Keytruda remains Merck’s top-selling drug, responsible for $14.4 billion of Merck’s $48 billion in sales in 2020.
DreamstimeThe Food and Drug Administration rejected Merck’s application to approve its popular cancer immunotherapy drug Keytruda for certain patients with high-risk, early-stage triple-negative breast cancer.
The decision came a month after an FDA advisory committee voted unanimously against approving the drug until more data was available from an ongoing trial.
“The FDA’s decision was expected and in line with the recent recommendation from the FDA’s Oncologic Drug Advisory Committee” to wait on more data expected in the third quarter of this year, wrote Mizuho analyst Mara Goldstein in a note out late Monday.
Shares of Merck (ticker: MRK) were down 0.1% in premarket trading on Tuesday. The stock is down 4.3% so far this year, and up 1.8% over the past 12 months.
Keytruda remains Merck’s top-selling drug, responsible for $14.4 billion of Merck’s $48 billion in sales in 2020.
The company had sought approval for Keytruda to treat high-risk early-stage triple-negative breast cancer patients in combination with chemotherapy as a preoperative treatment, and then alone after surgery, but faced opposition at an advisory committee meeting in February.
In an FDA briefing document issued before the meeting, the agency raised concerns about the design and results of a key study, and suggested the committee consider whether approval should be postponed until more data was available. The committee, in a 10-0 vote, agreed.
In a statement Monday night, Merck said that it was reviewing the letter it had received from the FDA, and would discuss next steps with the agency. It noted the rejection doesn’t affect approval of any other Keytruda indications, including another approval the drug has in a separate group of triple-negative breast cancer patients.
In a note late Monday, Cantor Fitzgerald analyst Louise Chen wrote that she expects the company to eventually receive approval in the indication. “We continue to believe there is a high probability that subsequent data can support approval,” she wrote. “Given the high unmet need in TNBC, we still believe there could be a role for checkpoint inhibitors in the early stage setting.”
The rejection comes weeks after Merck withdrew a Keytruda indication in certain patients with metastatic small-cell lung cancer as part of an industrywide review of the FDA of oncology drugs that received accelerated approval contingent on future successful trial results, which have yet to achieve those trial results. An FDA advisory committee meeting in late April is scheduled to consider that indication, among other indications of other similar cancer drugs from other companies.
A series of surprise FDA delays and rejections in recent weeks has spread concerns among investors of a stricter regulatory posture at the agency, though the latest Keytruda decision doesn’t fall into that category, as the rejection was widely expected.
Write to Josh Nathan-Kazis at josh.nathan-kazis@barrons.com
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