Wednesday, May 8, 2024
HomeCancerNew Drug For Prostate Cancer Approved By Fda

New Drug For Prostate Cancer Approved By Fda

T Cell In Colorectal Cancer Therapy

New FDA Approved: Pluvicto (Lutetium-177) for Advanced Prostate Cancer | Mark Scholz, MD | PCRI

The existing evidence showed that T cells have a strong anti-tumor function in vitro and in vivo. Using T cells expanded in vitro for tumor cell immunotherapy can effectively control or relieve the tumor patients with very few cells or severely defective T cell function. However, there are still many unknowns about the application of T cell therapy in the treatment of colorectal cancer. The above-mentioned study by Wu et al. fills the gap in the study of T17 cells in colorectal tumors, and also provides the possibility for tumor treatment and prognosis prediction by targeting T17 cells, which guides new strategies for future clinical transformation. If you are exploring the application of T cell therapy in colorectal cancer, Creative Biolabs will provide you with a full range of guidance and assistance.

Two Agents Approved For Psma

On May 26, FDA approved piflufolastat F 18 for use in a type of imaging procedure called PSMA PET in people with prostate cancer. The approval covers the use of piflufolastat F 18 in patients suspected of having metastatic prostate cancer or recurrent prostate cancer . Last year, the agency approved another imaging agent for PSMA PET, Ga 68 PSMA-11, for the same uses, but its use is largely limited to the two institutions where it is made.

In a statement, Lantheus, which manufactures piflufolastat F 18, said the imaging agent will be immediately available in parts of the mid-Atlantic and southern regions with broad availability across the U.S. anticipated by year end.

PSMA is often overproduced by prostate cancer cells but is generally not produced by most normal cells, making it an excellent target for both PET imaging and targeted systemic radiation therapy like 177Lu-PSMA-617, Dr. Morris said.

Physical Emotional And Social Effects Of Cancer

Cancer and its treatment cause physical symptoms and side effects, as well as emotional, social, and financial effects. Managing all of these effects is called palliative care or supportive care. It is an important part of your care that is included along with treatments intended to slow, stop, or eliminate the cancer.

Palliative care focuses on improving how you feel during treatment by managing symptoms and supporting patients and their families with other, non-medical needs. Any person, regardless of age or type and stage of cancer, may receive this type of care. And it often works best when it is started right after a cancer diagnosis. People who receive palliative care along with treatment for the cancer often have less severe symptoms, better quality of life, and report that they are more satisfied with treatment.

Palliative treatments vary widely and often include medication, nutritional changes, relaxation techniques, emotional and spiritual support, and other therapies. You may also receive palliative treatments similar to those meant to get rid of the cancer, such as chemotherapy, surgery, or radiation therapy.

Learn more about the importance of tracking side effects in another part of this guide. Learn more about palliative care in a separate section of this website.

Also Check: Prostate Cancer Side Effects Of Radiotherapy

Advantages Of T Cells In Immunotherapy

T cells are defined by expression of and heterodimer of T cell receptor chains that directs intracellular signaling without the recognization of MHC molecule. Unlike Ag-specific T cells, T cells can kill tumor cells in a manner that does not require the recognition of tumor-specific Ags. They have shown significant advantages in cancer immunotherapy, including but not limited to the followings:

  • T cells play naturally cytotoxic roles via a number of different mechanisms.
  • Through antigen presentation and cytokine/chemokine release, T cells orchestrate downstream immune responses.
  • T cells are completely safe for healthy cells, even when introduced at very high numbers.
  • T cells directly lyse cancer cells through the perforin-granzyme pathway.
  • T cells are ideal candidates for allogeneic off the shelf therapies because they are not MHC-restricted and dont cause graft versus host disease .
  • T cells can be produced in large scale through GMP methods.
  • Fda Approves Leuprolide Acetate Injection For Advanced Prostate Cancer

    U.S. FDA Approves New Indication For The Use of XTANDI® (enzalutamide ...

    An abbreviated new drug application was approved by the FDA for leuprolide acetate injection as treatment of patients with advanced prostate cancer.

    The FDA has granted approval to an abbreviated new drug application for leuprolide acetate injection for patients with advanced prostate cancer, according to a press release from Amneal Pharmaceuticals.1

    This leuprolide acetate injection is indicated for palliative treatment in patients with advanced prostate cancer. The abbreviated application is used for the review and approval of generic drugs.2

    We are making tremendous progress expanding our injectables business. This latest new product is another key therapeutic for the institutional market and another complex, high-value launch by the team, Harsher Singh, senior vice president for Amneal Biosciences, said in the press release.

    Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin releasing hormone which acts as an inhibitor of gonadotrop in secretion. Then injection is a sterile, aqueous, clear, solution intended for subcutaneous injection.

    The injection is available in a 2.8 mL multiple-dose vial containing leuprolide acetate, 5 mg/mL, sodium chloride, USP for tonicity adjustment, benzyl alcohol, NF as a preservative , and water for injection, USP.

    REFERENCES
  • Leuprolide acetate injection. Amneal Pharmaceuticals, Inc. Accessed November 3, 2022. https://bit.ly/3sQ1LDU
  • Also Check: Prostate Cancer Removal Of Testicles

    Fda Approves New Prostate Cancer Treatment

    A targeted radioligand therapy, Pluvicto , has been approved for use in adults with previously treated metastatic castration-resistant prostate cancer . All eligible patients must have been previously treated with taxane-based chemotherapy and androgen receptor pathway inhibition, and test positive for a prostate-specific membrane antigen .

    The efficacy of the treatment was evaluated in VISION, a randomized, open-label trial that compared best standard of care alone vs with lutetium Lu 177 vipivotide tetraxetan in 831 men with PSMA-positive mCRPC that was progressing. Patients were randomly assigned in a 2:1 ratio to receive either the best standard of care plus lutetium Lu 177 vipivotide tetraxetan, 7.4 GBq every 6 weeks until as many as 6 doses were given, or to the best standard of care alone.

    VISION showed a statistically significant improvement in overall survival with lutetium Lu 177 vipivotide tetraxetan. For OS, the hazard ratio for the treatment plus best standard of care compared with best standard of care alone was 0.62 . In the treatment plus best standard of care arm, median OS was 15.3 months vs 11.3 months in the best standard of care alone arm.

    The recommended dose of lutetium Lu 177 vipivotide tetraxetan is 7.4 GBq given intravenously every 6 weeks until 6 doses have been given, the cancer progresses, or unacceptable toxicity results.

    Reference:

    How Utsw Is Revolutionizing Prostate Cancer Treatment

    UT Southwestern is on the leading edge of a surgical technique that treats prostate cancer without some of the impactful side effects. It features an MRI-guided device that uses ultrasound heat to destroy the tumors, and no academic medical center has performed more of them than UTSW.

    The American Cancer Society found that more than 250,000 new prostate cancer were detected in 2022, and 34,500 people died from prostate cancer last year. One in eight men will eventually be diagnosed with prostate cancer which usually develops in older men. Prostate cancer is the second leading cause of cancer death in American men, behind lung cancer. One in 41 men will die from it. Even though the deaths and impact of prostate cancer are nearly as significant as breast cancer, the amount of research and funding for its treatment is far below that of breast cancer.

    Conventional treatment involves a combination of surgery and radiation to remove the tumor. But these treatments leave a lot to be desired in terms of treating the disease and preserving the quality of life, says Dr. Daniel Costa, an associate professor of radiology at UT Southwestern Medical Center who was involved in the trials of this technology and performs the surgery. He says that when men are diagnosed with prostate cancer, patients can sometimes push back because of the side effects, namely sexual impotence and incontinence.

    Also Check: Vitamins For Prostate Health Mayo Clinic

    Philip Low’s Other Impact On Drug Discovery And Development

    On Nov. 29, the FDA approved another of Low’s innovations, a drug designed to help surgeons find ovarian cancer tumors and cells by turning them fluorescent green. On Target Laboratories, which licensed the imaging agent through OTC, markets the drug with the brand name Cytalux.

    Low also co-directed international research on a Phase 2 clinical trial that showed a repurposed cancer drug was 100% effective in defeating malaria within three days.

    About Purdue Research Foundation Office of Technology Commercialization

    Writer: Steve Martin,

    Making Treatment Choices: Olaparib Or Rucaparib

    FDA approves new diagnostic that can help beat Prostate Cancer

    Often, when multiple drugs are approved for the sameor in this case, a very similaruse, the side effects associated with each drug can help doctors decide which therapy is best for each patient.

