Pharmacology update from ONS 2019

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Published: 8 May 2019
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Teresa Knoop - Vanderbilt Ingram Cancer Center, Brentwood, USA

Teresa Knoop speaks to ecancer at ONS 2019 about newly FDA approved drugs from 2018 and 2019 thus far, as well as previously approved drugs with new indications.

She highlights some of the trends she has seen from this period - such as biosimilars, immunology, molecularly targeted therapies, cellular agents, radiopharmaceuticals and tumour agnostic drugs.

Teresa offers advice to oncology nurses who may feel overwhelmed by the large number of newly approved drugs each year, including learning about generic naming.

My presentation on Sunday is called The Pharmacology Update and in the pharmacology update we will be reviewing all of the FDA approved drugs that have been approved in the last year and a half, so all of 2018 and thus far in 2019.

What new treatments do you think it’s important for nurses to be aware of?

There are many treatments nurses should be aware of and nurses often feel overwhelmed in the sheer number of treatments that get FDA approved every year. I did a similar lecture in 2004 and we talked about three drugs; in contrast, on Sunday I will be talking about 21 new drugs that have received FDA approval in just a year and five months. So that’s pretty phenomenal. Also what nurses have to keep in mind is not only are those the new drugs that are coming out of the clinical trial results but there are also FDA approved drugs that are gaining new indications. For example, in that year and a half there are about 23 drugs that had already had FDA approval for an indication but they got 40 new indications. So, for a nurse that’s about 61 new drugs coming at them per year and it is overwhelming to most nurses to try to figure out how to keep up, how to really know what these new drugs are and keep a handle on those. In that light, in this presentation we are actually going to do a kind of global view of these new drugs and talk a lot about generic naming of the drugs and how that gives the nurse some indication as to what the drug does, whether it’s oral, whether it’s IV or sub-cue, and really try to help nurses look at these in more of a classification light than each individual drug.

How can nurses deal with this overwhelming amount of new information?

We’ll talk about trends, there are certain trends that stand out in this year and a half. Some of those trends are the advent of biosimilar agents. Biosimilars are certainly getting FDA approval more and more frequently and biosimilars are biologic products that are approved based on a reference product that has already been FDA approved. Those biologics are more cost-effective to be given and they have to have the same safety profile, the same efficacy profile but certainly our nurses need to be aware of that trend, of the biosimilar trend. There are other trends – immunology is a trend that is definitely here to stay in cancer care and the use of molecularly targeted drugs is here to stay. One of the trends we’re seeing with this is that we are seeing where we may have seen some of these drugs used in the metastatic setting we’re now seeing these drugs used in maintenance therapies which means patients could be on these for years. We also are seeing these drugs used in adjuvant and neoadjuvant settings so really for a nurse to grasp that it’s not just in the metastatic setting that we’re seeing these drugs used.

Certainly one of the most historic new treatments that we’ve had in the past year and a half have been the advent of the cellular agents. So the agents where you take the patient’s own cells and actually genetically engineer them to place back into the patient and treat the patient’s cancer. That has given some phenomenal results, there are many clinical trials being conducted and not just in the hematologic setting where we see the agents now but also in the solid tumour setting we’re seeing many clinical trials with cellular therapy. So that’s another trend we’re seeing.

We’re seeing trends of radiolabelled pharmaceuticals coming and we have two drugs we’ll be talking about in that arena. We also are seeing tumour agnostic drugs. Tumour agnostic drugs are drugs in which we don’t give them based on the tumour histology but we give them based on the mutational status of the patient. So they could have any tumour histology – breast cancer, lung cancer, colon cancer – but if they have a certain mutation then that is a potential treatment option for patients.

Is there any treatment that you want to particularly highlight?

I’m personally excited about biosimilars where we’re seeing more of a cost-effective agent. We have to keep in mind the financial toxicity that our patients experience. With some of the new treatments, like the cellular therapies, they’re very, very expensive treatments. So I think we have a lot of challenges in helping our patients through the financial toxicity of those drugs.

Are there any new treatments you think are controversial?

I don’t think controversial is the word I would use but challenging is the word I would use. Certainly we had an exodus from inpatient to outpatient over the past few years. Many of the drugs that have been approved have been oral and patients are taking these at home. So those are challenging in that you want to be reassured in some way that those patients are being adherent to those drugs. So that is a challenge that’s not controversial but is something we, as nurses, have to recognise.

I’m seeing a trend because I work in clinical trials, a trend of many of these new agents when they are harnessing that immune system then they can cause very severe side effects acutely. I see that many of these drugs may have to be given in the inpatient setting. So it’s almost a trend back into the inpatient setting and certainly that’s not controversial but it challenges us in nursing to make sure we have both the nurse resources and the actual structural resources to care for those patients.

Do you have any useful tips for identifying drug classifications?

We’ll talk about that, the ‘ibs’, recognising the generic names of the drugs and helping you classify those agents. So we often use the ‘ibs’ and the ‘mabs’; we used to say ‘nibs’ and ‘mabs’ and that’s not really accurate anymore because we have lots of different agents that are not ‘nibs’. ‘Nibs’ are typically tyrosine kinase inhibitors and we’re seeing PARP inhibitors, we’re seeing PI3K inhibitors, we’re seeing lots and lots of different mutationally directed inhibitors. But looking at the ib and the name to say, ‘Okay, this is a small molecule,’ and recognising as a nurse that small molecules typically, although certainly not 100%, but typically are oral drugs so they are going to present you a challenge. Then looking at monoclonal naming, monoclonal naming is really fun for me because when you look at how drugs, how monoclonal antibodies, are named you can really figure out so much about the drug. You can figure out it is a monoclonal, you can figure out that it targets the circulatory system or the immune system or the tumour itself. You can figure out what type of monoclonal it is. So we’ll go over all of those different naming systems so that, again, it’s my approach to try to get the nurses to think more globally and really use those generic names as a way to direct the care. When they see a ‘mab’ then they’re going to go immediately, ‘Okay, I’m either going to be giving this drug IV and there is a potential for infusion reaction or subcutaneously.’ So we’ll be talking a lot about the naming of the drugs.

What is your take home message for oncology nurses?

My take home message is to try to stay focussed, not get too overwhelmed. We’re all about three clicks away from getting the details of any drug that we give now. But I do want to challenge nurses to look at it at a more global level. Really look, use that naming system, determine is this a small molecule, is this monoclonal, is this a cellular therapy. And really use that to your advantage to think about the drugs in terms of what does this mean to the patient, is this a precision medicine trial that we have to give back genomic information on before we even treat the patient. Because nurses will be really key in messaging those patients that, yes, it’s going to take a couple of weeks to get that genomic mutation information back but it could be really vital to giving you the right drug the first time.

So it’s a message of try to look at this in a more global fashion and not to get quite so overwhelmed. Again, we’re all a couple of clicks away from finding out those details of all of these drugs.