May 19, 2024: Promising lung and prostate cancer treatments; cancer drug dosage concerns; gout risk and prediabetes; medication tips for NSAIDs; blood pressure drugs; meds & dental health
FDA approves SCLC drug; Promising radiation-oncology therapy for prostate cancer
The U.S. Food and Drug Administration (FDA) approved, on an "accelerated" basis, Amgen's Imdelltra (tarlatamab), a targeted immunotherapy for advanced, hard-to-treat small cell lung cancer (ES-SCLC). Patients must either be receiving platinum-based chemotherapy (such as cisplatin) or have already been treated with it. Amgen says that a mid-stage trial study published last year in the New England Journal of Medicine showed that tumors shrank in 40% of patients receiving 10 mg of tarlatamab by intravenous infusion every two weeks. About 35,000 patients in the U.S. have SCLC; non-small cell lung cancer (NSCLC) is the more common form of lung cancer. Amgen is also testing tarlatamab for treating patients with earlier-stage small cell lung cancer. The "accelerated" approval means that continued approval will require verification of clinical benefits in a confirmatory trial.
https://www.healthday.com/health-news/cancer/fda-approves-new-drug-for-deadly-lung-cancer
FDA press release
The FDA approved the expanded use for Bristol Myers Squibb's "CAR-T" cancer cell therapy Breyanzi (lisocabtagene maraleucel) for the treatment of adults with a type of blood cancer called follicular lymphoma, that has returned or has not responded to prior treatments. This is the fourth approval for Breyanzi.
https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-expanded-use-bristols-cancer-cell-therapy-2024-05-15/
Radiation Oncology: Promising Treatments
We asked Dr. Stacy Wentworth, radiation oncologist and author of "Cancer Culture" on Substack, to comment on some of the most promising treatments in the field of radiation oncology. She said that a new compound that targets metastatic prostate cancer has "shown wonderful progress and institutions all over the US are scrambling to set up treatment protocols” and notes that “delivering the radiation directly to the tumor cells and minimizing exposure to normal tissue is the future of radiation oncology. "
The treatment, Novartis' lutetium-177-PSMA-617 or LuPSMA, (brand name Pluvicto) was approved in 2022 to treat prostate cancer that has become resistant to other forms of ADT (androgen deprivation therapy) and chemotherapy. Because Pluvicto is a radiopharmaceutical, specific safety measures are taken to minimize radiation exposure. The drug is also being studied as a therapy for earlier stages of prostate cancer.
In the past 5 years, biotech start-ups researching treatments like Pluvicto have been "springing up like mushrooms." This is because, "like external radiation therapy, these drugs use radiation to kill tumors, but they do it internally with the help of cancer-seeking guides."
https://cen.acs.org/pharmaceuticals/oncology/Targeted-radioactive-drugs-raise-hopes-cancer/100/i13
University of Chicago Cancer Center was the first treatment center in Illinois to administer Pluvicto. The therapy is used with the companion diagnostic gallium-68 gozetotide (Locametz), which is more commonly known as a PSMA PET scan. A PSMA PET scan visualizes the locations of metastatic prostate cancer and can identify patient candidates for Pluvicto theranostic therapy. During treatment, the PSMA grabs on to the lutetium-177 PSMA; the radiation it carries is absorbed into the cancer cell, damaging its DNA and ultimately causing cell death. Includes a one and a half minute video that explains the technology of theranostics.
https://www.uchicagomedicine.org/cancer/types-treatments/prostate-cancer/treatment/lutetium-177-psma-therapy-for-prostate-cancer
Eladio Ruiz of Savannah, Georgia was interviewed before undergoing treatment for prostate cancer using Pluvicto. He says it’s been a long road to even get prepared to try the medication which is reserved for patients who have already tried other therapies.
https://www.wtoc.com/2024/04/26/first-person-coastal-empire-receive-new-cancer-treatment/
Cautionary Tale for Cancer Patients and Providers
Cancer treatments often have risky side effects, so when a patient decides against taking a particular treatment, the non-consent should be noted and adhered to by a patient's healthcare providers. Sometimes, however, lack of consent can slip through the cracks. In an unfortunate case, Sheila, diagnosed with Stage 4 ovarian cancer, told her doctors that she did not want to take Avastin (bevacizumab) because of the risk of debilitating side effects, but she mistakenly received the infusion anyway, and soon after experienced intestinal perforations and other complications. Australian-based medical doctor Paul Singh shares his friend Sheila's story as a lesson to help other patients avoid similar mismanaged care.
https://medshadow.org/the-catastrophic-consequences-of-careless-consent-with-chemotherapy/
Accelerated Approval of Cancer Drugs can Lead to Toxic Dosages
KFF Health News reports that the FDA has begun requiring drug companies to pinpoint the right dosage before they reach patients. Amgen's Lumakras (sotorasib) for lung cancer (NSCLC) has caused debilitating side effects in patients. The fact that the approved dose was too high for most patients was only discovered after the drug, which was approved on an accelerated basis, went on the market in February 2023. “There’s a gap in FDA’s authority that results in patients getting excess doses of a drug at excess costs,” said Mark Ratain, a University of Chicago oncologist who has pushed for more accurate cancer drug dosing.
