FDA Updates

Patients with urothelial carcinoma who were treated with the nivolumab-based regimen had better OS and PFS compared with those who received cisplatin with gemcitabine alone.

The application was previously granted fast track designation and orphan drug designation.

The designation is for all patients with low-grade serous ovarian cancer, regardless of their KRAS status and after 1 or more prior lines of therapy.

Tocilizumab-aazg (Tyenne; Fresenius Kabi) is the first approved biosimilar to tocilizumab (Actemra; Genentech) as both intravenous and subcutaneous.

They also compared the approach of the European Medicines Agency and the FDA in drug approvals.

The device conducts blood biomarker tests that accurately diagnose amyloid pathology and can assist in diagnosing Alzheimer disease in patients with cognitive impairment.

The continuous glucose monitoring system will be available for purchase online and without a prescription starting in summer 2024.

Denosumab-bbdz (Wyost; Sandoz) and denosumab-bbdz (Jubbonti; Sandoz) are approved as interchangeable for all indications of denosumab (Xgeva and Prolia; Amgen).

This designation makes CBL-514 the first drug to receive both Orphan Drug Designation and Fast Track Designation for the treatment of Dercum disease.

Juvéderm Voluma XC (AbbVie) is the first and only hyaluronic acid dermal filler to receive FDA approval for this indication with results lasting up to 13 months.

The FDA also granted traditional approval to amivantamab-vmjw for adults whose disease has progressed on or after platinum-based chemotherapy.

Hypomyelination with atrophy of the basal ganglia and cerebellum is the most severe form of TUBB4A leukodystrophy that currently has no curative treatment.

NVL-520 is a novel brain-penetrant ROS1-selective TKI being investigated for ROS1-positive metastatic non–small cell lung cancer in patients who have previously been treated with 2 or more ROS1 TKIs.

If approved, epcoritamab (DuoBody CD3xCD20; AbbVie, Genmab) would be the first and only subcutaneous bispecific antibody for treatment in this patient population.

The 3 bimekizumab indications include psoriatic arthritis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis.

For more than 30 years, there has been little treatment advancement for NMIBC patients. Fortunately, a new development in the treatment of NMIBC has been approved by the FDA and is now available.

The data follow the FDA approval of omalizumab for the reduction of allergic reactions, including anaphylaxis, that can occur after exposure to 1 or more foods.

The new indication includes individuals with HIV who have suppressed viral loads with known or suspected M184V/I resistance.

The sNDA was based on results from the KRYSTAL-1 study, evaluating the drug alone or in combination with other anti-cancer therapies in those with advanced solid tumors who have KRASG12C mutations.

The withdrawal comes after clinical trial results failed to demonstrate the safety and efficacy of melphalan flufenamide when combined with dexamethasone.

Adalimumab-ryvk is the first high-concentration, citrate-free biosimilar to Humira that has been granted interchangeability status for the 40 mg/0.4 ml injection.

Currently, the safety and efficacy of linvoseltamab in adult patients with relapsed or refractory multiple myeloma is being compared to elotuzumab, pomalidomide, and dexamethasone in a phase 3 clinical trial.

Currently, ocifisertib is being evaluated in a phase 1b and 2 trial to confirm the safety and tolerability profiles in patients with acute myeloid leukemia.

Teclistamab was previously approved in October 2022 for the treatment of adult patients with relapsed or refractory multiple myeloma who received at least 4 prior therapies.

Datopotamab deruxtecan is an investigational TROP2 directed antibody drug conjugate that showed positive survival impact compared to chemotherapy.

If vorasidenib receives full approval, it would be a first-in-class target therapy to treat individuals with IDH-mutant gliomas.

Osimertinib was previously approved as a monotherapy, the first-in-line global standard of care, for non–small cell lung cancer indications.

This marks the first and only time that an individualized T cell therapy has been approved by the FDA for a solid tumor cancer.