Product Approvals and Launches

Approval for the T-cell–engaging bispecific antibody came today from the FDA.

Just over a year since AstraZeneca announced topline results, the FDA has approved a label expansion to include reducing cardiovascular (CV) death and heart failure–related hospitalizations for dapagliflozin (Farxiga) based on results of the phase 3 DELIVER trial.

A vaccine for adults 60 years and older was approved by the FDA for protection against respiratory syncytial virus, making it the first such vaccine to be approved worldwide.

The FDA has approved polatuzumab vedotin-piiq plus rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for certain patients with treatment-naive diffuse large B-cell lymphoma.

The FDA has granted accelerated approval to enfortumab vedotin-ejfv plus pembrolizumab for patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy.

Data from the PANORAMA-HF and PARADIGM-HF trials support the recommendation for approval from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency.

The FDA has granted full approval to pembrolizumab for the treatment of some patients with unresectable or metastatic microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR) solid tumors that have progressed following previous treatment.

Both the high-concentration and low-concentration versions of adalimumab-adaz (Hyrimoz) injection will launch in July, along with a wave of other biosimilars to Humira (reference adalimumab).

The FDA approved the VENTANA PD-L1 assay for expanded use in patients with advanced non–small-cell lung cancer to help identify patients who may be candidates for treatment with cemiplimab.

The FDA approved an expanded indication for abemaciclib (Verzenio) in combination with endocrine therapy for the adjuvant treatment of adult patients with hormone receptor (HR)–positive, HER2-negative, node-positive, early breast cancer that is at a high risk of recurrence.

Pegcetacoplan was approved by the FDA to treat geographic atrophy (GA), providing a treatment option for patients who previously had none, explained Eleonora Lad, MD, PhD, associate professor of ophthalmology, Duke University.

Efanesoctocog alfa is the first factor VIII therapy to overcome the interaction with endogenous von Willebrand factor, which creates a ceiling of 8 to 19 hours on the half-life of current factor VIII replacement products, which in turn creates the need for more frequent dosing.

Geographic atrophy is a leading cause of blindness. The new approval will help to fill an unmet need for patients.

Daprodustat (Jesduvroq, GSK) is the first oral hypoxia-inducible factor prolyl hydroxylase inhibitor to gain approval in the United States.

The approval is based on results from the phase 3 TROPiCS-02 trial demonstrating overall and progression survival benefits with sacituzumab govitecan compared with physician’s choice of single-agent chemotherapy.

The FDA has approved pirtobrutinib (Jaypirca) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma following at least 2 lines of systemic therapy, including a previous Bruton tyrosine kinase (BTK) inhibitor.

The FDA has approved elacestrant (Orserdu) for the treatment of postmenopausal women or adult men with estrogen receptor–positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least 1 line of endocrine therapy.

The broad approval, while expected, will likely signal a milestone in the treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).

The combination of tucatinib and trastuzumab received accelerated approval from the FDA to treat adults with RAS wild-type, HER2-positive unresectable or metastatic colorectal cancer (mCRC) that advances after treatment with specific types of chemotherapy.

Ublituximab-xiiy, developed by TG Therapeutics, will be sold under the name Briumvi.

The FDA’s approval of lecanemab for Alzheimer disease is very important, but there will remain significant challenges around pricing and access that will need to be addressed to deliver on the promise the therapy actually represents, said Alvaro Pascual-Leone, MD, PhD, of Harvard Medical School.

The lecanemab decision follows the controversial 2021 approval of aducanumab, which led to tight coverage restrictions for monoclonal antibodies directed against amyloid for the treatment of Alzheimer disease.

The approval makes mosunetuzumab the first in its class approved to treat follicular lymphoma and comes shortly after data from a phase 2 trial was presented at the annual meeting of the American Society of Hematology.

Jessica Allegretti, MD, MPH, medical director of the Crohn's and Colitis Center, Brigham and Women's Hospital, explained the mechanism of action for Rebyota, the first fecal transplant therapy approved by the FDA for the prevention of recurrent Clostridioides difficile infection (CDI) in individuals 18 years and older, following antibiotic treatment for recurrent CDI.

Ferring’s Rebyota, a novel first-in-class microbiota-based live biotherapeutic, has been approved by the FDA for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years and older, following antibiotic treatment for recurrent CDI.

The biologic is the first drug that aims to delay the diagnosis of type 1 diabetes.

In addition to the drug approval, the FDA approved a companion diagnostic to be used to identify patients who are eligible to receive the treatment.