New Delhi: The Subject Expert Committee functioning under the Central Drugs Standard Control Organization (CDSCO) has granted approval for additional indications of Pembrolizumab (Keytruda) Injection 100 mg/4 ml, manufactured by MSD Pharmaceuticals, expanding its use for advanced cancers in India. However, the nod came with a condition that the firm should conduct a Phase IV study in India in these indications.

The recommendation was made after the drug maker MSD Pharmaceuticals presented the proposal for the grant of approval of the following additional indications of the drug Pembrolizumab Injection 100 mg/mL based on the safety and efficacy data generated from global clinical trials in these indications, along with the request for a local clinical trial waiver.

i. KEYTRUDA (pembroliz

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