    Overall, Dr. Sartor explained, there arent notable differences in the types or severity of the side effects caused by olaparib and rucaparib.

    And although most patients seem to handle the side effects caused by both drugs relatively well, he continued, they can cause substantial problems, including anemia, severe drops in white blood cell count, nausea, and vomiting.

    Dr. Karzai also pointed to the risk of myelodysplastic syndrome, a disorder that affects the formation of blood cells in the bone marrow and that has been seen in a very small percentage of patients treated with PARP inhibitors.

    These drugs definitely require close monitoring , Dr. Sartor said.

    One potential advantage of rucaparib over olaparib could be the eventual availability of a blood test, called a liquid biopsy, that can identify men with BRCA1 or BRCA2 alterations who are candidates for the drug. This liquid biopsy, called FoundationOne Liquid CDx, is currently being evaluated by FDA and a decision on its approval is expected soon, according to a spokesperson for Foundation Medicine, which manufactures the test.

    In addition to tissue quantity, there are also issues with the type of tissue that comes from the biopsy and its quality. There a lot of variables that can make it difficult, she added.

    Also Check: What’s The Best Treatment For Enlarged Prostate

    If Treatment Does Not Work

    Recovery from cancer is not always possible. If the cancer cannot be cured or controlled, the disease may be called advanced or terminal.

    This diagnosis is stressful, and for some people, advanced cancer may be difficult to discuss. However, it is important to have open and honest conversations with your health care team to express your feelings, preferences, and concerns. The health care team has special skills, experience, and knowledge to support patients and their families and is there to help. Making sure a person is physically comfortable, free from pain, and emotionally supported is extremely important.

    People who have advanced cancer and who are expected to live less than 6 months may want to consider hospice care. Hospice care is designed to provide the best possible quality of life for people who are near the end of life. You and your family are encouraged to talk with the health care team about hospice care options, which include hospice care at home, a special hospice center, or other health care locations. Nursing care and special equipment, including a hospital bed, can make staying at home a workable option for many families. Learn more about advanced cancer care planning.

    After the death of a loved one, many people need support to help them cope with the loss. Learn more about grief and loss.

    Advantages Of T Cell Therapy

    T cell-based immunotherapy is becoming a major trend in cancer treatment. In particular, CAR-T cells, which are genetically modified T cells, have shown a significant remission rate in patients who have not responded to many other drugs. Nevertheless, CAR-T still has its limitations, such as strong and sometimes fatal side effects, and its ability to target solid tumors is also limited. Among the various solutions, there is a type of research that focuses on a specific subtype of T cells, called T cells. These cells account for only 5% of all T cells in the human body, but they play an important role in fighting cancer.

    Different from T cells that are usually used to prepare CAR-T therapy, T cells play a role in the innate immune response, which constitutes the first and faster line of defense of the immune system.

    Another major advantage of T cells is that their ability to recognize antigens does not depend on the existence of a specific major histocompatibility complex . MHC is a molecule on the surface of cells that presents antigens to white blood cells. MHC varies from individual to individual and is the basis of donor compatibility in transplantation. In contrast to T cells, T cells can recognize antigens independently of MHC. This makes them a great candidate for the development of “off-the-shelf” that originate from donors rather than patients, and this approach can make treatment faster and more economical.

    Recommended Reading: Can X Ray Show Prostate Cancer

    Parp: Prime Treatment Target For Prostate Cancer

    Over the past decade, olaparib and rucaparib have become important treatments for women with ovarian and breast cancer, in whom genetic alterations that affect DNA repair processes are common. Among the most frequent such alterations are those in the BRCA1 and BRCA2 genes.

    Its no accident that researchers have identified people who have alterations in BRCA genes as ideal candidates for treatment with PARP inhibitors.

    BRCA proteins and some PARP proteins are both integral components of cells response to DNA damage. If that response is already dysfunctional because of BRCA1 or BRCA2 mutations, then researchers reasoned that blocking the activity of PARP proteins could further hamper any chance of repairakin to punching a hole in a tire that already has a slow leak. If the cancer cells cant fix the DNA damage, they will die.

    Prostate cancer emerged as another strong candidate for PARP inhibitors after studies suggested that alterations in BRCA1 and BRCA2, as well as other genes involved in a cells ability to respond to DNA damage, may be present in approximately one-quarter of men with the disease. Other studies linked these genetic changes to an increased risk of prostate cancer, as well as more aggressive disease.

