The FDA and My Daughter’s Death From Cancer

May 14, 2026

By Laurie Hays, May 14th, 2026 | From: The Wall Street Journal

My 33-year-old daughter died in 2022 from metastatic melanoma, which had spread throughout her body and taken over her brilliant brain. Claire Hays Montaigne, a new mother and a physician, lived heroically for two years with her cancer as we and her doctors scoured the globe for a breakthrough drug. Her hopes of survival dashed, Claire didn’t complain—except for one time.

After she emerged from a grueling two-week stint in the hospital, I told her that she looked beautiful despite everything. In tears, she blurted: “How can you say that? Do you understand what’s going on? I would do anything to get cured.”

Young women show a higher rate of melanoma, often diagnosed during pregnancy. One reason might be that the mother’s immune system is adjusting to protect the baby. There’s a lot we don’t know, but we do know that metastatic melanoma causes a brutal death. Every opportunity to cure it is worth pursuing.

I’ve been reading with horror about the Food and Drug Administration’s recent rejection of Replimune RP1 injection, one of the most promising drugs to fight metastatic melanoma in recent years. As a result of this decision, thousands of desperate patients have lost a chance at being among the one-third who have failed other courses of treatment and have already benefited from the drug in trials.

Numerous journalists, led by the Journal’s Allysia Finley, quote leading oncologists decrying the absurd and dysfunctional process that led to the FDA’s decision. Under the leadership of Marty Makary, who resigned this week under pressure from President Trump, the FDA twice moved the goalposts for approving Replimune RP1. One new requirement asked for an inhumane placebo control group, to which no physician could agree.

Mr. Trump reportedly lost patience with Dr. Makary and his deputy Vinay Prasad, who had been fired once already, for stalling on the approval of fruit-flavored vapes—no joke. But perhaps the FDA can revisit Replimune RP1. Replimune Group stock, which plunged after the rejection, rose with the news of Dr. Makary’s departure.

Time is of the essence. Replimune Group, a small biotech firm in Woburn, Mass., has laid off 60% of its workforce and is concentrating its limited resources on a treatment for an ocular uveal melanoma, a rare but also deadly form of the cancer.

Claire wouldn’t have benefited from Replimune RP1. A life-threatening brain swelling she experienced in response to her early immunotherapy would have made her ineligible for the treatment. I can only hope that Replimune RP1 will be approved and save other lives so they might be spared the suffering that Claire and our family endured.

On a FaceTime call shortly before July 4, 2020, Claire told us her melanoma—first treated five years before—was back. Claire and her family lived across the country. Because of Covid restrictions we had seen the 6-week-old baby only on video. My husband and I eagerly answered my cell, expecting another joyful visit with our granddaughter.

Instead, the camera zoomed in on Claire and her husband, Matt. They had tears in their eyes. Claire held the baby on her lap. In medical school, Claire had a small melanoma removed from the back of her arm. She was carefully monitored for a recurrence. Unknown to her, the malignancy metastasized during her pregnancy. The stage 4 melanoma presented as a lump in her lymph nodes, under her arm. Another tumor was discovered in her shoulder bone.

“We need your help,” Claire said.

I struggled to regain my composure after the first shock wave pierced my heart. I told her not to worry. Within hours, Claire was in touch with some of the kindest top cancer minds in the country. They said this was a promising time for treating metastatic melanoma.

I grew hopeful. Claire knew there was no guarantee. But for a while she too had hope. She weaned Charlotte quickly and started immunotherapy, took care of her patients, rode her bicycle to work, and tried to live as normally as possible for the remainder of what turned out to be her too-short life.

Claire spent her final few weeks in a drug trial in Fayetteville, Ark., many miles from her home in Oregon. She started bleeding internally, then endured two surgeries to try to stop it. She suffered terribly, but would not give up. She called me to say, “I don’t know if this is the end of the road or not, but can you get down here and figure out how to get me home?”

I flew down immediately and found a medevac plane to fly her home to Portland. Back at Oregon Health and Science University Hospital, where she had done her training, was on the faculty and looked after her own patients, Claire wanted options. She didn’t want to die.

Two days before the end, Claire called a family meeting at her bedside. My husband held her then 2½-year-old daughter. Claire asked for advice on one last outlandish option that a doctor had offered up. It sounded awful, so we helped her decide to pass on it.

In her last months, Claire’s skin was so sensitive that I couldn’t hug her. When she died at home, where she had asked to be, I held her tightly and sobbed. Her neck was still warm. Then I realized for the first time that she had tumor lumps all over her body. Knowing Claire, to have said something about them to me would have been too scary for both of us.

Ms. Hays is a journalist who has led newsrooms at The Wall Street Journal and Bloomberg News.