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.
Category: FDA Approvals
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.
RITUXAN® (Rituximab)
The FDA on December 2, 2021, approved RITUXAN® in combination with chemotherapy for pediatric patients (≥6 months to <18 years) with previously untreated, advanced stage, CD20-positive Diffuse Large B-Cell Lymphoma (DLBCL), Burkitt Lymphoma, Burkitt-Like Lymphoma, or mature B-cell Acute leukemia. RITUXAN® is a product of Genentech, Inc.
DARZALEX Faspro® (Daratumumab + hyaluronidase-fihj)
The FDA on November 30, 2021, approved DARZALEX Faspro® and KYPROLIS® (Carfilzomib) plus Dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy. DARZALEX Faspro® is a product of Janssen Biotech, Inc.
CYTALUX® (Pafolacianine)
The FDA on November 29, 2021, approved CYTALUX®, an optical imaging agent, for adult patients with ovarian cancer as an adjunct for interoperative identification of malignant lesions. CYTALUX® is a fluorescent drug that targets folate receptor which may be overexpressed in ovarian cancer. It is used with a Near-Infrared (NIR) fluorescence imaging system cleared by the FDA for specific use with CYTALUX®. CYTALUX® is a product of On Target Laboratories, LLC.
FYARRO® (Sirolimus protein-bound particles for injectable suspension-albumin-bound)
The FDA on November 22, 2021, approved FYARRO® for adult patients with locally advanced unresectable or metastatic malignant Perivascular Epithelioid Cell tumor (PEComa). FYARRO® is a product of Aadi Bioscience, Inc.