The FDA on March 22, 2021 approved KEYTRUDA® in combination with Platinum and Fluoropyrimidine-based chemotherapy for patients with metastatic or locally advanced Esophageal or Gastroesophageal (GEJ) (tumors with epicenter 1 to 5 centimeters above the GastroEsophageal Junction) carcinoma, who are not candidates for surgical resection or definitive chemoradiation. KEYTRUDA® is a product of Merck Sharp & Dohme Corp.
Category: FDA Approvals
FOTIVDA® (Tivozanib)
The FDA on March 10, 2021 approved FOTIVDA®, a kinase inhibitor, for adult patients with Relapsed or Refractory advanced Renal Cell Carcinoma (RCC) following two or more prior systemic therapies. FOTIVDA® is a product of AVEO Pharmaceuticals, Inc.
YESCARTA® (Axicabtagene ciloleucel)
The FDA on March 5, 2021 granted accelerated approval to YESCARTA® for adult patients with Relapsed or Refractory Follicular Lymphoma (FL) after two or more lines of systemic therapy. YESCARTA® is a product of Kite Pharma, Inc.
PEPAXTO® (Melphalan flufenamide)
The FDA on February 26, 2021, granted accelerated approval to PEPAXTO® in combination with Dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one Proteasome Inhibitor, one immunomodulatory agent, and one CD-38 directed monoclonal antibody. PEPAXTO® is a product of Oncopeptides, Inc.
LIBTAYO® (Cemiplimab-rwlc)
The FDA on February 9, 2021 granted regular approval to LIBTAYO® for patients with Locally Advanced Basal Cell Carcinoma (laBCC) previously treated with a HedgeHog pathway Inhibitor (HHI) or for whom a HHI is not appropriate, and granted accelerated approval to LIBTAYO® for patients with metastatic BCC (mBCC) previously treated with a HHI or for whom a HHI is not appropriate. LIBTAYO® is a product of Regeneron Pharmaceuticals, Inc.
BREYANZI® (Lisocabtagene maraleucel)
The FDA on February 5, 2021 approved BREYANZI® for the treatment of adult patients with Relapsed or Refractory (R/R) Large B-Cell Lymphoma after two or more lines of systemic therapy, including Diffuse Large B-Cell Lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), High-Grade B-Cell Lymphoma, Primary Mediastinal Large B-Cell Lymphoma, and Follicular Lymphoma Grade 3B. BREYANZI® is a product of Juno Therapeutics, Inc.
UKONIQ® (Umbralisib)
The FDA on February 5, 2021 granted accelerated approval to UKONIQ®, a kinase inhibitor including PI3K-delta and casein kinase CK1-epsilon, for the following indications:
• Adult patients with Relapsed or Refractory Marginal Zone Lymphoma (MZL) who have received at least one prior anti-CD20-based regimen;
• Adult patients with Relapsed or Refractory Follicular Lymphoma (FL) who have received at least three prior lines of systemic therapy.
UKONIQ® is a product of TG Therapeutics Inc.
TEPMETKO® (Tepotinib)
The FDA on February 3, 2021 granted accelerated approval to TEPMETKO® for adult patients with metastatic Non-Small Cell Lung Cancer (NSCLC) harboring Mesenchymal-Epithelial Transition (MET) exon 14 skipping alterations. TEPMETKO® is a product of EMD Serono Inc.
OPDIVO® and CABOMETYX®
The FDA on January 22, 2021 approved the combination of OPDIVO® (Nivolumab) and CABOMETYX® (Cabozantinib) as first line treatment for patients with advanced Renal Cell Carcinoma (RCC). OPDIVO® is a product of Bristol-Myers Squibb Co. and CABOMETYX® is a product of Exelixis, Inc.