What are the new medicines for lung cancer (and how to get them

What are the new medicines for lung cancer (and how to get them Lung cancer is the leading cause of death in Poland, leading to about 21,000 deaths annually 1. Despite recent progress in treatments, many patients still face challenges. Among others, due to delays in access to state-of-the-art medicines. The good news is that lung cancer patients in Poland can access some of the newest, most advanced medicines in the world. Even if they are not yet approved or available locally. In this article, you’ll discover some of the latest breakthrough treatments for different types of lung cancer and how to get them in Poland. What are the newest immunotherapies for lung cancer in the world [2025]? In the past decade, immunotherapy has transformed lung cancer care – particularly for non-small cell lung cancer (NSCLC), though advances have also been made in treating small cell lung cancer (SCLC). These treatments help the immune system recognize and destroy cancer cells, improving survival and quality of life for many patients. Here are some of the latest approved lung cancer immunotherapies making an impact globally. #1: Imdelltra (tarlatamab) — for patients who have exhausted other options Imdelltra (tarlatamab) is an innovative immunotherapy for adults with advanced small cell lung cancer (SCLC) that has worsened despite previous platinum-based chemotherapy 2. Imdelltra is the first of a novel class of medicines called bispecific T-cell engagers. It is a type of targeted immunotherapy designed to direct immune cells to attack cancer more efficiently. The way it achieves that is by interacting with both the CD3 protein on T-cells and DLL3, a protein overexpressed by certain cancer cells, while barely being present in healthy cells 3. How effective is Imdelltra (tarlatamab) for lung cancer? Based on the available clinical trial results, this is what we know about its efficacy: 40% of patients treated with Imdelltra had their tumor shrink or disappear; The median duration of response was 9.7 months; For 68% of patients, their response to the therapy lasted at least 6 months 4. Is Imdelltra available in Poland? As of March 2025, Imdelltra is not yet approved in the EU or available in Poland. It is currently only approved in the USA and, since January 2025, in the United Kingdom 5. However, if your oncologist considers it suitable for your condition, you can get the medicine right away in Poland. We can help you get started below, if you already have a prescription.   #2: Hetronifly (seribantumab) – a new medicine for small cell lung cancer Approved in the EU in February 2025, Hetronifly (seribantumab) is indicated as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC), alongside carboplatin and etoposide. Hetronifly is currently the only anti-PD-1 monoclonal antibody approved in the EU for the treatment of small cell lung cancer 6. How effective is Hetronifly? Based on the results of the phase 3 ASTRUM-005 clinical trial, this is what we know about seribantumab’s success rate in SCLC: The median overall survival was 15.4 months for patients taking Hetronifly, compared to 10.9 months in the placebo group; The median progression-free survival was 5.7 months for the Hetronifly group, compared to 4.3 months for the placebo group 7. These results point to the potential importance of seribantumab as a first-line therapy to improve overall survival in patients with small cell lung cancer. Is Hetronifly available in Poland? Despite its recent EU approval, Hetronifly is not yet available in Poland. On average, it takes 888 days from EMA approval until an oncological medicine becomes available to Polish patients. While this timeline can vary per medicine, it wouldn’t be surprising if Hetronifly only gets to Poland around 2027. This being said, if you have a doctor’s prescription, you may be able to legally access the treatment right away. Get in touch with our expert Medicine Access team for support. What are the newest targeted therapies for lung cancer in the world [2025]? In addition to immunotherapy, new targeted therapies have also been developed in recent years to attack specific genetic mutations responsible for lung cancer. These treatments help provide more personalized and often more effective options for patients. Here are some of the latest targeted medicines for lung cancer. #1: Lazcluze/Leclaza (lazertinib) — the new pill for EGFR-positive NSCLC Lazertinib is a third-generation oral targeted therapy for non-small cell lung cancer (NSCLC) with EGFR mutations. It was first approved in South Korea in 2021, and since then has also gained FDA and EMA approval. How effective is lazertinib for lung cancer? Clinical studies show that Lazertinib (Leclaza/Lazcluze), alone and in combination with Rybrevant (amivantamab), offers promising results for EGFR-mutated non-small cell lung cancer (NSCLC): As a first-line treatment (LASER301 study): Median progression-free survival (PFS): 20.6 months with Lazertinib vs. 9.7 months with gefitinib. Median duration of response: 19.4 months with Lazertinib vs. 8.3 months with gefitinib. 