Drug |
Pharmacologic Class |
Indication |
More Information |
| Endocrine Disorders | |||
| Tzield (teplizumab-mzwv) | Anti-CD3 monoclonal antibody | To delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years of age and older who have stage 2 type 1 diabetes. | Tzield Approved to Delay Onset of Stage 3 Type 1 Diabetes |
| Hematologic Disorders | |||
| Hemgenix (etranacogene dezaparvovec-drlb) | An adeno-associated virus vector-based gene therapy | Treatment of hemophila B (congenital factor IX deficiency). | First Gene Therapy for Hemophilia B Gets FDA Approval |
| Infectious Disease | |||
| Rebyota (fecal microbiota, live-jslm) | Fecal microbiota suspension | For the prevention of recurrence of Clostridioides difficile infection (CDI) in patients 18 years of age and older following antibiotic treatment for recurrent CDI. | Rebyota Approved to Prevent Recurrence of Clostridioides difficile Infection |
| Vemlidy (tenofovir alafenamide) | HBV nucleoside analog reverse transcriptase inhibitor | Treatment of chronic hepatitis B virus infection in pediatric patients 12 years of age and older with compensated liver disease. | Vemlidy Approved for Pediatric Patients With Chronic HBV Infection |
| Neurologic Disorders | |||
| Sezaby (phenobarbital sodium powder for injection) | Barbiturate | For the treatment of neonatal seizures in term and preterm infants. | Sezaby Approved to Treat Seizures in Term and Preterm Infants |
| Oncology | |||
| Adcetris (brentuximab vedotin) | CD30-directed antibody-drug conjugate | Treatment of pediatric patients 2 years and older with previously untreated high risk classical Hodgkin lymphoma, in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide.. | Adcetris Approved for Pediatric Patients With High Risk Classical Hodgkin Lymphoma |
| Elahere (mirvetuximab soravtansine-gynx) | Folate receptor alpha (FRα)-directed antibody and microtubule inhibitor | Treatment of adult patients with folate receptor alpha positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received 1 to 3 prior systemic treatment regimens. | Elahere Granted Accelerated Approval for Platinum-Resistant Ovarian Cancer |
| Imjudo (tremelimumab-actl) | Cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) blocking antibody | In combination with durvalumab and platinum-based chemotherapy for the treatment of adults with metastatic non-small cell lung cancer with no sensitizing epidermal growth factor receptor mutations or anaplastic lymphoma kinase genomic tumor aberrations. | Imjudo Plus Imfinzi and Chemotherapy Approved for Metastatic NSCLC |
| Libtayo (cemiplimab-rwlc) | Programmed death receptor-1 blocking antibody | First-line treatment of adults with non-small cell lung cancer with no EGFR, ALK or ROS1 aberrations. | Libtayo Drug Monograph |
| Tecvayli (teclistamab-cqyv) | Bispecific B-cell maturation antigen-directed CD3 T-cell engager | Treatment of adult patients with relapsed or refractory multiple myeloma, who previously received 4 or more prior lines of therapy, including a proteasome inhibitor, immunomodulatory drug and anti-CD38 monoclonal antibody. | Tecvayli Approved for Relapsed or Refractory Multiple Myeloma |
Publish Date
November 2022: Notable Drug Approvals
