Product Approvals and Launches

CMS has announced new federal rules that require health insurers to streamline requests to cover treatments; nearly 50,000 veterans used the emergency suicide prevention program launched by the Department of Veteran Affairs in 2023; the FDA recently authorized the first artificial intelligence (AI)-powered medical device to help doctors detect the most common forms of skin cancer.

The FDA and the European Medicines Agency have accepted marketing authorization applications and decisions are pending.

Bio-Thera Solutions’ Avzivi (bevacizumab-tnjn) has become the fifth biosimilar referencing Avastin (bevacizumab) to be approved in the United States.

The human monoclonal antibody known as tralokinumab-ldrm was tested and approved as a safe, effective treatment for pediatric patients with atopic dermatitis aged 12 to 17 years old.

In the phase 3 EV-302/KEYNOTE-A39 clinical trial, the antibody-drug conjugate enfortumab vedotin plus PD-1 inhibitor pembrolizumab nearly doubled both median overall survival and progression-free survival compared with chemotherapy.

The approval of belzutifan, an oral hypoxia-inducible factor-2 alpha inhibitor, provides a new option for patients with advanced renal cell carcinoma (RCC) following treatment with a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI).

Colin Howden, MD, discusses the mechanisms at work in vonoprazan as well as patient monitoring and potential future uses following a recent FDA approval for the treatment of erosive esophagitis.

The decision was supported by efficacy data from 36 patients from the ongoing phase 1/2 HGB-206 trial (NCT02140554) and 2 patients in the phase 3 HGB-210 trial (NCT04293185). It was the second approval from FDA for a gene therapy for sickle cell disease.

The FDA has approved a gene-editing therapy for sickle cell disease (SCD) for the first time.

Iptacopan, the first oral monotherapy for patients with paroxysmal nocturnal hemoglobinuria (PNH), is now an FDA-approved option for improving hemoglobin levels.

The therapy is already approved for certain patients with relapsed/refractory mantle cell lymphoma.

Desmoid tumors are noncancerous growths that appear in connective tissue, most often on the arms, legs, and abdomen. Aggressive tumors must be treated with surgery, radiation, or chemotherapy to keep them from growing into nearby organs, which can make them life threatening. They can cause pain and disfigurement, and they can reduce functioning and quality of life.

The FDA has approved capivasertib plus fulvestrant for the treatment of patients with HR-positive, HER2-negative, locally advanced or metastatic breast cancer harboring 1 or more PIK3CA, AKT1, or PTEN alteration, following progression on at least 1 endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.

The FDA has approved pembrolizumab (Keytruda) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic, HER2-negative gastric or gastroesophageal junction adenocarcinoma.

Adzynma is the first product to be approved for the treatment of the rare blood disorder that has 90% mortality when left untreated.

Recor Medical announced the FDA approval of its Paradise Ultrasound Renal Denervation system for the treatment of hypertension on November 7, 2023.

Tirzepatide is already approved to treat type 2 diabetes, and is now approved for chronic weight management in adults with obesity or overweight with at least 1 weight-related condition.

Phathom Pharmaceuticals' vonoprazan (Voquenza) sets a new standard in erosive gastroesophageal reflux disease (GERD) therapy.

The drug’s mode of action is different than other types of corticosteroids because it’s based on the differential effects on glucocorticoid and mineralocorticoid receptors.

Wezlana is the first biosimilar to reference Stelara approved in the United States. The product will launch in 2025.

The approval, which is based on results from the phase 3 KEYNOTE-966 trial, marks the sixth indication for pembrolizumab in gastrointestinal cancer.

The approval of secukinumab is the second approved biologic to treat hidradenitis suppurativa.

Bosutinib has a new indication in leukemia as a well as a newly-approved formulation.

Ivosidenib monotherapy is now approved by the FDA for patients with relapsed/refractory myelodysplastic syndrome with an IDH1 mutation.

With the approval, zilucoplan becomes the first once-daily subcutaneous complement C5 inhibitor available for adults with generalized myasthenia gravis.

Eric Donnenfeld, MD, from Ophthalmic Consultants of Long Island, discusses the importance of the Xdemvy FDA approval in treating patients with Demodex blepharitis.

The anti–PD-1 agent pembrolizumab was granted a new indication to treat patients with resectable non–small cell lung cancer (NSCLC) as a neoadjuvant treatment with chemotherapy and continued as adjuvant treatment after surgery.

School nurses play an overworked and understaffed role; Merck's immunotherapy Keytruda (pembroilzumab) has been granted approval for pre- and postsurgical treatment in lung cancer; the FDA is helping to curb tobacco-related health disparities.