18-month survival rate: 80% with Lazertinib vs. 72% with gefitinib 8. In combination with Rybrevant (MARIPOSA trial): Progression-free survival: 23.7 months with Lazertinib + Rybrevant vs. 16.6 months with osimertinib. Median duration of response: 25.8 months with Lazertinib + Rybrevant vs. 16.8 months with osimertinib. Overall survival (OS): Expected to extend survival by more than one year beyond Tagrisso (osimertinib), with the potential to surpass four years, approaching curative outcomes for some patients 9. As a second-line treatment (for EGFR T970M mutation): Disease control rate: 72.8% of patients had stable disease or tumor shrinkage. Progression-free survival rates: 81.7% at 6 months and 65.1% at 12 months. These results position Lazertinib — especially when combined with Rybrevant — as a strong alternative to Tagrisso. And, as a potential new standard for EGFR-mutated NSCLC treatment. Is Lazertinib available in Poland? EMA approval for Lazertinib is expected any day now. The CHMP recommended granting it marketing authorization in November 2024, and making the approval official takes about two months 10. However, in Poland, the average wait time for public access after EMA approval is over 800 days. Fortunately, with a valid prescription, you can access the medicine immediately. Get started by requesting it below.

What’s Better: Wegovy or Mysimba? A Comparison of Two Weight Loss Medicines

What’s Better: Wegovy or Mysimba? A Comparison of Two Weight Loss Medicines As obesity rates continue to climb globally, more people are seeking effective medicines to aid with weight loss. Although Ozempic has recently become a household name for weight loss, it is important to note that it is not officially approved for this purpose. Fortunately, there are several viable alternatives to Ozempic available in Germany. Among them are Wegovy and Mysimba, each offering a different approach to achieving weight loss. If you’re curious about how these two medicines compare to one another, you’ve come to the right place. In this article, we will explore the mechanisms of action, effectiveness, potential side effects, and costs associated with Wegovy and Mysimba. This will help you and your doctor make an informed decision about which option may be better for you. What are Wegovy and Mysimba? Both Wegovy and Mysimba are prescription medicines used for weight management, but they work in very different ways. Wegovy (semaglutide) is a GLP-1 receptor agonist. It was originally developed for diabetes treatment but is now approved for weight loss. It works by mimicking a natural hormone that helps regulate appetite and food intake. Overall, Wegovy focuses on appetite suppression and metabolic regulation. Mysimba (naltrexone/bupropion) is a combination medicine that targets brain areas that control hunger signals and feelings of fullness. It helps reduce emotional eating and control food cravings. Both medicines are intended for people with obesity (BMI ≥ 30) or those who are overweight (BMI ≥ 27) with weight-related health conditions like type 2 diabetes or high blood pressure 1,2. Mysimba vs Wegovy: How are they administered? One notable difference between Wegovy and Mysimba is the way they are administered. Similar to Ozempic, Wegovy is a once-weekly injection. Mysimba, on the other hand, is a tablet, taken orally. This makes it a good option for patients who dislike needles. Is Wegovy or Mysimba more effective for weight loss? According to the available clinical trial results, this is how effective Wegovy and Mysimba are: Wegovy clinical trial results In the STEP-1 trial, patients took either Wegovy or placebo along with lifestyle interventions. The reported results were: Patients taking Wegovy lost on average 14.9% of their body weight over 68 weeks, compared to 2.4% in the placebo group; 50.5% of Wegovy patients lost >15% of their body weight, compared to 5% of the placebo group 3. Mysimba clinical trial results Across four main studies, Mysimba was compared to placebo – both alongside lifestyle interventions. The key outcomes were: Patients taking Mysimba lost an average of 8.1% of their body weight. In the placebo group, the result was 4.9%; 30% of Mysimba patients lost >10% of their body weight 4. Based on these results, Wegovy appears to be a more effective option for significant weight loss. Mysimba can be a good alternative in case Wegovy is not suitable for you, or if your goal is to control food cravings and emotional eating. Wegovy vs Mysimba: Side effects Like all medicines, Wegovy and Mysimba have potential side effects. Here’s a brief overview of how they compare. Wegovy side effects Most common: Nausea, vomiting, diarrhea, constipation, stomach pain, fatigue. Serious: Increased risk of thyroid tumors (based on animal studies), pancreatitis, acute gallbladder disease, acute kidney injury, hypoglycemia, serious hypersensitivity reactions, diabetic retinopathy complacations in patients with type 2 diabetes, heart rate increase, and suicidal behavior. Not recommended for: People with a personal