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Regeneron Approved by FDA for Use After COVID-19 Exposure

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Published on August 13, 2021

New FDA Approval Protects Immunocompromised Individuals

Follow along as Patient Power advisor and CLL specialist Nitin Jain, MD, of the University of Texas MD Anderson Cancer Center, explains what the new FDA approval of Regeneron means for patients with a compromised immune system. Dr. Jain also discusses whether patients should get a COVID-19 booster shot — an evolving story.

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Transcript | Regeneron Approved by FDA for Use After COVID-19 Exposure

Andrew Schorr: Hello. It's Andrew Schorr with Patient Power, today on the road in San Luis Obispo, California, on the coast. Joining me from Houston, Texas and the University of Texas MD Anderson Cancer Center is Dr. Nitin Jain, who is a CLL specialist. And he is talking to us about some of the most current information related to COVID and immunocompromised patients like me. So, first of all, welcome back to Patient Power.

Dr. Jain: Yeah. Delighted to be here Andrew.

Andrew Schorr: Okay. So, we've just had new information from the FDA authorizing sort of expanded use of a monoclonal antibody, Regeneron, for people not yet diagnosed with COVID, but where they've been exposed.

Dr. Jain: Right.

Andrew Schorr: So what's your take on this? Because obviously we worry. So how are you viewing this?

What Type of Treatment is Regeneron? How Can it Protect Immunocompromised Individuals?

Dr. Jain: Yeah, monoclonal antibodies against COVID have been around since last year and there are different companies making it. Regeneron is one, Lilly is one, and they were used up until now where patients who have active COVID. So, you are diagnosed with COVID and then you can potentially get these antibodies in order to decrease the intensity, the severity of COVID. But recently, what FDA announced was the expanded news of particularly the Regeneron antibody, where if you're an immunocompromised person, which means a patient with cancer, patient with CLL, patient with other immune disorders and you are exposed to another individual who has COVID and you don't have the symptoms yet, but you are exposed to another individual. So in that case, the FDA is saying that you can ask your doctor or discuss with the doctor and you could potentially get the Regeneron monoclonal antibody to prevent you from getting the actual COVID infection.

So in fact, this recommendation is based on a randomized trial where half of the patients were given this antibody and half of the patients were not given this antibody and these patients were exposed and they were immunocompromised. And what they found was that close to 80% of the patients had decreased or not developing COVID after getting the antibody. So, it appears to be a very effective approach. And I think, this just happened yesterday or a few days ago that the FDA expanded these guidelines. So, I think parenting will be that if you are in this situation as a patient who is exposed to someone with COVID or has a family member who has COVID and you're living in the same household, I think that's a very pertinent issue. And then I think this monoclonal antibody formulation arc is now available for use.

Andrew Schorr: Okay. And so that results in communication between you and your doctor or the nurse at the clinic. So, if I find out that someone in my family, maybe somebody lives in my household has been diagnosed with COVID and I'm immunocompromised, it's pretty scary. What should I do?

What Should an Immunocompromised Person Do if They Are Exposed to COVID-19?

Dr. Jain: Yeah. So, I think that the best thing or the first thing will be to talk to your cancer doctor or whoever is your primary doctor that you're involved with, and this is a brand-new thing that just came out of the FDA. So, I think you should talk to your doctor that this is now available. And I would think that any hospital, any major hospital where this antibody is available for administration to patients, once you meet the criteria, which again, if you're immunocompromised, you have been exposed, then you should be able to access this antibody either through your primary care doctor or your cancer doctor or maybe the infectious disease doctor. But I think the first step will be to talk to your oncologist, or if you have other immune disorders, talk to your primary care doctor, whoever is managing you.

Andrew Schorr: Just to understand, a monoclonal antibody, this isn't infused therapy, right? So, whether it's in the emergency room or wherever, but it's outpatient, but you're going to get poked.

Dr. Jain: Right.

Andrew Schorr: And it's going to be administered to you, IV.

Dr. Jain: Correct. Yes.

Andrew Schorr: Okay. I want to ask you about one other thing that's very current in the news and that is about boosters. So, every day, I look in the newspaper and so now France, Germany, a lot of places, for immunocompromised patients, [are] giving yet another shot.

Dr. Jain: Right.

Andrew Schorr: But that hasn't happened yet in the U.S., what's your view of it? Because I know even these other countries that have authorized it have said, "Well, we don't really have the data, but we're going to do it."

What Are Your Thoughts on a COVID-19 Vaccine Booster for Cancer Patients?

Dr. Jain: All right. Yes. This is becoming a very timely and pertinent issue because we have patients with CLL, multiple myeloma, and some other diseases where studies have shown that if you get two doses of the standard Pfizer or Moderna vaccine or for example, Johnson and Johnson, a lot of patients are not mounting the immune response. So, the next question comes, can you give a booster, a third shot to boost their immune response? So, some of the data is starting to emerge. There was data from France in terms of the kidney transplant patients, where they did the third vaccination. And they found that that was effective in almost 50% of the patients they gave the third vaccination. But the data in terms of the leukemia, the blood cancer, it's really not out there yet.

So I do think that this is now being studied in clinical trials. So, there are clinical trials, which are, I believe, are going to happen in NIH and also through in New York area where they're going to get people in a clinical trial perspective and study it to see if the third chart would improve or lead to positive antibodies against COVID. So that I think is important to do. But at the same time, I believe CDC, FDA, all these groups are looking at the current data, as well as the Delta variant that is coming along to really see whether they should go ahead with possibly approving for booster vaccinations. Again, this is a very evolving field. So, what we're discussing today may not be valid a few days down the line, or a week down the line, but, but certainly the clinical trials are coming along and then hopefully there'll be some guidance from the FDA and CDC in this regard.

Andrew Schorr: One last thing about it. And we were talking to the Chief Medical Officer of Leukemia and Lymphoma Society. She said, because we don't have the data, not only do we not know to what extent it's helpful, but we don't know if it's harmful.

Dr. Jain: Right. Yeah. So, I think the data is really important. And as I said, I do know that clinical trials are about to happen in the United States. I think those trials and I'm assured that there's other trials happening in other countries as well about the booster vaccination. So, I think once we have those results out, hopefully soon, maybe in the next month or two months, then we'll know more about if this is a valid strategy, what side effects patients are having with a third shot? I think those things are important.

Andrew Schorr: Okay. Well, we've covered a lot of ground and of course this is sort of a moving target.

Dr. Jain: Right.

Andrew Schorr: So monoclonal antibody, not yet diagnosed, but worried that you've been exposed. Talk to your doctor.

Dr. Jain: Yes.

Andrew Schorr: The question about booster shots is evolving and all of us who are immunocompromised are going to listen carefully.

Dr. Jain: Yes.

Andrew Schorr: So hopefully we have a safe situation that continues as we go forward. Thank you for being our partner in all this, Dr. Jain, appreciate it. All right. I'm Andrew Schorr. And remember, knowledge and communication with your doctor as this information unfolds is so important. Remember, knowledge can be the best medicine of all.

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