The FDA on February 2, 2017 granted accelerated approval to OPDIVO® for treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with a platinum-containing chemotherapy. OPDIVO® is marketed by Bristol-Myers Squibb company.
Category: FDA Approvals
RUBRACA® (Rucaparib)
The FDA on November 19, 2016 granted accelerated approval to RUBRACA® for treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer, who have been treated with two or more chemotherapies. RUBRACA® is a product of Clovis Oncology, Inc.
DARZALEX® (Daratumumab)
The FDA on November 21, 2016 approved DARZALEX® in combination with REVLIMID® (Lenalidomide) and Dexamethasone, or VELCADE® (Bortezomib) and Dexamethasone, for the treatment of patients with multiple myeloma, who have received at least one prior therapy. DARZALEX® is a product of Janssen Biotech, Inc.
OPDIVO® (Nivolumab)
The FDA on November 10, 2016 approved OPDIVO® for the treatment of patients with recurrent or metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN), with disease progression on or after a platinum-based therapy. OPDIVO® is marketed by Bristol-Myers Squibb company.
KEYTRUDA® (Pembrolizumab)
The FDA on October 24, 2016 approved KEYTRUDA® for the treatment of patients with metastatic Non Small Cell Lung Cancer (NSCLC), whose tumors express PD-L1, as determined by an FDA-approved test. This is the first FDA approval of a checkpoint inhibitor for first-line treatment of Lung cancer. This approval also expands the indication in second-line treatment of Lung cancer to include all patients with PD-L1-expressing NSCLC. KEYTRUDA® is a product of Merck & Co., Inc.
LARTRUVO® (Olaratumab)
The FDA on October 19, 2016 granted accelerated approval to LARTRUVO® for the treatment of patients with Soft Tissue Sarcoma (STS) not amenable to curative treatment with radiotherapy or surgery and with a histologic subtype for which an Anthracycline-containing regimen is appropriate. LARTRUVO® is a product of Eli Lilly and Company.
TECENTRIQ® (Atezolizumab)
The FDA on October 18, 2016 approved TECENTRIQ® for the treatment of patients with metastatic Non Small Cell Lung Cancer (NSCLC) whose disease progressed during or following Platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations, prior to receiving TECENTRIQ®. TECENTRIQ® is a product of Genentech, Inc.
TARCEVA® (Erlotinib)
The FDA on October 18, 2016 modified the indication for TARCEVA® for treatment of Non Small Cell Lung Cancer, to limit use to patients whose tumors have specific Epidermal Growth Factor Receptor (EGFR) mutations. TARCEVA® is a product of Astellas Pharm Global Development Inc.
OPDIVO® (Nivolumab)
The FDA on September 13, 2016 modified the dosage regimen for OPDIVO®, which is currently approved for Renal Cell Carcinoma, metastatic Melanoma, and Non Small Cell Lung Cancer. The currently approved recommended dosage regimens were modified to 240 mg intravenously (IV) every two weeks. OPDIVO® is marketed by Bristol-Myers Squibb company.
KEYTRUDA® (Pembrolizumab)
The FDA on August 5, 2016 granted accelerated approval to KEYTRUDA® injection for the treatment of patients with recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. KEYTRUDA® is a product of Merck Sharp & Dohme Corp.