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A year in pharmacology: new drugs approved by the US food and drug administration in 2025.

The US Food and Drug Administration approved 45 new drugs and 4 new cellular and gene therapy products in 2025, that is, a total of 49 new medical therapies. Oncology, hematology/immunotherapy, and cardiovascular/respiratory drugs remain most frequent. Among oncology drugs, there is a trend for targeting ever smaller subtypes of malignancies and/or rarer malignancies. Trends over the past 6 years include steady levels of first-in-indication (about 10%), first-in-class (about 38%), and next-in-class (about 51%) approvals. Along with a large share of approvals in orphan indications (> 50%), fast

Denosumab versus zoledronic acid for primary osteoporosis: a 36-month retrospective cohort study on bone mineral density changes.

OBJECTIVE: To explore and compare the clinical efficacy and safety of denosumab versus zoledronic acid for the treatment of primary osteoporosis. METHODS: This retrospective cohort study included 413 primary osteoporosis patients (denosumab, n = 198; zoledronic acid, n = 215). All received daily calcium (600 mg) and vitamin D (400 IU), representing the total combined daily intake from diet and supplements. The denosumab group received subcutaneous denosumab 60 mg every 6 months and the zoledronic acid group annual intravenous zoledronic acid 5 mg over 36 months. Outcomes assessed at baseline

Advances in delivery methods of Arthrospira platensis (spirulina) for enhanced therapeutic outcomes.

Arthrospira platensis (A. platensis) aqueous extract has massive amounts of natural products that can be used as future drugs, such as C-phycocyanin, allophycocyanin, etc. This extract was chosen because of its high adaptability, which reflects its resolute genetic composition. The proactive roles of cyanobacteria, particularly in the medical field, have been discussed in this review, including the history, previous food and drug administration (FDA) reports, health benefits and the various dose-dependent therapeutic functions that A. platensis possesses, including its role in fighting against

Elranatamab in Japanese patients with relapsed/refractory multiple myeloma: results from MagnetisMM-2 and MagnetisMM-3.

BackgroundDespite advances, most patients with multiple myeloma (MM) experience relapse and repeat multiple treatment lines, highlighting an unmet need for patients with relapsed or refractory MM (RRMM). Bispecific antibodies are a new option, but their efficacy and safety in Japanese patients are unknown.MethodsThis was an analysis of Japanese patients receiving elranatamab monotherapy in MagnetisMM-2 (NCT04798586) and MagnetisMM-3 (NCT04649359). Both studies evaluated a priming dose regimen of elranatamab followed by weekly subcutaneous doses, in patients with disease progression while recei

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… CRS and ICANS were considered AEs of special interest, and infections, cytopenias, injection site reactions and secondary malignancies were considered AEs of clinical interest. … Injection site reactions were observed in 2 patients (50.0%), and none were grade 3/4. All 4 patients (100%) received anti-viral prophylaxis. Two patients (50.0%) received anti- Pneumonocystis jirovecii prophylaxis. …

Safety and efficacy of daratumumab in immune thrombocytopenia.

AbstractResistance to B-cell-targeted therapies in immune thrombocytopenia (ITP) has been linked to persistence of autoantibody-producing CD38+ long-lived plasma cells. CD38 antibody daratumumab has been proposed as a potential therapy for ITP. This multicenter, open-label, phase 2 study evaluated safety and efficacy of daratumumab in 21 patients with previously treated ITP. Following a safety run-in, 2 dosing cohorts received 8 and 10 subcutaneous injections of 1800 mg daratumumab weekly, respectively. Primary end points were safety and response (2 consecutive platelet counts ≥50 × 109/L at w

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… The most common treatment-related adverse events were infusion-related reactions (IRRs), occurring in 3 patients (14%), injection site reactions (9.5%), and diarrhea (9.5%). All IRRs were related to the first injection, and resolved within 24 hours. … site reaction 2 (9.5) 2 (9.5) 0 0 Erythematous rush 2 (9.5) 2 (9.5) 0 0 Injection site discoloration 1 (4.7) 1 (4.7) 0 0 Infections 1 (4.7) 1 (4.7) 1 (4.7) 0 Upper respiratory tract infections 1 (4.7) 0 1 (4.7) 0 Sinusitis 1 (4.7) 1 (4.7) 0 0 Diarrhea 2 (9.5) 0 2 (9.5) 0 Headache 1 (4.7) 1 (4.7) 0 0 …

Immunogenicity to biological drugs in psoriasis and psoriatic arthritis.

