Podcasts about xgeva

Here is information on the latest US FDA approvals, the week of March 4 – March 8, 2024 ·         ChatGPT4 in medical writing and editing—visit learnAMAstyle.com ·       Nascentmc.com for medical writing assistance for your company. Visit nascentmc.com/podcast for full show notes   - **OTC Glucose Monitor**: The FDA has approved the Dexcom Stelo Glucose Biosensor System for over-the-counter sale, a first for a continuous glucose monitor. Designed for people aged 18 and older not using insulin, it helps manage diabetes with oral medications or monitors the impact of diet and exercise on blood sugar levels. Scheduled for release in Summer 2024, the system offers a 15-day sensor wear time and does not alert users to low blood sugar episodes.   - **Semaglutide in CVD Risk**: The FDA has approved semaglutide (Wegovy) for reducing cardiovascular risk in adults with known heart disease who are overweight or obese, specifically targeting the reduction of major adverse cardiovascular events. This approval makes semaglutide the first weight-loss medication also indicated for preventing life-threatening cardiovascular events in patients with established cardiovascular disease and obesity or overweight.   - **Juvederm Additional Indication**: JUVÉDERM® VOLUMA® XC, a hyaluronic acid dermal filler, has received FDA approval for treating moderate to severe temple hollowing in adults over 21, marking it as the first HA filler for this purpose. With effects lasting up to 13 months, clinical studies show significant improvement and patient satisfaction with facial symmetry post-treatment. This approval highlights Allergan Aesthetics' commitment to innovation in aesthetic treatments.   - **Nivolumab in mUC**: The FDA approved nivolumab in combination with cisplatin and gemcitabine for first-line treatment of metastatic urothelial carcinoma, based on significant improvements in survival outcomes from the CHECKMATE-901 trial. This expands nivolumab's indications, which include treatments for melanoma and lung cancer, among others, demonstrating its broad applicability in cancer treatment.   - **Zanubrutinib in FL**: The FDA has granted accelerated approval to zanubrutinib and obinutuzumab for relapsed or refractory follicular lymphoma patients after two or more systemic therapies. This combination targets key pathways in B cell survival, offering a new treatment option for patients. Approval was based on the ROSEWOOD trial, highlighting significant patient outcome improvements.   - **Donanemab and Alzheimer's**: The FDA has postponed the decision on the approval of Eli Lilly's donanemab for Alzheimer's treatment to convene an advisory meeting for further examination of safety and efficacy data, indicating a significant delay. This reflects the complex nature of Alzheimer's drug approval and Eli Lilly's confidence in donanemab's potential benefits.   - **Tocilizumab Biosimilar**: Tyenne® (tocilizumab-aazg), the first FDA-approved biosimilar to Actemra® for various inflammatory diseases, is now available in both IV and subcutaneous formulations. This approval introduces a new treatment option for patients with conditions like rheumatoid arthritis and juvenile idiopathic arthritis, emphasizing advancements in biosimilar medications.   - **Denosumab Biosimilars**: The FDA approved Jubbonti and Wyost as interchangeable biosimilars to Prolia and Xgeva, respectively, marking a first for biosimilars targeting the RANKL inhibitor used in osteoporosis and cancer-related bone conditions. These approvals offer new treatment options for managing bone health, underlining the importance of biosimilar development in expanding patient care.   - **Clobetasol Propionate Eye Drops**: The FDA's approval of clobetasol propionate 0.05% eye drops for post-operative eye inflammation and pain introduces the first ophthalmic formulation of this corticosteroid and the first new steroid in ophthalmology in over 15 years. Developed using proprietary nanoparticle technology for twice-daily dosing, this approval offers a new option for effective pain and inflammation management post-eye surgery.

Over-the-counter birth control pill to be available in the coming weeks; first over-the-counter continuous glucose monitor to be available starting this summer; the 2024-2025 US influenza season vaccine will be trivalent; LSD granted Breakthrough Therapy for treatment of generalized anxiety disorder; interchangeable biosimilars to Prolia and Xgeva approved. 

