The FDA on December 12, 2022, granted accelerated approval to KRAZATI® (Adagrasib), a RAS GTPase family inhibitor, for adult patients with KRAS G12C-mutated locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy. KRAZATI® is a product of Mirati Therapeutics, Inc.
Author: RR
TECENTRIQ® (Atezolizumab)
The FDA on December 9, 2022, approved TECENTRIQ® (Atezolizumab) for adult and pediatric patients 2 years of age and older with unresectable or metastatic Alveolar Soft Part Sarcoma (ASPS). TECENTRIQ® is a product of Genentech, Inc.
REZLIDHIA® (Olutasidenib)
The FDA on December 1, 2022, approved REZLIDHIA® (Olutasidenib) capsules for adult patients with Relapsed or Refractory Acute Myeloid Leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test. REZLIDHIA® is a product of Rigel Pharmaceuticals, Inc.
RYLAZE® (Asparaginase erwinia chrysanthemi recombinant-rywn)
The FDA on November 18, 2022, approved a new Monday-Wednesday-Friday dosing regimen for RYLAZE® (Asparaginase erwinia chrysanthemi recombinant-rywn). Under the new regimen, patients should receive 25 mg/m2 intramuscularly on Monday and Wednesday mornings, and 50 mg/m2 intramuscularly on Friday afternoon. It also is approved to be administered every 48 hours at a dose of 25 mg/m2 intramuscularly. RYLAZE® is a product of Jazz Pharmaceuticals.
ELAHERE® (Mirvetuximab soravtansine-gynx)
The FDA on November 14, 2022, granted accelerated approval to ELAHERE® (Mirvetuximab soravtansine-gynx) for adult patients with Folate Receptor alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. ELAHERE® is a Folate Receptor alpha directed antibody and microtubule inhibitor conjugate. Patients are selected for therapy based on an FDA-approved test. ELAHERE® is a product of ImmunoGen, Inc.
IMJUDO® (Tremelimumab)
The FDA on November 10, 2022, approved IMJUDO® (Tremelimumab) in combination with IMFINZI® (Durvalumab) and platinum-based chemotherapy for adult patients with metastatic Non-Small Cell Lung Cancer (NSCLC) with no sensitizing Epidermal Growth Factor Receptor (EGFR) mutation or Anaplastic Lymphoma Kinase (ALK) genomic tumor aberrations. Both IMJUDO® and IMFINZI® are products of AstraZeneca Pharmaceuticals.
ADCETRIS® (Brentuximab vedotin)
The FDA on November 10, 2022, approved ADCETRIS® (Brentuximab vedotin) in combination with Doxorubicin, Vincristine, Etoposide, Prednisone, and Cyclophosphamide for pediatric patients 2 years of age and older with previously untreated high risk classical Hodgkin lymphoma (cHL). This is the first pediatric approval for ADCETRIS®. ADCETRIS® is a product of Seagen, Inc.
LIBTAYO® (Cemiplimab-rwlc)
The FDA on November 8, 2022, approved LIBTAYO® (Cemiplimab-rwlc) in combination with platinum-based chemotherapy for adult patients with advanced Non-Small Cell Lung Cancer (NSCLC) with no EGFR, ALK, or ROS1 aberrations. LIBTAYO® is a product of Regeneron Pharmaceuticals, Inc.
TECVAYLI® (Teclistamab-cqyv)
The FDA on October 25, 2022, granted accelerated approval to TECVAYLI® (Teclistamab-cqyv), the first bispecific B-Cell Maturation Antigen (BCMA)-directed CD3 T-cell engager, for adult patients with Relapsed or Refractory Multiple Myeloma who have received at least four prior lines of therapy, including a Proteasome Inhibitor, an Immunomodulatory agent, and an anti-CD38 monoclonal antibody. TECVAYLI® is a product of Janssen Biotech, Inc.
IMJUDO® (Tremelimumab)
The FDA on October 21, 2022, approved IMJUDO® (Tremelimumab) in combination with IMFINZI® (Durvalumab) for adult patients with unresectable HepatoCellular Carcinoma (uHCC). IMJUDO® is a product of AstraZeneca Pharmaceuticals.