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.
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.
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.
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.
The FDA on June 16, 2020 granted accelerated approval to KEYTRUDA® for the treatment of adult and pediatric patients with unresectable or metastatic Tumor Mutational Burden-High (TMB-H) [10 or more mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. KEYTRUDA® is a product of Merck & Co., Inc.