or family history of medullary thyroid cancer, as well as anyone who has had an allergic reaction to semaglutide or a similar medicine in the past 1. Mysimba side effects Most common: Nausea, constipation, vomiting, dizziness, dry mouth. Serious: Increased risk of seizures (especially in people with a history of epilepsy), risk of depression and suicidal thoughts, allergic reactions, severe cutaneous adverse reactions, raised blood pressure, cardiovascular disease, Brugada syndrome, liver and renal impairment, serotonin syndrome. Not recommended for: Individuals with significantly compromised kidney or liver functions, those suffering from uncontrolled hypertension, those with a history of seizures, plus patients dealing with certain psychological disorders, brain tumors, substance withdrawal, or currently on opioid medications 2. It’s clear that both medicines have side effects. While some can be quite serious, they are rare for both medicines. Your doctor will best be able to determine if Wegovy or Mysimba are an option for you, based on your medical history and current condition. Wegovy vs Mysimba: How much do they cost? The price of weight loss medicines can be an important factor in choosing between Wegovy and Mysimba (if they are recommended by your doctor). Here is a quick comparison of the (approximate) costs of either medicine per month, and its availability in Germany. Which is better for you – Wegovy or Mysimba? The only person who can answer this question is your doctor. However, to help you have a conversation with them, here’s a summary of who each medicine may be more suitable for. Wegovy may be more suitable if: You need significant weight loss (10-15% of body weight). You don’t mind taking weekly injections. Your obesity is related to a metabolic disorder. You have no history of medullary thyroid cancer. Mysimba may be more suitable if: You struggle with food cravings and emotional eating. You prefer oral tablets instead of injections. You have no history of seizures, high blood pressure, or mood disorders. You want a more affordable option. How to get the weight loss medicine you need If your doctor prescribes Wegovy for your weight loss, you can find it in Germany. Mysimba is currently not available in Germany. References: Highlights of prescribing information. Accessdata.fda.gov, Accessed 10 March 2025.  Summary of product characteristics. EMA, Accessed 10 March 2025.  Once-Weekly Semaglutide in Adults with Overweight or Obesity. The New England Journal of Medicine, 10 February 2021.  Mysimba | European Medicines Agency (EMA). EMA, Accessed 10 March 2025.

Does Medicare Cover Tymlos for Osteoporosis (and what if it doesn’t)?

Anktiva for off-label use: All you need to know. Anktiva is one of the latest cancer treatments to get FDA approval. At the moment, it is approved in the USA for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). In Saudi Arabia, Anktiva is also approved for use in non-small cell lung cancer (NSCLC).  While Anktiva is currently approved for these specific indications, it is also being studied in other cancers – suggesting its potential may extend beyond its current use. In some cases, patients and their doctors may consider off-label prescribing based on emerging evidence, rather than waiting (often years) for approval from agencies like the U.S. Food and Drug Administration. In this article, we explain what off-label use means, which indications may be considered based on current evidence, and how patients may be able to access Anktiva if prescribed off-label. What is off label prescribing? Off-label prescribing means using an approved medicine in a way that isn’t listed in its official approval – such as for a different condition, dose, or group of patients. Once a medicine like Anktiva is approved, doctors can legally prescribe it off-label if they believe it’s appropriate. This is common in cancer care, where patients may need to explore all possible options within a limited timeframe. For example, although Anktiva is approved for BCG-unresponsive NMIBC, a doctor might consider using it for other stages of bladder cancer or even different cancer types, based on early evidence and the patient’s specific situation. Is off-label prescribing legal? Yes, off-label prescribing is legal and common in medicine, including oncology. While medicines are approved for specific uses based on data submitted to agencies like the U.S. FDA, doctors are not limited to those uses. In some cases, strong clinical trial data for a new indication may already exist, but the manufacturer has not yet submitted it for approval – or it is still under review. For example, although Anktiva is approved for BCG-unresponsive NMIBC, a doctor might consider using it for other stages of bladder cancer or even different cancer types, based on early evidence and the patient’s specific situation.  