The FDA on July 14, 2022, approved XALKORI® (Crizotinib) for adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory Inflammatory Anaplastic Lymphoma Kinase (ALK)-positive Myofibroblastic Tumors (IMT). XALKORI® (Crizotinib) is a product of Pfizer Inc.
Category: FDA Approvals
BREYANZI® (Lisocabtagene maraleucel)
The FDA on June 24, 2022, approved BREYANZI® (Lisocabtagene maraleucel) for adult patients with Large B-Cell Lymphoma (LBCL) who have refractory disease to first-line chemoimmunotherapy, or relapse within 12 months of first-line chemoimmunotherapy; or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for Hematopoietic Stem Cell Transplantation (HSCT) due to comorbidities or age. It is not indicated for the treatment of patients with primary Central Nervous System lymphoma. BREYANZI® is a product of Juno Therapeutics, Inc.
TAFINLAR® (Dabrafenib) and MEKINIST® (Trametinib)
The FDA on June 22, 2022, granted accelerated approval to TAFINLAR® (Dabrafenib) in combination with MEKINIST® (Trametinib) for the treatment of adult and pediatric patients 6 years of age or older with unresectable or metastatic solid tumors with BRAF V600E mutation, who have progressed following prior treatment, and have no satisfactory alternative treatment options. TAFINLAR® and MEKINIST® are products of Novartis Pharmaceuticals Corporation.
KYMRIAH® (Tisagenlecleucel)
The FDA on May 27, 2022, granted accelerated approval to KYMRIAH® (Tisagenlecleucel) for adult patients with Relapsed or Refractory Follicular Lymphoma (FL), after two or more lines of systemic therapy. KYMRIAH® is a product of Novartis Pharmaceuticals Corporation.
OPDIVO® (Nivolumab) and YERVOY® (Ipilimumab)
The FDA on May 27, 2022, approved the following for the first-line treatment of patients with advanced or metastatic Esophageal Squamous Cell Carcinoma (ESCC):
1) OPDIVO® (Nivolumab) in combination with Fluoropyrimidine and platinum-based chemotherapy
2) OPDIVO® in combination with YERVOY® (Ipilimumab) (Yervoy, Bristol-Myers Squibb Company)
OPDIVO® and YERVOY® are products of Bristol-Myers Squibb Company
TIBSOVO® (Ivosidenib)
The FDA on May 25, 2022, approved TIBSOVO® (Ivosidenib) in combination with Azacitidine (Azacitidine for injection) for newly diagnosed Acute Myeloid Leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test, in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. TIBSOVO® is a product of Servier Pharmaceuticals LLC.
ENHERTU® (fam-trastuzumab deruxtecan-nxki)
The FDA on May 4, 2022, approved ENHERTU® for adult patients with unresectable or metastatic HER2-positive breast cancer, who have received a prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within 6 months of completing therapy. ENHERTU® is a product of Daiichi Sankyo, Inc.
YESCARTA® (Axicabtagene ciloleucel)
The FDA on April 1, 2022, approved YESCARTA® for adult patients with Large B-Cell Lymphoma (LBCL) that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy. It is not indicated for the treatment of patients with primary Central Nervous System lymphoma. YESCARTA® is a product of Kite Pharma, Inc.