Merck Says EMA Committee Adopted Two Positive Opinions For Expanding Use Of Cancer Drug Keytruda

European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted two positive opinions for Merck’s (MRK) blockbuster cancer drug Keytruda, the company said on Friday.

While one of the opinions recommends approval for a new subcutaneous route of administration and a new solution form for injection for Keytruda, the other recommends approval for the drug in treating locally advanced head and neck squamous cell carcinoma, Merck said.

The committee’s recommendations will now be reviewed by the European Commission. Final decisions on marketing authorization in the European Union, Iceland, Liechtenstein, and Norway are expected in the fourth quarter.

Shares of the company rose marginally in Friday’s pre-market session. On Stocktwits, retail sentiment about MRK stock stayed within the ‘bearish’ territory over the past 24 hours, while message volume fell from ‘normal’ to ‘low’ levels.

If approved for under-the-skin administration by a healthcare provider, the solution form for injection of Keytruda will be marketed in the European Union as Keytruda SC, the company said. It could be administered in one minute every three weeks or in two minutes every six weeks, offering an alternative to intravenous infusion.

“If approved, we believe KEYTRUDA SC has the potential to provide meaningful benefits to patients and providers in Europe because it can offer a shorter administration time compared to KEYTRUDA and the option to receive treatment in additional health care settings,” said Marjorie Green, senior vice president and head of oncology at Merck Research Laboratories. CHMP’s positive opinion applies to all Keytruda indications approved for adult patients in Europe.

An application seeking approval of subcutaneous Keytruda is currently under review in the U.S. as well. The U.S. Food and Drug Administration is expected to decide on the application by September 23.

The second CHMP opinion recommends approval of Keytruda as treatment of resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC). Head and neck cancer describes several different tumors that develop in or around the throat, larynx, nose, sinuses, and mouth. It is estimated that there were more than 947,200 new cases of head and neck cancer diagnosed globally and more than 482,400 deaths from the disease in 2022, Merck said.

Keytruda is Merck’s best-selling drug. In the second quarter, the company reported sales of $8 billion from Keytruda, representing a 9% year-over-year growth.

MRK stock is down 18% this year and approximately 30% over the past 12 months. 

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