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.
Category: FDA Approvals
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.).
VERZENIO® (Abemaciclib)
The FDA on October 12, 2021, approved VERZENIO® (Abemaciclib) with endocrine therapy (Tamoxifen or an Aromatase Inhibitor) for adjuvant treatment of adult patients with Hormone Receptor (HR)-positive, Human Epidermal growth factor Receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence and a Ki-67 score ≥20%, as determined by an FDA approved test. This is the first CDK 4/6 inhibitor approved for adjuvant treatment of breast cancer. VERZENIO® is a product of Eli Lilly and Company.
FDA also approved the Ki-67 IHC MIB-1 pharmDx (Dako Omnis) assay, submitted by Agilent, Inc., as a companion diagnostic for selecting patients for this indication.
Public Human Genetic Variant Databases
The FDA on October 7, 2021, granted recognition to a partial listing of the Memorial Sloan Kettering Cancer Center’s Oncology Knowledge Base (OncoKB) as the first tumor mutation database to be included in the Public Human Genetic Variant Databases.
TECARTUS® (Brexucabtagene autoleucel)
The FDA on October 1, 2021, approved TECARTUS® (Brexucabtagene autoleucel) for adult patients with Relapsed or Refractory B-cell precursor Acute Lymphoblastic Leukemia (ALL). TECARTUS® is a product of Kite Pharma, Inc.