The US FDA has approved extended-release injection buprenorphine (Brixadi, Braeburn Inc) for the treatment of moderate to severe opioid use disorder (OUD). The medication comes in two formulations: a weekly and a monthly version. The adverse reactions include headache, constipation, nausea, injection-site erythema, injection-site pruritus, insomnia & UTI.
Atogepant is the first and only, oral calcitonin gene-related peptide (CGRP) receptor antagonist approved for migraine. Dose: 60 mg dose 1 OD in chronic migraine. 30 mg and 60 mg for prevention of episodic migraine.
The 2023 GOLD report contains numerous updates:
Chapter 1
► A new definition of COPD has been proposed (Page 5)
► A section on Chronic Bronchitis has been added (Page 13)
► A table has been added with Proposed Taxonomy (Etiotypes) for COPD (Table 1.1)
Chapter 2
► Additional information on screening for COPD and case-finding has been included (Page 36)
► Information on Imaging and Computed Tomography (CT) has been included (Page 43)
► A table with information on the Use of CT in Stable COPD has been added (Table 2.8)
Chapter 3
► Vaccination Recommendations for people with COPD have been updated in line with current guidance from the CDC (Page 54)
► Further information on therapeutic interventions to reduce COPD mortality has been added (Page 67)
► A table has been added with information on the Evidence Supporting a Reduction in Mortality with Pharmacotherapy and Non-pharmacotherapy in COPD Patients (Table 3.6)
► Issues Related to Inhaled Delivery have been addressed (Page 69)
► Information on the topic of Adherence to Inhaled COPD Medications has been included (Page 71)
► A section on Tele-rehabilitation has been added (Page 76) Page 2 of 16
► The section on Interventional & Surgical Therapies for COPD has been expanded (Page 82)
► A figure has been added giving an Overview of Current and Proposed Surgical and Bronchoscopic Interventions for People with COPD (Figure 3.2)
Chapter 4
► A section on the choice of inhaler device has been added (Page 112)
► A table has been added with information on Basic Principles for Appropriate Inhalation Device Choice (Table 4.5)
► The ABCD Assessment Tool has been revised to the ABE Assessment Tool to recognize the clinical relevance of exacerbations, independent of the level of symptoms (Page 115)
► The information and figures outlining Initial Pharmacological Treatment and Follow-up Pharmacological Treatment have been updated. In particular, the positioning of LABA+LAMA and of LABA+ICS has been changed (Page 115)
Chapter 5
► The topic of management of exacerbations has been expanded to include details of possible alternative causes
of symptoms
► A new definition of COPD Exacerbation and a new set of parameters to assess exacerbation severity at the point of care has been included (Page 134)
► A new paragraph and a new figure on the Classification of the Severity of COPD Exacerbations have been added (Figure 5.1)
► A new table on Diagnosis and Assessment has been added (Table 5.3)
Chapter 6
► The chapter on COPD and Co-morbidities has been updated with the latest evidence.
Chapter 7
► The chapter on COVID-19 and COPD has been updated with new references and the latest evidence.
The US FDA has approved dabrafenib with trametinib for children aged 1 year or older who need systemic treatment for low-grade gliomas that have a BRAF V600E mutation. Dabrafenib/trametinib is the first systemic therapy approved for frontline treatment of low-grade, BRAF-mutated pediatric gliomas, the FDA said. Dabrafenib was given orally twice daily, and trametinib was given orally once daily. Children in the chemotherapy arm received a 10-week induction course followed by eight 6-week maintenance cycles.
Adverse effects: pyrexia (66%), rash (54%), headache (40%), vomiting (38%), musculoskeletal pain (36%), fatigue (31%), dry skin (31%), diarrhea (30%), nausea (26%), epistaxis and other bleeding events (25%), abdominal pain (24%), and dermatitis acneiform (23%). The more common grade 3 or 4 laboratory abnormalities were decreased neutrophil count (20%) and increases in alanine aminotransferase (3.1%) and aspartate aminotransferase levels (3.1%).
The US FDA has approved efanesoctocog alfa (Altuviiio), a first-in-class, high-sustained factor VIII replacement therapy for adults and children with hemophilia A. The product is used once a week and is indicated for routine prophylaxis and on-demand treatment to control bleeding episodes, as well as to control bleeding during surgery (perioperative management).
The US FDA approved a new indication for sacituzumab govitecan for patients with unresectable, locally advanced or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer after endocrine-based therapy and at least two additional systemic therapies for metastatic disease.
Adverse events: decreased leukocyte count, decreased neutrophil count, decreased hemoglobin, decreased lymphocyte count, diarrhea, fatigue, nausea, alopecia, glucose elevation, constipation, and decreased albumin. Labeling for the agent carries a black box warning of severe or life-threatening neutropenia and severe diarrhea.
Dose: 10 mg/kg IV on days 1 and 8 of 21-day cycles until disease progression or unacceptable toxicity.
Sacituzumab govitecan was previously approved for unresectable, locally advanced or metastatic triple-negative breast cancer after two or more prior systemic therapies and locally advanced or metastatic urothelial cancer after platinum-based chemotherapy and either a PD-1 or PD-L1 inhibitor.
The US FDA approved pirtobrutinib (Jaypirca) for relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor. Pirtobrutinib is the first and only non-covalent BTK inhibitor.
Dose: 200 mg once-daily
Adverse reactions: Fatigue, musculoskeletal pain, diarrhea, edema, dyspnea, pneumonia, bruising, decreased neutrophil counts, lymphocyte counts, and platelet counts.
Two classes of drugs may be more effective than others for the treatment of gastroparesis, though the overall quality of evidence remains low to moderate and additional data are needed, according to a new report. Oral dopamine antagonists and tachykinin-1 antagonists appear superior to placebo. Only one drug, the dopamine antagonist metoclopramide, has US Food and Drug Administration approval for the treatment of gastroparesis (Gastroparesis is a chronic disorder which means delayed stomach emptying without a blockage).
The US FDA has approved mosunetuzumab-axgb (Lunsumio) for use in patients with relapsed or refractory follicular lymphoma who have received at least two previous systemic therapies. This is a first-in-class bispecific antibody that is designed to target CD20 on the surface of B cells and CD3 on the surface of T cells. This dual targeting activates and redirects a patient’s existing T cells to engage and eliminate target B cells by releasing cytotoxic proteins into the B cells. Mosunetuzumab-axgb is administered as an intravenous infusion for a fixed duration, which allows for time off therapy, and can be infused in OPD.
Lenacapavir is the first of a new class of drugs called capsid inhibitors to be FDA-approved for treating HIV-1. The drug blocks the HIV-1 virus protein shell and interferes with essential steps of the virus evolution. Lenacapavir is administered only twice annually, but it is also combined with other antiretrovirals. After the initial doses are completed — given both orally and via subcutaneous injection — the drug is administered by injection every 6 months. The injections and oral tablets of lenacapavir are estimated to cost $42,250 in the first year of treatment and then $39,000 annually in the subsequent years.