https://kffhealthnews.org/news/article/amgen-cancer-drug-sotorasib-lumakras-high-dosage-fda-dosing-trials/
New Self-Administered Tests for HPV
The FDA approved BD's Onclarity test and Roche's self-collection cervical cancer screening tests. These tests don't require a pelvic exam or PAP smear, but still must be conducted in a health care setting or doctor's office. As with an in-office urine test, the medical provider will provide the self-collection swab to take into a bathroom where the patient collects the sample and then the provider processes the test.
https://www.usatoday.com/story/news/health/2024/05/15/fda-approves-self-tests-for-cervical-cancer/73498865007/
Research Study: Metformin and Gout Flares
Individuals who are prediabetic are more likely than others to experience gout flares, a common form of inflammatory arthritis that often affects the big toe joint. It is characterized by excessive amounts of uric acid in the blood, which can cause sudden gout flares (attacks) due to needle-like deposits of uric-acid crystals in the joints, causing redness, swelling and pain.
Researchers in the Division of Rheumatology at Brigham and Women's Hospital compared the incidence rates of gout in adults with prediabetes starting diabetes drug metformin with those not using antidiabetic treatments. Electronic health records for 25,064 patients with pre-diabetes were analyzed from an academic health system (2007–2022). Metformin use was associated with a reduced risk of gout among adults with prediabetes, suggesting that metformin may be important in lowering gout risk in individuals with prediabetes and may include anti-inflammatory and urate lowering effects. The study was published in BMJ's Annals of the Rheumatic Diseases.
https://ard.bmj.com/content/early/2024/05/15/ard-2024-225652
Regulatory News
Lykos Therapeutics’ Midomafetamine (MDMA)-assisted therapy will be considered for approval by the U.S. Food and Drug Administration (FDA) for the treatment of post-traumatic stress disorder (PTSD). The agency’s advisory committee is set to deliberate on its recommendation June 4. MDMA, also known as "ecstasy," currently has a Schedule 1 classification with the Drug Enforcement Administration, so is now designated as a substance with no medicinal value and a high potential for abuse. Lykos received a New Drug Application approval from the FDA in February to study MDA in combination with psychotherapy and other psychiatric interventions.
https://healthexec.com/topics/healthcare-management/healthcare-policy/fda-set-evaluate-use-ecstasy-treating-ptsd
At the 2024 Food Drug Law Institute annual conference, Patrizia Cavazzoni, director of the Center for Drug Evaluation and Research (CDER), said that the FDA does not intend to further delay enforcement of requirements for manufacturers’ track and trace verification systems under the Drug Supply Chain Security Act (DSCSA) and that she expects those systems to be up and running by this November. Cavazzoni also said there was a “significant uptick” in New Drug Applications containing Artificial Intelligence (AI) elements. In 2015, the agency received just one such submission, and in 2022, CDER had 175 submissions containing AI elements.
https://www.raps.org/News-and-Articles/News-Articles/2024/5/Cavazzoni-No-more-%E2%80%98kicking-the-can-down-the-road-f
Medication Tips: NSAIDs, Blood Pressure Meds, Dental Health
People's Pharmacy's columnist and radio show host Joe Graedon answered the 2-part question, "Can NSAIDs damage the kidneys? And if you try to protect your stomach from NSAID damage with a PPI, will you increase kidney damage?" He suggests that people should be wary of chronic use of NSAIDs like ibuprofen and naproxen, because in addition to damaging the digestive tract, they can be hard on the kidneys. Chronic use can also elevate your blood pressure and lead to cardiovascular complications. Check out his complete answer here:
https://www.peoplespharmacy.com/articles/can-you-wreck-your-kidneys-with-nsaid-pain-relievers
In this article, MedShadow provides an in-depth explanation of hypertension, or high blood pressure. Check it out, along with its special section on potential side effects of blood pressure lowering meds according to drug type.
https://medshadow.org/everything-you-need-to-know-about-blood-pressure-2/#Side_Effects_of_Blood_Pressure_Lowering_Drugs
To continue your blood pressure meds research, get this free blood pressure guide download to your desktop: AskaPatient's booklet (PDF format) contains a comprehensive directory of 138 blood pressure medications with links to current drug labels.
Did you know that many prescription drugs can lead to problems with your teeth and gums? For example, seizure drug phenytoin or calcium channel blockers like amlodipine may cause the gingival (gum) tissues to enlarge and even cover the tooth. Prolonged use of antibiotics can lead to staining of the teeth or oral thrush. Osteoporosis drugs like bisphosphonates may lead to problems with teeth stability, including osteonecrosis of the jaw or jaw pain. It's very important for your dentist to know if you are taking a drug from this class of medicines. Other drugs can cause oral health problems such as dry mouth. Check out this article on MedShadow for many more examples and the complete report.
https://medshadow.org/how-medications-affect-your-dental-health-2/
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