PROSTATE PROS Series Finale On the last episode of the PROSTATE PROS podcast, Dr. Scholz and Liz recap important themes and talk about what’s new in prostate cancer, including Lutetium-177 and Orgovyx. Dr. Scholz: [00:03] We’re guiding you to treatment success and avoiding prostate cancer pitfalls. I’m your host, Dr. Mark Scholz. Liz: [00:09] And I’m your cohost, Liz Graves. Dr. Scholz: [00:13] Welcome to the PROSTATE PROS podcast. Liz: [00:15] We have a bit of a sad announcement to make, as this will be the last episode of the PROSTATE PROS podcast. Dr. Scholz and I have really enjoyed working on this project and we’ve covered so many important topics surrounding prostate cancer and men’s health. So for this last episode, we’re going to recap some important themes and talk about some promising new therapies. So Dr. Scholz, on our very first episode, we talked about how important it is to find the right treatment team. This is something that’s come up again and again and again. What are some tips you have for newly diagnosed men trying to find their doctors? Dr. Scholz: [00:53] I think what’s confusing is how much of the responsibility falls on the shoulders of patients. The prostate industry is a very powerful multi-billion dollar industry, and there is a lot happening really fast. When patients are diagnosed, they’re not in a thoughtful perspective, they’re in an action mode, they’re frightened. It is hard to sort out who to listen to and who to stay away from. This process can be aided by family members, primary care doctors, oncologists, and of course, online resources and books. I try to provide some of that information in the book, The Key to Prostate Cancer, but the process, if it was easy, we could give you one simple answer. It is not a simple process. Liz: [01:46] One thing that we’ve talked about is to get a quarterback. So this is a doctor that isn’t the treating doctor necessarily, but it’s someone that will oversee the treatment and work with the other teams of doctors. This is something I hear you doing Dr. Scholz, you’re always talking to other doctors about patients and kind of networking with them to make sure that the patient is getting the best care, even when they’re not in our office. Dr. Scholz: [02:12] I think the issue that you’re relating to is that many of these physicians have a conflict of interest. You’re asking them, what should I do? But they’re a surgeon or they’re a radiation doctor. And as a medical oncologist, I’m neither of the above. This is somewhat uncommon, but you can recruit your urologist or your radiation doctor to help you by explaining at the outset that, “you, sir, will not be my treating doctor, but I definitely need your aid and your assistance in picking the right doctor.” Liz: [02:43] Now you may be thinking that you have cancer and you don’t have time to see all these people, but as we’ve mentioned, prostate cancer is slow growing. So really taking that time to find the right doctor for you is crucial. Dr. Scholz: [02:56] Just yesterday, I saw a very sophisticated new patient who was feeling the rush job, the sense that the clock is ticking, and he did have a Gleason 9. We consider that the High-Risk category of prostate cancer. But, the idea that you have to make a decision within days or weeks is never substantiated by the literature and the science. Patients can take several months to sort out what they want to do. This sort of careful thoughtful process pays off in the long-term with better results. Liz: [03:29] So patients really need to take it under their control. One of the things is to educate themselves. In the past couple of years, there’s been a huge shift towards imaging. So we’ve had the approval of the PSMA PET scan and using 3T MP MRIs and color Doppler to help men diagnose their prostate cancer and watch it. Dr. Scholz: [03:51] What Elizabeth is referring to is that if you don’t have a clear picture of where the cancer is and whether it’s spread outside the gland, what part of the gland it’s located in, it’s not feasible to tailor treatment to the specific needs of the individual. Some men are fortunate enough to have prostate cancers residing on one side of their gland. This opens the door to something called focal therapy, enabling men to undergo treatment with less risk of erectile dysfunction. There were a lot of things we could have covered in this last podcast and the reminder that quality imaging and not only MRI and PSMA PET scans, but scans done at centers of excellence that are read by experts are going to help men be light years ahead in their selection of treatment, because they’ll have a clear picture of what they’re really treating. Liz: [04:43] So we’ve actually gotten emails from people all across the country