F.D.A. regulations have slowed progress toward curing cancer. Rather than reduce regulations, the head of the F.D.A. redefines “progress” as occurring when a new drug increases average lifespan by a mere three months.
(p. D3) Was there a moment when you realized a new era had begun?
It was a gradual thing. I wish I could say I had an “a-ha” moment.
I remember though, one of our first approvals of a PD-1 drug (a drug that unleashes the immune system to fight cancer). A division director sent me an email with a survival curve for patients in a study. It was a Friday afternoon. I saw it and I nearly fell off my seat. It was such a positive study for these patients with squamous cell lung cancer. They lived an average of six months with standard chemotherapy. With the new drug they lived 9.2 months.
I called the division director and said, “What are we going to do to expedite this?”
We had to get a submission from the drug company and that can take several months. Sometimes it takes six months and sometimes up to a year because of the voluminous amount of material that must be provided.
We got the submission in a couple of months. Nivolumab was approved in March of 2015.
It was a major therapeutic advance. These were people who heretofore had few therapeutic options.
. . .
. . ., my regret? I won’t be here in 2049, my presumed 50th F.D.A. anniversary.
I would love to see what oncology looks like given the rapid changes in the past 25 years. Hang on tight. The velocity of innovation will only increase.
For the full interview see:
(Note: ellipses added.)
(Note: the online version of the interview has the date Nov. 8, 2024, and has the title “He’s the F.D.A.’s Cancer Chief, Not a Fortune Teller.” The question is from the interviewer Gina Kolata. The rest of the words are quoted from the answers of Dr. Richard Pazdur.)