FDA Roundup: Drug Approvals From May 2024

FDA Approves Breyanzi to Treat Relapsed or Refractory Mantle Cell Lymphoma

FDA Roundup: Drug Approvals From May 2024 / Grandbrothers - stock.adobe.com

The FDA approved lisocabtagene maraleucel (Breyanzi; liso-cel) for the treatment of relapsed or refractory mantle cell lymphoma in adult patients who have received at least 2 lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor, Bristol Myers Squibb announced in a release. The therapy is now approved to treat 4 subtypes of non-Hodgkin lymphoma, including large B-cell lymphoma, relapsed or refractory follicular lymphoma, and relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

FDA Approves Onyda XR, First and Only Liquid Nonstimulant for ADHD

The FDA has approved clonidine hydrochloride (Onyda XR), a once-daily, extended release, oral suspension for treatment of ADHD in pediatric patients aged 6 years and older. Clonidine hydrochloride can be used either as a monotherapy or as an adjunctive therapy to an approved central nervous system stimulant.

Amgen Gains FDA Approval for First Interchangeable Biosimilar to Eculizumab

The FDA approved eculizumab-aeeb (Bkemv) from Amgen Inc as the first interchangeable biosimilar to eculizumab (Soliris) for the treatment of rare diseases paroxysmal nocturnal hemoblobinuria (PNH) and atypical hemolytic uremic syndrome.

FDA Approves Aflibercept (Eylea) Biosimilars, Yesafili and Opuviz

The FDA approved aflibercept-jbvf (Yesafili) and aflibercept-yszy (Opuviz), the first interchangeable biosimilars for aflibercept (Eylea). These medications are used to treat neovascular age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.

FDA Approves Tarlatamab-dlle for Extensive-Stage Small Cell Lung Cancer

The FDA granted accelerated approval to tarlatamab-dlle (Imdelltra) for the treatment of extensive-stage small cell lung cancer (SCLC) in adults with disease progression on or after platinum-based chemotherapy, Amgen announced in a news release. Tarlatamab-dlle is now the first and only approved DLL3-targeting bispecific T-cell engager therapy for the aggressive form of lung cancer.

FDA Approves Myhibbin for Prophylaxis of Organ Rejection in Adult, Pediatric Transplant Recipients

The FDA approved mycophenolate mofetil oral suspension (Myhibbin), an antimetabolite immunosuppressant indicated for prophylaxis of organ rejection in both adults and pediatric recipients (aged 3 months and older) of allogenic kidney, heart, or liver transplants, in combination with other immunosuppressant therapies.

FDA Approves Second Formulation of Humira Biosimilar Cyltezo

The FDA approved adalimumab-adbm (Cyltezo), Boehringer Ingelheim’s high-concentration, citrate-free, interchangeable Humira (adalimumab; AbbVie) biosimilar, to treat several chronic inflammatory diseases, the company announced in a release.

FDA Approves Updated Label for Altuviiio for Effective Bleed Protection in Children Younger than 12 Years

The FDA has approved an updated label for antihemophilic factor (recombinant), Fc-VWF-XTEN Fusion Protein-ehtl (Altuviiio), now including the full results of the phase 3 XTEND-Kids (NCT04759131) clinical trial which demonstrated the effectiveness of once-weekly Altuviiio in providing bleed protection in pediatric patients aged younger than 12 years with hemophilia A.

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