The FDA on April 12, 2019 granted accelerated approval to BALVERSA® (Erdafitinib) for patients with locally advanced or metastatic Urothelial Carcinoma, with susceptible FGFR3 or FGFR2 genetic alterations,that has progressed during or following Platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant Platinum-containing chemotherapy. Patients should be selected for therapy based on an FDA-approved companion diagnostic for BALVERSA®. The FDA also simultaneously approved the THERASCREEN® FGFR RGQ RT-PCR Kit, developed by QIAGEN, for use as a companion diagnostic for this therapeutic indication. BALVERSA® is a product of Janssen Pharmaceutical Companies.
Category: FDA Approvals
KEYTRUDA® (Pembrolizumab)
The FDA on April 11, 2019, approved KEYTRUDA® (Pembrolizumab) for the first-line treatment of patients with Stage III Non-Small Cell Lung Cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation, as well as those with metastatic NSCLC. Patients’ tumors must have no EGFR or ALK genomic aberrations and express PD-L1 (Tumor Proportion Score-TPS of 1% or more), as determined by an FDA-approved test. KEYTRUDA® was previously approved as a single agent for the first-line treatment of patients with metastatic NSCLC whose tumors express PD-L1 TPS of 50% or more. KEYTRUDA® is a product of Merck Inc.
TECENTRIQ® (Atezolizumab)
The FDA on March 18, 2019 approved TECENTRIQ® in combination with Carboplatin and Etoposide, for the first-line treatment of adult patients with Extensive-Stage Small Cell Lung Cancer (ES-SCLC). TECENTRIQ® is a product of Genentech Inc.
TECENTRIQ® (Atezolizumab)
The FDA on March 8, 2019 granted accelerated approval to TECENTRIQ® in combination with Paclitaxel protein-bound for adult patients with unresectable locally advanced or metastatic Triple Negative Breast Cancer (TNBC) whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells [IC] of any intensity covering 1% or more of the tumor area), as determined by an FDA-approved test. The FDA also approved the VENTANA PD-L1 (SP142) Assay as a companion diagnostic device for selecting TNBC patients for TECENTRIQ®. TECENTRIQ® is a product of Genentech Inc.
HERCEPTIN HYLECTA® (Trastuzumab and Hyaluronidase-oysk)
The FDA on February 28, 2019 approved HERCEPTIN HYLECTA®, a combination of HERCEPTIN® (Trastuzumab), a HER2/neu receptor antagonist, and Hyaluronidase, an endoglycosidase, for the treatment of HER2 overexpressing breast cancer. HERCEPTIN HYLECTA® is a product of Genentech Inc.
LONSURF® (Trifluridine/ Tipiracil)
The FDA on February 22, 2019 approved LONSURF® tablets, a fixed combination of Trifluridine, a nucleoside metabolic inhibitor, and Tipiracil, a thymidine phosphorylase inhibitor, for adult patients with metastatic Gastric or GastroEsophageal Junction (GEJ) adenocarcinoma, previously treated with at least two prior lines of chemotherapy that included a Fluoropyrimidine, a Platinum, either a Taxane or Irinotecan, and if appropriate, HER2/neu-targeted therapy. LONSURF® is a product of Taiho Pharmaceutical Co., Ltd.
KEYTRUDA® (Pembrolizumab)
The FDA on February 15, 2019 approved KEYTRUDA® for the adjuvant treatment of patients with Melanoma with involvement of lymph node(s) following complete resection. KEYTRUDA® is a product of Merck & Co., Inc.
CABLIVI® (Caplacizumab-yhdp)
The FDA on February 6, 2019 approved CABLIVI® for adult patients with acquired Thrombotic Thrombocytopenic Purpura (aTTP), in combination with Plasma Exchange and immunosuppressive therapy. CABLIVI® is a product of Ablynx NV.
ONTRUZANT® (Trastuzumab-dttb)
The FDA on January 18, 2019 granted approval to ONTRUZANT®, a Trastuzumab (HERCEPTIN®) biosimilar, for the treatment of patients with HER2-overexpressing Breast cancer or metastatic Gastric or GastroEsophageal Junction adenocarcinoma. The newly approved biosimilar will also eventually compete with 2 prior FDA approved biosimilars, OGIVRI® (Trastuzumab-dkst) and HERZUMA® (Trastuzumab-pkrb). ONTRUZANT® is a product of Samsung Bioepis and will be marketed by Merck&Co.
CABOMETYX® (Cabozantinib)
The FDA on January 14, 2019 approved CABOMETYX® for patients with HepatoCellular Carcinoma (HCC) who have been previously treated with NEXAVAR® (Sorafenib). CABOMETYX® is a product of Exelixis, Inc.