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.
Category: FDA Approvals
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.
KEYTRUDA® (Pembrolizumab)
The FDA on November 17, 2021, approved KEYTRUDA® (Pembrolizumab) for the adjuvant treatment of patients with Renal Cell Carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. KEYTRUDA® is a product of Merck & Co.
SCEMBLIX® (Asciminib)
The FDA on October 29, 2021, granted accelerated approval to SCEMBLIX® (Asciminib) for patients with Philadelphia chromosome-positive Chronic Myeloid Leukemia (Ph+ CML) in Chronic Phase (CP), previously treated with two or more Tyrosine Kinase Inhibitors (TKIs), and approved SCEMBLIX® for adult patients with Ph+ CML in CP with the T315I mutation. SCEMBLIX® is a product of Novartis AG.
TECENTRIQ® (Atezolizumab)
The FDA on October 15, 2021, approved TECENTRIQ® (Atezolizumab) for adjuvant treatment following resection and platinum-based chemotherapy in patients with Stage II to IIIA Non-Small Cell Lung Cancer (NSCLC) whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-approved test. TECENTRIQ® is a product of Genentech, Inc.
Today, the FDA also approved the VENTANA PD-L1 (SP263) Assay (Ventana Medical Systems, Inc.) as a companion diagnostic device to select patients with NSCLC for adjuvant treatment with TECENTRIQ®.
KEYTRUDA® (Pembrolizumab)
The FDA on October 13, 2021, approved KEYTRUDA® in combination with chemotherapy, with or without Bevacizumab, for patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1), as determined by an FDA-approved test. KEYTRUDA® is a product of Merck & Co., Inc.
FDA also granted regular approval to KEYTRUDA® as a single agent for patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. In June 2018, FDA had granted accelerated approval to this indication with the companion diagnostic, PD-L1 IHC 22C3 pharmDx (Dako North America Inc.).