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.
Category: FDA Approvals
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.
INQOVI® (Decitabine and Cedazuridine)
The FDA on July 7, 2020 approved INQOVI® for adult patients with MyeloDysplastic Syndromes (MDS) including the following:
1) Previously treated and untreated, de novo and secondary MDS with the following French-American-British subtypes (Refractory Anemia, Refractory Anemia with Ringed Sideroblasts, Refractory Anemia with excess blasts, and Chronic MyeloMonocytic Leukemia [CMML])
2) Intermediate-1, Intermediate-2, and high-risk International Prognostic Scoring System groups.
INQOVI® is a product of Astex Pharmaceuticals, Inc.
BAVENCIO® (Avelumab)
The FDA on June 30, 2020 approved BAVENCIO® for maintenance treatment of patients with locally advanced or metastatic Urothelial Carcinoma (UC) that has not progressed with first-line Platinum-containing chemotherapy. BAVENCIO® is a product of EMD Serono, Inc.
KEYTRUDA® (Pembrolizumab)
The FDA on June 29, 2020 approved KEYTRUDA® for the first-line treatment of patients with unresectable or metastatic MicroSatellite Instability-High (MSI-H) or MisMatch Repair deficient (dMMR) Colorectal cancer. KEYTRUDA® is a product of Merck & Co.
PHESGO®
The FDA on June 29, 2020 approved a new fixed dose combination of Pertuzumab, Trastuzumab, and Hyaluronidase–zzxf (PHESGO®) for the following indications:
A) Use in combination with chemotherapy as:
1) Neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer
2) Adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence.
B) Use in combination with Docetaxel for treatment of patients with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
PHESGO® is a product of Genentech, Inc.
KEYTRUDA® (Pembrolizumab)
The FDA on June 24, 2020 approved KEYTRUDA® for patients with recurrent or metastatic cutaneous Squamous Cell Carcinoma (cSCC) that is not curable by surgery or radiation. KEYTRUDA® is a product of Merck & Co., Inc.
XPOVIO® (Selinexor)
The FDA on June 22,2020 granted accelerated approval to XPOVIO® for adult patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL), Not Otherwise Specified, including DLBCL arising from Follicular Lymphoma, after at least 2 lines of systemic therapy. XPOVIO® is a product of Karyopharm Therapeutics.
TAZVERIK® (Tazemetostat)
The FDA on June 18, 2020 granted accelerated approval to TAZVERIK®, an EZH2 inhibitor, for adult patients with Relapsed or Refractory (R/R) Follicular Lymphoma (FL) whose tumors are positive for an EZH2 mutation, as detected by an FDA-approved test, and who have received at least 2 prior systemic therapies, and for adult patients with R/R FL who have no satisfactory alternative treatment options. TAZVERIK® is a product of Epizyme, Inc.