The Food and Drug Administration is due to make an approval decision on injectable Keytruda by mid-September in a move that could bolster Merck's biggest franchise and downtrodden Merck stock.
Intravenous Keytruda is approved for 41 different cancer types in the U.S. By Sept. 23, the agency could approve an under-the-skin — or subcutaneous — injection version of Keytruda that cuts treatment time roughly in half. Merck is seeking approval for every condition in which Keytruda is already delivered with an intravenous infusion.
The decision would breathe new life into the Keytruda franchise, which dominated about 46% of Merck's sales last year. The intravenous version of Keytruda is set to begin losing patent protection in 2028. Subcutaneous Keytruda would be protected by an entirely new patent.
But that's not what excites Merck executive Marjorie Green the most. Green is the company's senior vice president and head of oncology global clinical development. In a previous role, Green cared for breast cancer patients. The time a patient isn't sitting at the doctor's office or in an infusion center is "incredibly valuable," she said.
"I think about these women who had breast cancer; after they have their surgery their ports can be removed. They don't necessarily need to maintain that kind of intravenous access," she told Investor's Business Daily. "These are patients (for whom subcutaneous shots) give them more freedom of not having the hardware — that visible reminder — of what they're going through."
Merck Stock: Focus On Bread-And-Butter Keytruda
Keytruda is easily Merck's biggest moneymaker, bringing in a whopping $29.5 billion in sales last year.
To put that in perspective, sales of Keytruda in 2024 were bigger than the sales of all of Gilead Sciences' products in the same year.
Keytruda also topped the sales of Regeneron Pharmaceuticals and Vertex Pharmaceuticals across all their products — combined.
But analysts are calling for Keytruda sales to decline starting in 2028, according to FactSet. It's possible subcutaneous Keytruda could reverse that.
Subcutaneous Keytruda uses a substance called berahyaluronidase alfa to rid fibrotic tissues from under the skin, allowing the body to absorb the drug faster. It takes two minutes to administer the under-the-skin shot vs. 30 minutes for the intravenous infusion.
When it comes to time in the chair — which involves setup and administration by a health care professional — subcutaneous Keytruda cuts down on administration time by 49.7%. Patients spend an average of 59 minutes in the chair when receiving under-the-skin Keytruda with chemotherapy, according to Merck's recent Phase 3 study. That compares to 117.2 minutes for the traditional IV Keytruda plus chemo.
Will Patients Switch To Subcutaneous Keytruda?
Green expects 30% to 40% of patients to switch from intravenous Keytruda to the under-the-skin shot, if approved. She acknowledges that's a hard figure to predict, and some patients will decide to stick with the IV formulation.
If approved, Merck will look at the two products as interchangeable, Green said. She declined to say whether Merck will begin using subcutaneous Keytruda in its clinical studies moving forward.
But she expressed excitement about the innovation with Keytruda.
"People get excited about the innovations that we make with our novel drugs," she said. "This is novel and it's innovative (in) a different way. It's improving the patient experience. So, I get equally as excited about this as I do our new therapies."
The news could also bolster Merck stock, which has underperformed the Medical-Ethical Drugs industry group. While Merck shares have lost 12% this year, the pharma industry group has risen almost 3%. Merck stock dipped a fraction on Thursday, ending the regular session at 87.60.
Follow Allison Gatlin on X/Twitter at @AGatlin_IBD.
