Product Approvals and Launches

The FDA approved Amneal Pharmaceuticals' generic lenalidomide capsules, referencing Celgene's Revlimid, in multiple strengths.

The FDA approved Ospomyv and Xbryk, denosumab biosimilars that could expand access to treatment for osteoporosis, cancer-related bone loss, and other endocrine diseases.

The 5 mg risdiplam tablet provides the same efficacy and safety for spinal muscular atrophy as the currently available oral solution.

Adult and pediatric patients with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas that are not amenable to complete surgical resection are indicated in the approval.

Interim data from the ECHELON-3 trial previously showed that adding brentuximab vedotin to lenalidomide and rituximab improved overall survival among patients who have relapsed or refractory large B-cell lymphoma (R/R LBCL).

Jeffrey Stark, MD, vice president and head of medical immunology at UCB, discusses tailored dosing of bimekizumab-bkzx (Bimzelx) for various inflammatory conditions, highlighting its 5 FDA approvals and the remaining challenges.

Terra Wonsettler, PharmD, MBA, vice president of pharmacy for Evolent, discusses the recent HHS OIG report that stemmed from the 2021 FDA approval of aducanumab (Aduhelm) and use of the accelerated approval pathway.

Mikkael A. Sekeres, MD, Sylvester Comprehensive Cancer Center, discusses the potential benefits of treosulfan, a newly approved agent for allogeneic hematopoietic stem cell transplantation (allo-HSCT) conditioning in acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).

Mikkael A. Sekeres, MD, of Sylvester Comprehensive Cancer Center, University of Miami, discussed data supporting the FDA approval of treosulfan as part of conditioning for allogeneic hematopoeitic stem cell transplantation (allo-HSCT).

On October 14, 2024, the FDA approved a 320-mg single dose of bimekizumab-bkzx (Bimzelx; UCB) in a 2-mL prefilled syringe and autoinjector; both forms are now commercially available in the US.

The FDA has approved the first and only subcutaneous apomorphine infusion device, apomorphine hydrochloride injection (Onapgo), for the treatment of adults with advanced Parkinson disease.

The ranibizumab injection delivered through an implant device could be administered in a convenient schedule twice per year for the treatment of diabetic macular edema (DME).

Avtozma, the third biosimilar to Actemra, has received FDA approval for multiple inflammatory diseases and COVID-19, potentially expanding treatment access for patients.

Suzetrigine (Journavx) is the first new drug approved to treat acute pain in over 20 years and the first to be classified as a selective NaV1.8 pain signal inhibitor, an alternative to opiates.

Tovorafenib generated durable drug holiday responses in pediatric patients with BRAF-altered relapsed/refractory low-grade glioma.

The latest semaglutide (Ozempic; Novo Nordisk) approval is set to tackle a major need for patients with both type 2 diabetes (T2D) and chronic kidney disease (CKD), addressing their cardiovascular (CV) and kidney disease risks.

The FDA approved treosulfan in combination with fludarabine as preparation for allogeneic hematopoietic stem cell transplantation (allo-HSCT) in adult and pediatric patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).

Esketamine (Spravato; Johnson & Johnson) is now the first and only monotherapy for adults with major depressive disorder (MDD) with inadequate response to at least 2 oral antidepressants.

The Bruton tyrosine kinase inhibitor was approved in combination with bendamustine and rituximab in previously untreated mantle cell lymphoma (MCL) ineligible for autologous hematopoietic stem cell transplantation and as monotherapy in previously treated MCL.

The combination treatment specifically targets KRAS-mutated metastatic colorectal cancer (CRC) to improve progression-free survival.

Tislelizumab-jsgr (Tevimbra) was approved in combination with chemotherapy for the treatment of unresectable or metastatic HER2-negative (HER–) gastric or gastroesophageal junction adenocarcinoma (G/GEJ) in adults whose tumors express PD-L1.

In 2024, multiple drugs received complete response letters (CRLs), sometimes unrelated to the safety and efficacy of the drug, but patients with schizophrenia gained the first new treatment with a new mechanism of action in decades.

The approval of concizumab-mtci (Alhemo) injection marks a significant milestone in managing hemophilia A and B with inhibitors by preventing or reducing bleeding episodes in adults and children 12 years and older.

The approval marks the second for a generic in this class of medications indicated to improve glycemic control in patients with type 2 diabetes as a complement to diet and exercise.

The FDA issued a complete response letter for sotagliflozin (Zynquista) as an adjunct to insulin therapy for glycemic control.

Patients with the BRAF V600E mutation and metastatic colorectal cancer (CRC) can be treated with a combination of encorafenib with cetuximab and mFOLFOX6.

The FDA granted approval to Steqeyma (ustekinumab-stba) for inflammatory conditions, making it the seventh biosimilar to reference Stelara after a year of multiple ustekinumab biosimilar approvals.

The FDA has approved ensartinib in adult patients with anaplastic lymphoma kinase (ALK)–positive locally advanced or metastatic non–small cell lung cancer (NSCLC) naive to ALK treatment.

Subcutaneous amivantamab joins a growing list of drugs receiving complete response letters due to manufacturing facility issues.

The FDA has approved cosibelimab-ipdl for the treatment of adults with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or radiation.