Monoclonal antibodies or fusion proteins, defined as biological drugs, have modified the natural history of numerous immune-mediated disorders, allowing the development of therapies aimed at blocking the pathophysiological pathways of the disease, providing greater efficacy and safety than conventional treatment strategies. Virtually all therapeutic proteins elicit an immune response, producing anti-drug antibodies (ADAs) against hypervariable regions of immunoglobulins. Immunogenicity against biological drugs can alter their pharmacokinetic and pharmacodynamic properties, thereby reducing the

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… The incidence of drug injection site reactions was 3% in patients with ADAs versus 1% in those without ADA development at weeks 16 and 5 versus 3% from week 52 onwards ( 79 ). CONCLUSIONS Currently, a variety of biological agents are available for the long-term treatment of PsO and PsA. …

Practical Considerations for the Daratumumab Management in Portuguese Routine Clinical Practice: Recommendations From an Expert Panel of Hematologists.

The recent therapeutic progress in multiple myeloma (MM) has led to the introduction of novel and highly potent drug classes. Daratumumab was the first CD38-targeting antibody showing to be effective and safe in MM patients as monotherapy and in combination regimens, which led to its rapid implementation in clinical practice. Considering that treatment discontinuation for drug-related adverse events can impact patients' quality of life and outcomes, the treatment decision should consider different factors and be weighted for each patient individually. Here, we aimed to guide clinicians using d

Molecular Inhibitors of Growth Signals

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Patient perspectives on symptoms, health-related quality of life, and treatment experience associated with relapsed/refractory multiple myeloma.

Abstract Purpose This study aimed to better understand the patient perspective and treatment experience of relapsed and/or refractory multiple myeloma (RRMM). Methods This qualitative study enrolled adult RRMM patients from 6 US clinics who had ≥ 3 months of life expectancy, ≤ 6 prior lines of therapy, and ≥ 1 treatment regimen with a proteasome inhibitor and immunomodulator, or a CD38 monoclonal antibody or an alkylating agent, and a steroid. In-person semi-structured qualitative interviews were conducted to capture concepts that were relevant and important to patients. Topics included RRMM s

Trifuhalol A Suppresses Allergic Inflammation through Dual Inhibition of TAK1 and MK2 Mediated by IgE and IL-33.

The activation and degranulation of immune cells play a pivotal role in allergic inflammation, a pathological condition that includes anaphylaxis, pruritus, and allergic march-related diseases. In this study, trifuhalol A, a phlorotannin isolated from Agarum cribrosum, inhibited the degranulation of immune cells and the biosynthesis of IL-33 and IgE in differentiated B cells and keratinocytes, respectively. Additionally, trifuhalol A suppressed the IL-33 and IgE-mediated activation of RBL-2H3 cells through the regulation of the TAK1 and MK2 pathways. Hence, the effect of trifuhalol A on allerg

Intratumorally injected pro-inflammatory allogeneic dendritic cells as immune enhancers: a first-in-human study in unfavourable risk patients with metastatic renal cell carcinoma.

BackgroundAccumulating pre-clinical data indicate that the efficient induction of antigen-specific cytotoxic CD8+ T cells characterizing viral infections is caused by cross-priming where initially infected DCs produce an unique set of inflammatory factors that recruit and activate non-infected bystander DCs. Our DC-based immunotherapy concept is guided by such bystander view and accordingly, we have developed a cellular adjuvant consisting of pre-activated allogeneic DCs producing high levels of DC-recruiting and DC-activating factors. This concept doesn't require MHC-compatibility between inj

Chinese expert consensus on the diagnosis and treatment of bone metastasis in lung cancer (2022 edition).

Lung cancer is the leading cause of cancer-related deaths worldwide. Bone is a common metastatic site of lung cancer, about 50% of bone metastatic patients will experience skeletal related events (SREs). SREs not only seriously impact the quality of life of patients, but also shorten their survival time. The treatment of bone metastasis requires multi-disciplinary therapy (MDT) and development of individualized treatment plan. In order to standardize the diagnosis and treatment of bone metastasis in lung cancer, the expert group of the MDT Committee of the Chinese Medical Doctor Association ha

Cancer Immunotherapies: What the Perioperative Physician Needs to Know.

Purpose of reviewFor patients with cancer, treatment may include combination therapy, including surgery and immunotherapy. Here, we review perioperative considerations for the patient prescribed immunotherapeutic agents.Recent findingsThe perioperative period is a poignant moment in the journey of a patient with cancer, potentially deemed most influential compared to other moments in the care continuum. Several immunotherapeutic medications have been employed near the time of surgery to potentially increase effectiveness. Of the various drug classes, including immune checkpoint inhibitors, cyt

Prospective observational study to evaluate the persistence of treatment with denosumab in patients with bone metastases from solid tumors in routine clinical practice: final analysis.

