Product Approvals and Launches

The FDA has approved axatilimab-csfr (Niktimvo) for treating adults and children with chronic graft-versus-host disease who have progressed on at least 2 prior treatments.

The FDA approved Sandoz’ Enzeevu, the fourth aflibercept biosimilar to be approved for Americans with age-related macular degeneration and other retinal eye diseases.

Today, the FDA issued a complete response letter (CRL) for midomafetamine capsules (MDMA) in combination with assisted therapy (MDMA-AT) for adults living with posttraumatic stress disorder (PTSD).

Arash Mostaghimi, MD, MPA, MPH, assistant professor of dermatology, director of the inpatient dermatology consult service, and codirector of the Complex Medical Dermatology Fellowship at Brigham & Women's Hospital, discusses the recent FDA approval of deuruxolitinib for the treatment of moderate to severe alopecia areata.

Vorasidenib becomes the first targeted therapy for grade 2 isocitrate dehydrogenase (IDH)–mutant glioma to receive FDA approval.

Afami-cel, sold as Tecelra by Adaptimmune, is the first gene therapy to be approved for the rare form of cancer and the first FDA-approved T-cell receptor gene therapy.

Daratumumab/hyaluronidase-fihj plus bortezomib, lenalidomide, and dexamethasone is now approved by the FDA to treat newly diagnosed multiple myeloma (MM) in patients eligible for autologous stem cell transplant.

The Shield blood test developed by Guardant has been approved by the FDA as a primary screening option for colorectal cancer, providing a more convenient method of screening.

The FDA has approved deuruxolitinib, an oral medication developed by Sun Pharma, as the first-line treatment for adults with moderate to severe alopecia areata.

The catheter-delivered implant uses the right ventricle to support the left, improving left ventricle ejection fraction and helping restore the heart’s normal shape.

The aflibercept 8 mg injection improves patient care by allowing longer intervals between treatments, explains Jose A. Martinez, MD, Austin Retina Associates.

Today, the FDA approved roflumilast cream 0.15% (Zorvye; Arcutis Biotherapeutics) for the treatment of mild to moderate atopic dermatitis in patients 6 years and older.

FoundationOne Liquid CDx can be used to identify niraparib and abiraterone acetate eligibility in patients with metastatic castration-resistant prostate cancer (mCRPC).

Donanemab-azbt is the first and only amyloid plaque-targeting therapy approved for adults with early symptomatic Alzheimer disease.

The FDA approved SH-105 (Tepylute) prediluted injectable treatment for breast and ovarian cancers. This innovative formulation eliminates the need for complex powder reconstitution, improving safety and patient care.

The FDA approved epcoritamab-bysp to treat adults with relapsed or refractory (R/R) follicular lymphoma after 2 or more lines of systemic therapy.

Today, the FDA approved ensifentrine (Ohtuvayre; Verona Pharma) for the maintenance treatment of moderate to severe chronic obstructive pulmonary disease (COPD) based on the successful phase 3 ENHANCE trials.

The FDA today approved efgartigimod alfa and hyaluronidase-qvfc for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP).

Adult patients who have KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC) can use adagrasib as a supplemental treatment.

Accelerated approval was originally granted in June 2023 for patients aged 4 to 5 years, indicating there was an unmet clinical need for a potentially life-saving treatment for the rare genetic muscle disorder.

The FDA approved pembrolizumab (Keytruda) plus carboplatin and paclitaxel, followed by single-agent pembrolizumab, in adult patients with primary advanced or recurrent endometrial carcinoma.

The FDA has approved durvalumab combined with carboplatin and paclitaxel, followed by single-agent durvalumab.

Bringing the bispecific T-cell engager into the frontline consolidation phase "redefines the standard of care" for patients with B-ALL, an investigator said.

Neurotrophic tyrosine receptor kinase (NTRK)–positive locally advanced or metastatic solid tumors can now be treated with the first FDA-approved treatment option.

Children aged 10 years and older with type 2 diabetes can now improve their glycemic control with a drug previously only approved for adults.

The approval brings a new treatment option to pediatric patients with polyarticular juvenile idiopathic arthritis, which is a form of arthritis affecting multiple joints at the same time.

The latest approval of lisocabtagene maraleucel (liso-cel) in mantle cell lymphoma provides another treatment option and continues the tremendous advances in treatment for patients, said Christopher Flowers, MD, of MD Anderson Cancer Center.

The FDA approved mRNA-1345, a Moderna vaccine for the treatment of respiratory syncytial virus (RSV). This single-dose vaccine offers protection against lower respiratory tract disease in adults over 60 years, with data suggesting long-term effectiveness.