I gotta be fair to Dr. Richard Pazdur, the king of cancer drug approvals (or rejections) at the FDA. I have been sharply critical of him in the years past when we have watched niche, but seemingly useful, proposed new drugs go down in flames at his hands. I was worried. But now it seems a combination of better science, meticulous studies from drug companies, great support from patients and advocates, and yes, a kindler/gentler Dr. Pazdur and the FDA, has all led to quicker drug approvals – today in CLL/SLL and follicular lymphoma.
The latest news is about Gilead Science’s new drug – what we have been calling idelalisib and Gilead has named Zydelig®. We have many previous interviews that discuss its promise for patients including one about CLL and one about lymphoma. Now, in these conditions and one other, SLL, patients have an expanding array of treatment options. If one doesn’t work out for them or have lasting benefit, there is another treatment to try that works in a different way. And more are coming. Dr. Jeff Sharman outlined this for us months ago.
Happily, the FDA, with its grants of “breakthrough status” seems to be “with the program” in helping patients get quicker access to life-extending and life-saving new drugs. Thanks to them and to all of us who have put pressure on them to end being somewhat of a barrier in the past. Dr. Pazdur felt it was in name of protecting patient safety and ensuring effectiveness, but I haven’t always been so sure. [Editor's Note (07/28/14): On the heels of the recent approval of Zydelig (idelalisib), it was announced that the FDA has also expanded its approved use of Imbruvica (ibrutinib) to treat CLL.]
The bottom line is we blood cancer patients (I have two blood-related cancers, CLL and myelofibrosis) have expanding hope with approved new drugs, and others coming where the FDA sun may shine of them before long. For our friends in Europe, I pray the authorities there will soon follow suit and that the governments that have to pay for the drugs will write the checks. And, while we are discussing money, one point about cost is an aside here to Gilead and their peers in the pharmaceutical industry: thank you for your innovation, thank you for running the FDA gauntlet through approval, and yes, provide a return on investment to your shareholders. But don’t be greedy. Let’s work together, so everyone who needs breakthrough drugs can get them, and we don’t break the healthcare bank in the process.
By the way, as I write this, we have a CLL patient town meeting in two days here in Seattle. You can be sure the new approval will be discussed live in-person and on Twitter (#CLLSEA). Join us and look for a raft of new video discussions for these conditions coming at an accelerated pace. If the FDA can accelerate, so can Patient Power!
Send us your questions anytime at firstname.lastname@example.org.
Wishing you and your family the best of health!