As long as the decision is supported by sound medical judgment and scientific data, doctors can prescribe off-label. This flexibility allows them to tailor treatment to each patient – especially when standard options are limited or no longer effective. When might your doctor consider Anktiva off-label use? A doctor may consider using Anktiva off-label when there is a good scientific reason to believe it could help beyond its approved use – especially in conditions with few treatment options, where trying something new may be justified. This could be based on early clinical trial results, case reports, or how the medicine works. For example, in non-small cell lung cancer (NSCLC), a doctor in the United States could technically prescribe Anktiva off-label even though it is not yet approved for this use there (while it may be used in countries like Saudi Arabia). In making that decision, the doctor might review available clinical trial data and, in some cases, consult with colleagues who already have experience using the treatment in that setting. Can Anktiva be used off label in your country? Most likely, yes. Off-label prescribing is widely accepted and practiced worldwide, with an EU survey indicating that between 3-95% of adult prescriptions in the region may be for off-label use. With this in mind, if your doctor considers that Anktiva may be a suitable treatment for your condition and situation, in most cases they can legally prescribe it to you – regardless of whether it is locally approved. Some countries may have stricter regulations for off-label use, requiring additional approvals or justifications. You can explore these specific requirements together with your treating doctor, if you want to consider Anktiva off-label use.  For which conditions could Anktiva be prescribed off-label? While Anktiva is approved for BCG-unresponsive NMIBC (and for NSCLC in Saudi Arabia), it is also being studied in other cancers. Doctors may technically prescribe it off-label for a number of indications, but in practice they are most likely to do so for indications where there is already solid clinical trial data or a clear scientific rationale. Below are the Anktiva indications where research is most advanced, and where off-label use may be more realistically considered. Non-Small Cell Lung Cancer (NSCLC) Anktiva is already approved in Saudi Arabia for use in metastatic NSCLC. This increases the likelihood of a doctor elsewhere considering off-label use for this indication. The approval was based on the Phase III study QUILT-3.055 in people with advanced lung cancer (NSCLC) who had already received treatment. It compared Anktiva® plus an immunotherapy drug to standard chemotherapy. Key findings included: In studies including 151 patients, Anktiva helped restore immune function, which was linked to longer survival; Patients receiving Anktiva plus immunotherapy showed a clear increase in immune cell levels compared to immunotherapy alone; 77% of patients in later-line treatment maintained or regained healthy immune cell levels; Patients whose immune system improved lived longer: about 16.2 months vs 11.8 months; Those with stronger immune recovery lived even longer: about 21.1 months. Pancreatic cancer Anktiva is not yet approved anywhere for use in pancreatic cancer. However, the FDA granted it an RMAT (Regenerative Medicine Advanced Therapy) designation, recognizing it as a promising therapy in development, for which clinical data show restoring immune cells and longer survival across multiple cancers, including pancreatic cancer. As such, your doctor may consider off-label use for this indication. One of the key studies currently focused on pancreatic cancer is the QUILT-88 trial, which combines Anktiva with chemotherapy, radiation, and NK cell therapy.  Results presented at the American Society of Clinical Oncology 2025 meeting showed encouraging outcomes for this difficult-to-treat population: Patients treated in third-line or later settings lived about 5.7–6.2 months on average, which is relatively strong given the lack of standard options; Some patients experienced much longer responses, with a few remaining on treatment for up to ~2 years; Better outcomes were linked to higher immune cell levels (lymphocytes). Glioblastoma Glioblastoma is another area where Anktiva is being studied, particularly in patients

Getting Prescription Medicines From Abroad: All You’ll Ever Need to Know

Getting Prescription Medicines From Abroad: All You’ll Ever Need to Know If you’re ever in a situation where you can’t get the treatment you need in your country, this article contains everything you need to know. You’ll learn how to get prescription drugs from abroad, what is and isn’t allowed, what to avoid, and key considerations for ensuring safety.  Let’s get started.  Why get prescription medication from abroad? There can be many reasons to consider sourcing medication from another country, including delays in local availability, or cost savings. Exploring these options requires careful consideration, and you should always do it together with your treating doctor.  Below are some of the main reasons to seek access to medicine in another country.  #1: The drug you need isn’t approved in your country (yet) This is the most common scenario. Many medicines are approved first in countries like the USA, while patients elsewhere may wait months – or years – for local approval. When your condition can’t wait, accessing treatment from a country where it’s already available becomes a real option. #2: The drug you need is approved in your country, but not available (yet) Approval doesn’t mean immediate access. Even after approval, it can take months or years before a medicine is launched locally. This delay can leave patients without timely treatment. In these cases, sourcing the medicine from abroad can help avoid interruptions or delays in care. #3: The drug you need is considerably cheaper abroad Prices for the same medicine can vary widely between countries. For patients paying out of pocket – especially for long-term treatment – buying abroad can sometimes make treatment financially possible. How to get a prescription medicine from another country In many cases, getting medicine from abroad is legal – but the rules depend on your situation. #1: How to get a medicine if it isn’t approved in your country yet When a necessary prescription drug isn’t yet approved in your country, you have several options. Join a clinical trial Novel medicines are often still undergoing clinical research after approval. If there is a suitable clinical trial, for which you qualify, joining it may be a fast way to get treatment with the newly approved medicine. Note, however, that in clinical trials you can also be assigned to the control group, so there is no guarantee you will in fact get the treatment.  If you and your medical team are open to this idea, you can explore global clinical trials and enrol.  Contact the medicine manufacturer Often, Pharma companies establish Expanded Access Programs when launching a medicine. These programs are intended to help patients access the treatment in locations where it is not marketed yet. If there is such a program for the medicine you need, your doctor will need to apply for it on your behalf.  Personal importation If there is no Expanded Access Program for the medicine you need, and a clinical trial is not an option, there’s something else you can do. You have the right to import a prescription medicine for personal use from another country. This is possible due to the so-called Named Patient Import regulation, which is in place worldwide.  Personal importation is allowed when: The medicine is for a life-threatening or debilitating disease; There is no approved alternative in the patient’s country; The medicine has been prescribed by the treating doctor; The medicine is strictly for personal use. You can exercise your right to Named Patient Import in any country – just keep in mind that the documents required may vary per country. To help you understand the process for personal importation in your country, we’ve put together a Global Medicine Import Guide.  #2: How to get a medicine if it isn’t available in your country yet   This may sound contradictory, but medicine approval and medicine availability are not the same thing, and there can be years between the two events. In the EU, for example, after a medicine gets EMA approval, it can take between 3 months (in Germany) and 3 years (in Portugal) for the medicine to reach patients. So, sometimes, you may find yourself in the absurd situation of not being able to find a medicine that is approved in your country. If you’re in this situation, you can use the Named Patient Import outlined above to access your treatment.  #3: How to get a medicine if it’s cheaper abroad This is more complex and depends heavily on your location. Europe In Europe, if a medicine is approved and available locally, but cheaper in another country, you could ask your doctor for a cross-border prescription. With that, you can fill your prescription in another EU country. Note that the local pharmacist applies local laws and regulations, so always check in advance with the pharmacy abroad before you make the trip or place the order. USA In the United States, importing for cost reasons is common in practice due to high prices, but under FDA rules it falls into a legal grey area. Personal importation rules are designed for unmet medical needs, rather than price. Therefore, if you order an FDA-approved prescription medicine from abroad and have it shipped to you in the USA, it will not be allowed in. This being said, if you personally purchase a medicine from a pharmacy abroad and bring it back with you to the USA, there is nothing prohibiting you from doing that, as long as you have all documentation with you (e.g. prescription, invoice), and you stay within the limit of a 3-month supply.  Rest of the world Most countries technically allow personal import with a prescription, but when the medicine is already approved locally, importing it for a lower price is often unofficially tolerated rather than clearly regulated. In other words, there’s a risk if you get a medicine shipped to you. However, you can purchase it abroad and bring it back with you, as long as you have the appropriate documentation with you, and you stay within a short-term supply. What isn’t allowed While