The FDA on October 16, 2020, granted regular approval to VENCLEXTA® (Venetoclax) in combination with Azacitidine, Decitabine, or Low-Dose Cytarabine (LDAC), for newly diagnosed Acute Myeloid Leukemia (AML) in adults, 75 years or older, or who have comorbidities precluding intensive induction chemotherapy. VENCLEXTA® was initially granted accelerated approval for this indication in November 2018. VENCLEXTA® is a product of AbbVie Inc. and Genentech Inc.
Category: FDA Approvals
KEYTRUDA® (Pembrolizumab)
The FDA on October 14, 2020 extended the approval of KEYTRUDA® (Pembrolizumab) for the following indications:
1) Adult patients with Relapsed or Refractory classical Hodgkin Lymphoma (cHL)
2) Pediatric patients with Refractory cHL, or cHL that has Relapsed after 2 or more lines of therapy.
KEYTRUDA® is a product of Merck Sharp & Dohme Corp.
OPDIVO® plus YERVOY®
The FDA on October 2, 2020 approved the combination of OPDIVO® (Nivolumab) plus YERVOY® (Ipilimumab) as first-line treatment for adult patients with unresectable Malignant Pleural Mesothelioma. Both OPDIVO® and YERVOY® are products of Bristol-Myers Squibb Co.
GAVRETO® (Pralsetinib)
The FDA on September 4, 2020 granted accelerated approval to GAVRETO® for adult patients with metastatic RET fusion-positive Non-Small Cell Lung Cancer (NSCLC), as detected by an FDA approved test. GAVRETO® is a product of Blueprint Medicines Corporation.
ONUREG® (Azacitidine tablets)
The FDA on September 1, 2020, approved ONUREG® for continued treatment of patients with Acute Myeloid Leukemia who achieved first Complete Remission (CR) or Complete Remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy, and are not able to complete intensive curative therapy. ONUREG® is a product of Celgene Corporation.
KYPROLIS® and DARZALEX®
The FDA on August 20, 2020, approved KYPROLIS® (Carfilzomib) and DARZALEX® (Daratumumab) in combination with Dexamethasone for adult patients with Relapsed or Refractory multiple myeloma who have received one to three lines of therapy. KYPROLIS® is a product of Onyx Pharmaceuticals, Inc. DARZALEX® is a product of Janssen Biotech, Inc.
BLENREP® (Belantamab mafodotin-blmf)
The FDA on August 5, 2020 approved BLENREP® for adult patients with Relapsed or Refractory Multiple Myeloma who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a Proteasome Inhibitor, and an Immunomodulatory agent. BLENREP® is a product of GlaxoSmithKline.
MONJUVI® (Tafasitamab-cxix)
The FDA on July 31, 2020 granted accelerated approval to MONJUVI®, a CD19-directed cytolytic antibody, indicated in combination with REVLIMID® (Lenalidomide), for adult patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) Not Otherwise Specified (NOS), including DLBCL arising from Low grade lymphoma, and who are not eligible for Autologous Stem Cell Transplant. MONJUVI® is a product of MorphoSys US Inc.
TECENTRIQ®
The FDA on July 30, 2020 approved TECENTRIQ® (Atezolizumab) in combination with COTELLIC® (Cobimetinib) and ZELBORAF® (Vemurafenib) for patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. TECENTRIQ® along with COTELLIC® and ZELBORAF® are products of Genentech, Inc.
TECARTUS®
The FDA on July 24, 2020 granted accelerated approval to TECARTUS® (brexucabtagene autoleucel), a CD19-directed genetically modified Autologous T cell immunotherapy, for the treatment of adult patients with relapsed or refractory Mantle Cell Lymphoma (MCL). TECARTUS® is a product of Kite Pharma, a subsidiary of Gilead Sciences.