FDA Updates

Belimumab (Benlysta; GSK) is a B-lymphocyte stimulator-specific inhibiting monoclonal antibody.

Tarlatamab is a first-in-class immunotherapy that binds to DLL3 tumor cells and CD3 T-cells, to kill DLL3-expressing SCLC.

The indication is for adult patients who have received at least 2 prior lines of systemic therapy and is based on the response rate and duration of response shown in a phase 2 trial.

SNB-101 is the first nanoparticle anticancer drug that was developed exceedingly insoluble SN-38 into polymer nanoparticles.

Antihemophilic factor (recombinant) Fc-VWF-XTEN fusion protein-ehtl was initally approved in February 2023 for adults and children with hemophilia A for prophylaxis and on-demand treatment to control bleeding.

A provisional determination is also provided for the 40 mg/0.4 mL strength due to remaining interchangeability designation for another biosimilar to Humira.

This is the first approval of an EB virus-related mRNA therapeutic cancer vaccine and is a landmark achievement in future research on cancer treatment.

These developments highlight the dynamic landscape of health care innovation and the collaborative efforts driving progress in disease management and treatment.

The Rika system uses an individualized nomogram to help determine the plasma collection volume that is needed for each individual donor.

The new administration method, which is co-formulated with rHuPH20, is usable in previous approved nivolumab indications for solid tumors in adult patients.

Currently, the treatment is being evaluated in the phase 3 CALYPSO study to further prove the safety and efficacy in patients with hypoparathyroidism.

This citrate-free and high-dose approval of the biosimilar Humira provides another option to treat patients who are living with various inflammatory diseases.

The 1-time treatment may be a better alternative for patients who don’t want to undergo frequent doses of standard of care intravenous factor IX infusions.

Tisotumab vedotin-tftv is the first antibody-drug conjugate to demonstrate positive overall survival data in patients with previously treated recurrent or metastatic cancer.

Trastuzumab is indicated for adjuvant breast cancer, metastatic breast cancer, and gastric cancer.

The acceptance is based on positive data from the phase 3 ADORING 1 and ADORING 2 pivotal trials, as well as interim results from the phase 3 ADORING 3 open-label, long-term extension trial.

The indication is for patients aged 12 years of age and older, and the treatment is intended to increase the number of mature neutrophils and lymphocytes in patients.

Tovorafenib is the first systemic therapy to be approved for the treatment of pediatric patients who have low-grade glioma with BRAF rearrangements or fusions.

The approval is based on data from Study 5310, evaluating the pharmacokinetics, safety, and efficacy of Biktarvy (Gilead Sciences Inc) in pregnant individuals.

Dostarlimab plus chemotherapy is the only immuno-oncology-based therapy that showed statistically significant and clinically meaningful survival benefit in the overall patient population.

Naloxone hydrochloride (Amneal Pharmaceuticals Inc) is the generic equivalent to OTC Narcan (Emergent).

Pivmecillinam (Pivya; UTILITY therapeutics Ltd) tablets were approved for female adults with uncomplicated urinary tract infection caused by Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus.

This approval makes lutetium Lu177 the first therapy to be approved for the treatment of gastroenteropancreatic neuroendocrine tumors in pediatric patients.

The approval was based on the QUILT-3.032 study, which included 77 adults with carcinoma in situ with or without papillary tumors after a transurethral resection.

The primary endpoint of the study was clinical remission at week 52 with vedolizumab

With this approval, alectinib is the first anaplastic lymphoma kinase inhibitor to be approved for patients with ALK-positive, early-stage non-small cell lung cancer.

The product is currently being investigated alongside TLX101 in the IPAX-Linz and IPAX-2 clinical trials, and have previously shown efficacy in the IPAX-1 trial.

Ustekinumab (Stelara; Janssen Immunology) is a human monoclonal antibody that treats immune-mediated diseases such as psoriasis and psoriatic arthritis.