head and neck cancers, among others.

The drug, administered intravenously, has been approved for use in adults at a fixed dose of 200 mg and in children at a dose of 2 mg/kg for refractory classical Hodgkin lymphoma, a type of cancer that starts in white blood cells. [nBw2FX4NYa]

The drug was approved under the FDA’s accelerated approval program which allows for quicker approval of drugs that fill an unmet medical need.

When a drugmaker wins accelerated approval, the company must provide further evidence of the drug’s benefit to satisfy the regulator, failing which the approval can be revoked.


From → Uncategorized

Leave a Comment

Leave a Reply

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

You are commenting using your 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

%d bloggers like this: