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Biotech Stocks Facing FDA Decision In December 2021

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Merck
Merck

Merck & Co., Inc. (MRK) has sought FDA approval to use its blockbuster cancer drug Keytruda for yet another indication – this time, for the adjuvant treatment of adult and pediatric patients (12 years and older) with STAGE IIB or IIC melanoma following complete resection.

The regulatory decision on the proposed indication is expected on December 4.

Keytruda received its first approval in September 2014 for treatment of patients with advanced or unresectable melanoma who are no longer responding to other drugs. Since then, the drug has been approved for various indications like non-small cell lung cancer, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, triple-negative breast cancer, to name a few.

In 2020, the drug generated worldwide annual sales of $14.4 billion, up 20% over 2019. In the nine months ended Sep.30, 2021, sales of Keytruda was $12.61 billion compared to $10.4 billion in the year-ago period.

MRK closed Friday’s trading at $79.16, down 3.79%.