PURPOSE: In the integrated analysis of phase III head-to-head trials in patients with advanced solid tumors, denosumab demonstrated superiority over zoledronic acid in preventing skeletal-related events (SREs). Regular and continued drug use (persistence) is a precondition of clinical efficacy; persistence in real-life is yet undetermined for denosumab. METHODS: This was a single-arm, prospective, observational, non-interventional study in 598 patients with bone metastases from breast, prostate, lung, or other solid tumors treated with denosumab every four weeks in real-world clinical practic

Multiple Myeloma

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… Injection site reactions occurred and included discoloration, erythema, induration, and hematoma. Efficacy Regarding efficacy, at a 6.5-month follow-up the overall response rate was 52%, and median progression-free survival had not been reached. … IRRs and TEAEs were similar to those found in IV infusions of this medication, with the exception of injection site reactions. Going forward, SC daratumumab will be compared to IV daratumumab in a phase III non-inferiority study. …

Development and application of decatungstate catalyzed C-H 18F- and 19F-fluorination, fluoroalkylation and beyond.

Over the past few decades, photocatalytic C-H functionalization reactions have received increasing attention due to the often mild reaction conditions and complementary selectivities to conventional functionalization processes. Now, photocatalytic C-H functionalization is a widely employed tool, supporting activities ranging from complex molecule synthesis to late-stage structure-activity relationship studies. In this perspective, we will discuss our efforts in developing a photocatalytic decatungstate catalyzed C-H fluorination reaction as well as its practical application realized through co

A year in pharmacology: new drugs approved by the US Food and Drug Administration in 2021.

The second year of the COVID-19 pandemic had no adverse effect on the number of new drug approvals by the US Food and Drug Administration (FDA). Quite the contrary, with a total of 50 new drugs, 2021 belongs to the most successful FDA years. We assign these new drugs to one of three levels of innovation: (1) first drug against a condition ("first-in-indication"), (2) first drug using a novel molecular mechanism ("first-in-class"), and (3) "next-in-class", i.e., a drug using an already exploited molecular mechanism. We identify 21 first-in-class, 28 next-in-class, and only one first-in-indicati

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… Common AEs include injection site reaction, joint pain, urinary tract infection, diarrhea, bronchitis, pain in extremity, and dyspnea. … The most common AEs of vosoritide include injection site reactions, arthralgia, vomiting, and hypotension. …

Cancer Vaccines for Triple-Negative Breast Cancer: A Systematic Review.

Triple-negative breast cancer (TNBC) is the subtype of breast cancer with the poorest outcomes, and is associated with a high risk of relapse and metastasis. The treatment choices for this malignancy have been confined to conventional chemotherapeutic agents, due to a lack of expression of the canonical molecular targets. Immunotherapy has been recently changing the treatment paradigm for many types of tumors, and the approach of evoking active immune responses in the milieu of breast tumors through cancer vaccines has been introduced as one of the most novel immunotherapeutic approaches. Acco

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… The vaccine also proved to be safe with most AEs relating to injection site reactions, fevers, or grade 1/2 systemic AEs. … Regarding safety, all patients in the trial demonstrated grade 1/2, but not 3/4, injection site reactions. …

Advances in materials used for minimally invasive treatment of vertebral compression fractures.

Vertebral compression fractures are becoming increasingly common with aging of the population; minimally invasive materials play an essential role in treating these fractures. However, the unacceptable processing-performance relationships of materials and their poor osteoinductive performance have limited their clinical application. In this review, we describe the advances in materials used for minimally invasive treatment of vertebral compression fractures and enumerate the types of bone cement commonly used in current practice. We also discuss the limitations of the materials themselves, and

A Novel Intravesical Dextrose Injection Improves Lower Urinary Tract Symptoms on Interstitial Cystitis/Bladder Pain Syndrome.

Interstitial cystitis/bladder pain syndrome (IC/BPS) is a painful recurrent condition characterized by the discomfort of the bladder, and current treatment options have limited effectiveness. Prolotherapy is a well-known treatment that involves the injection of non-biologic solutions to reduce pain and/or promote proliferation of soft tissue, and dextrose is the most common injectate. This study investigated the effects of dextrose prolotherapy in a rat model of IC/BPS and patients with IC/BPS. We used cyclophosphamide to induce IC/BPS in rats, and intravesical instillation of 10% dextrose sol