    Those findings, Dr. Karzai explained, led to a series of clinical trials of PARP inhibitors in men with metastatic prostate cancer, laying the foundation for the new FDA approvals.

    Fda Grants Orphan Drug Designation To Qn

    Research shows 98% cure rate for prostate cancer using Stereotactic ...

    The FDA has granted an orphan drug designation to QN-302 for the treatment of patients with pancreatic cancer.

    The FDA has granted an orphan drug designation to QN-302 for the treatment of patients with pancreatic cancer, according to an announcement from Qualigen Therapeutics.1,2

    Receiving orphan drug designation for our lead cancer therapeutic, QN-302, for treating pancreatic cancer, is an important accomplishment as we prepare to submit our investigational new drug application in the first half of 2023 for our phase 1 clinical trial. It is a testament of Qualigens commitment to developing treatments for devastating, rare cancers with unmet medical need, Michael Poirier, chairman and chief executive officer of Qualigen, said in a press release.

    QN-302 is a potentially first-in-class, small molecule selective transcription inhibitor with strong binding affinity to G-quadruplex , which is prevalent in cancer cells compared with normal cells. Through this binding, the agent may help stabilize G4 against unwinding, leading to decreased cancer cell proliferation.

    Preclinical in vitro and in vivo studies of QN-302 have shown that G4 stabilization may result in inhibition of target gene expression and inhibit cell growth in a variety of cancers, including prostate, sarcomas, gastrointestinal stromal tumors, and pancreatic ductal adenocarcinoma, which represents 98% of pancreatic cancers.

    Also Check: Psma Pet Scan Prostate Cancer

    New Drug Approved For Metastatic Prostate Cancer

    https://www.facingourrisk.org/XRAY/Pluvicto-Locametz-treatment-for-metastatic-prostate-cancer
    Full article: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pluvicto-metastatic-castration-resistant-prostate-cancer

    The FDA approved a new treatment for metastatic castration-resistant prostate cancer. They also approved a test that can be used to identify patients who would benefit from this new treatment.

    Just One Weapon Against Cancer

    Before treatment with PLUVICTOTM is recommended, patients undergo a to determine if their tumor contains the PSMA target. If it does not, PLUVICTOTM would not be appropriate, explained Dr. Wong. At Duke we treat you as an individual. Each case is discussed among a multidisciplinary team of surgeons, radiation oncologists, medical oncologists, radiologists, and nuclear medicine specialists. He emphasized that PLUVICTOTM is not for everyone and is just one weapon in the arsenal for fighting cancer. Our team will determine how and if this new option fits in with all the others we offer.

    Duke can provide PLUVICTOTM and other novel treatments because it is a Comprehensive Cancer Center with the latest advances in diagnosing and treating prostate cancer. Duke is also recognized as a Comprehensive Radiopharmaceutical Therapy Center of Excellence, which requires strict adherence to safety and treatment criteria that ensures the best care for patients.

    You May Like: Stages Of Prostate Cancer Explained

    Combination With Angiogenesis Inhibitors

    Angiogenesis inhibitors are being investigated in the clinical setting. Aflibercept is a fusion protein which binds all forms of vascular endothelial growth factor-A , VEGF-B and placental growth factor, with higher affinity than their native receptors. Aflibercept is being investigated in a randomized phase III, placebo-controlled study in combination with docetaxel and prednisone in patients with CRPC .

    A phase III randomized, double-blind, placebo- controlled study of tasquinimod, an oral second-generation quinoline-3-carboxamide anti- angiogenic drug, in asymptomatic to mildly symptomatic patients with metastatic CRPC, is investigating whether tasquinimod delays disease progression compared with placebo.

    Use In Specific Populations

    New FDA Approval: Darolutamide for Hormone-Sensitive Disease | Mark Scholz, MD | PCRI

    Men of reproductive potential should use effective contraception during apalutamide treatment and for 3 months after the last dose of apalutamide. The drug can cause harm to a fetus or loss of pregnancy. Men with a female partner with reproductive potential should use contraception. Apalutamide may increase the risk for impaired fertility in men of reproductive potential.8

    No overall differences in the effectiveness of apalutamide were reported in patients aged 65 years compared with younger patients.8

    You May Like: Md Anderson Prostate Cancer Doctors

    RELATED ARTICLES

    Most Popular