The FDA on April 5, 2022, granted accelerated approval to VIJOICE® for adult and pediatric patients two years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy. VIJOICE® is a product of Novartis Pharmaceuticals Corporation.
Category: FDA Approvals
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.
PLUVICTO® (Lutetium Lu 177 vipivotide tetraxetan)
The FDA on March 23, 2022, approved PLUVICTO® for the treatment of adult patients with Prostate-Specific Membrane Antigen (PSMA)-positive metastatic Castration-Resistant Prostate Cancer (mCRPC), who have been treated with Androgen Receptor (AR) pathway inhibition and taxane-based chemotherapy. PLUVICTO® is a product of Advanced Accelerator Applications USA, Inc., a Novartis company.
KEYTRUDA® (Pembrolizumab)
The FDA on March 21, 2022, approved KEYTRUDA® (Pembrolizumab) as a single agent, for patients with advanced endometrial carcinoma that is MicroSatellite Instability-High (MSI-H) or MisMatch Repair deficient (dMMR), as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting, and who are not candidates for curative surgery or radiation. KEYTRUDA® is a product of Merck & Co., Inc.
OPDUALAG® (Nivolumab and Relatlimab-rmbw)
The FDA on March 18, 2022, approved OPDUALAG® for adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. OPDUALAG® is a fixed-dose combination of the LAG-3-blocking antibody Relatlimab and the Programmed Death receptor-1 blocking antibody, Nivolumab. OPDUALAG® is a product of Bristol-Myers Squibb Company.
LYNPARZA® (Olaparib)
The FDA on March 11, 2022, approved LYNPARZA® for the adjuvant treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) Human Epidermal growth factor Receptor 2 (HER2)-negative high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Patients must be selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA®. LYNPARZA® is a product of AstraZeneca Pharmaceuticals, LP.
OPDIVO® (Nivolumab)
The FDA on March 4, 2022 approved OPDIVO® with platinum-doublet chemotherapy for adult patients with resectable Non-Small Cell Lung Cancer (NSCLC) in the neoadjuvant setting. OPDIVO® is a product of Bristol-Myers Squibb Company.
CARVYKTI® (Ciltacabtagene)
The FDA on February 28, 2022, approved CARVYKTI® for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a Proteasome Inhibitor (PI), an Immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody. CARVYKTI® is a product of Janssen Biotech, Inc.
ORENCIA® (Abatacept)
The FDA on December 15, 2021, approved ORENCIA® (Abatacept) for the prophylaxis of acute Graft Versus Host Disease (aGVHD), in combination with a Calcineurin Inhibitor (CNI) and Methotrexate (MTX), in adults and pediatric patients 2 years of age and older undergoing Hematopoietic Stem Cell Transplantation (HSCT) from a matched or 1 allele-mismatched unrelated donor. This is the first drug approved to prevent aGVHD. The application included use of Real World Data (RWD) in the determination of clinical effectiveness. RWD is clinical data routinely collected from a variety of sources, including registry data, to generate Real World Evidence (RWE). ORENCIA® (Abatacept) is a product of Bristol-Myers Squibb Company.