saying, you know, my doctor’s never heard of the PSMA PET scan or my doctor doesn’t do 3T imaging. So it is really important that you take the time to educate yourself and bring these questions to your doctors. Finding the right treatment team and doing your due diligence to make sure you’re choosing the right treatment is all important because of where the prostate is located. Treatment related side effects can have damaging effects on quality of life. Because prostate cancer is so slow growing, hopefully you’ll have a very long life, so it’s important that that can be lived to the best of your ability. Dr. Scholz: [05:25] That’s so, so important. And these functions, sexual, urinary functions are something that people face every day of their life. In the hustle bustle to get treatment quickly, the fact that if the treatment is not done in an ideal way, that men can be left with permanent issues unnecessarily, certainly if there was no other option, we would live with these negative consequences. But, in most cases now with skillful care, these things can be avoided. Liz: [05:58] Over the past two years, Dr. Scholz and I have covered all the treatment options from active surveillance to surgery, radiation chemotherapy. These episodes will still be available even after the podcast ends, you can go back and re-listen and keep sharing with friends and educating yourself. Dr. Scholz: [06:16] One thing about this information provided in the podcast is not only the idea of which treatment is best and what kind of things to look out for, but the step by step process, the thinking process, the procedures, and how you can come to get the right doctors and the right treatment is implicit in the whole podcast system that we have provided. So you can also just learn from the thought process that leads to successful outcomes. Liz: [06:49] While there are a lot of challenges that newly diagnosed patients face, patients with advanced prostate cancer also are missing out on some tools like Xgeva and Prolia. Dr. Scholz: [07:01] These medicines are to help compensate for men who have disease that’s spread to their bones or men who’ve been on hormone treatment and the calcium is leaching out, a process called osteoporosis. The number of times this is overlooked and people coming to us for second opinions is really quite surprising, as they are FDA approved to help compensate for these problems. So simple second opinions can be so valuable for men, even if they have advanced disease. Liz: [07:35] As we segue into what’s coming up and what’s new in prostate cancer, we wanted to quickly mention that there are a lot of new drugs and things being tested for FDA approval through clinical trials. Clinical trials are a great way to get access to these new medications, if you have a specialist on your team who is constantly looking out for these and keeping tabs on what’s coming up. Dr. Scholz: [08:03] Every new medicine or treatment goes through a process of being researched. Once it’s validated as a treatment, it gets FDA approved. And then after that, it becomes commercialized and broadly available across the country. The things that succeed through that process are very valuable. And we’ll be talking about a Lutetium-177 and a new pill called Orgovyx. These medicines have been available, but now are commercially available. If your physician is not staying abreast of all the new developments, men who could benefit from these treatments will be denied access simply through unawareness. Liz: [08:43] Lutetium-177 is something that we’ve talked about on past podcasts. And it’s not even FDA approved yet, but you’ve actually had some patients who have had it, is that correct? Dr. Scholz: [08:57] Lutetium-177 a was purchased by a Novartis pharmaceuticals for $2 billion prior to all the testing being completed because all the preliminary data looks so favorable recently, they released the code for the large clinical trial that was performed confirming that it does prolong survival. This is a medicine that was evaluated in men with very advanced prostate cancer who had already had chemotherapy who had been on other powerful hormone treatments and they’d stopped working. The man who got treated with Lutetium-177 lived longer, statistically significantly longer, than the men who got an alternative, placebo-type approach. This medicine is well tolerated. It can cause some dryness of people’s mouths. It can lower blood counts a little bit, but it’s a simple injection every six weeks. And it is a potent treatment for men with advanced disease. It may even be a useful treatment for men with earlier stage disease. This will probably be commercially available within a year. Liz:  [10:05] To learn more about this medicine, we covered it in Episode 10, Don’t Reject Radiation.  