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.
(Reporting by Dipika Jain in Bengaluru; Editing by Shounak Dasgupta)
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