So you can go back and listen to that.  At the end of 2020, there was a new FDA approval Orgovyx.  This is an oral anti-androgen, so it works kind of like a Lupron, but instead of it being an injection, it’s just a daily pill.  Dr. Scholz: [10:28] So how much do we really need a new pill? When if you could take an injection that lasts three to six months, and you don’t have to remember taking pills every day, but Orgovyx may have some other advantages when compared to head to head with Lupron and the other medicines like Lupron, such as Firmagon and Trelstar, Eligard, and Zoladex. These medicines all work by shutting down the production of testosterone in a man’s testicles. Orgovyx is interesting for two reasons. One is that the recovery of testosterone when treatment is stopped, seems to be much more predictable and consistent medicines like Lupron, and the others that I mentioned, can have a very protracted and prolonged effect even after they’re stopped, and it’s hard to predict when testosterone is going to return. Another thing that came out in Orgovyx trials was a lower incidence of cardiovascular complications. For years, I’ve made a strong argument that Lupron and other drugs do not cause cardiovascular problems directly, but indirectly in men who have a lot of weight gain, blood pressure goes up, blood sugars start to go out of control. Of course these things can lead to cardiovascular problems, but for some reason, in that randomized trial Orgovyx had a lower incidence of cardiovascular related issues. This is certainly an interesting and potential advantage for this medication. Liz:  [11:56] Technology and medicine around prostate cancer is improving almost daily.  And one of the things that’s really promising is immunotherapy.  We talked about this on Episode 9, The Intelligence of Immunotherapy, and we cover all sorts of different things that will benefit men with prostate cancer, like KEYTRUDA and OPDIVO YERVOY.  So if you’re interested in learning more about immunotherapy Episode 9 is a great place to start.  Making this podcast has been such a rewarding experience for Dr. Scholz and I, and we really hope that it’s helped you on your prostate cancer journey.  And we’ve left you with a little more education and knowledge and empowered you to take control of your prostate cancer diagnosis and spend time really learning about it and understanding, so you can have your medicine personalized to you.  You can find the right doctors, seek second opinions, and then take everything you’ve learned to spread awareness about prostate cancer.  Remember prostate cancer is a silent disease and it affects so many men and families and loved ones.  This really needs to be something that people are comfortable talking about.  So we hope our podcast has helped give you some points to talk about with your friends and family members and help them make those treatment decisions.   Dr. Scholz: [13:26] So Kaili, my business manager and myself are very grateful to Liz for all the hard work she’s done in compiling these episodes and helping us reach the things that really count. It’s been quite a bit of work along the way, which has been a delight to participate in for me. Liz, can you just share a couple of sentences of where you think you’re going to be going with your own professional career as you’re moving on? Liz: [13:51] Yes.  I am actually pursuing higher education to become a professional writer.  I am looking forward to it, but I’m definitely sad that I won’t be working with you and bringing this podcast to everyone.  I know I’ve had so much fun learning about prostate cancer and hopefully being able to help all of our listeners navigate this subject.  Again, these episodes have been archived, so you can go back and listen to all twenty-four of them on podcast.prostateoncology.com, or Apple Podcasts, SoundCloud, wherever you like to listen.  Another good tip is that the PCRI’s YouTube videos come out every week.  These are awesome videos that talk all about prostate cancer.  Dr. Scholz is a very frequent guest on there, so I would highly recommend you check that out.  You can find them at youtube.com/thePCRI.  Thank you for listening and supporting us.

Dr. Benjamin Levy, Mount Sinai Health Systems, compares zoledronic acid and denosumab, two agents used for treatment of bone metastases in lung cancer.

Dr. Benjamin Levy, Mount Sinai Health Systems, compares zoledronic acid and denosumab, two agents used for treatment of bone metastases in lung cancer.

Dr. Benjamin Levy, Mount Sinai Health Systems, compares zoledronic acid and denosumab, two agents used for treatment of bone metastases in lung cancer.

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