FDA granted accelerated approval to nivolumab (OPDIVO, Bristol-Myers Squibb Company) 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.
Attached is the draft guidance from FDA for biosimilars. There are several areas of concern from lumping all drugs under one HCPCS code, pricing issues, pharmacy substitution without notice, etc.
U.S. Food and Drug Administration is establishing the Oncology Center of Excellence (OCE) and appointing Dr. Richard Pazdur as its director. This will make oncology the first disease area to have a coordinated clinical review of drugs, biologics and devices across the agency’s three medical product centers.
Maybe you saw those words on a company’s website, or in a commercial promoting a new product or treatment. Some marketers may say their products are “FDA approved,” but how can you know for sure what the U.S. Food and Drug Administration approves?
U.S. Food and Drug Administration approved daratumumab (DARZALEX, Janssen Biotech, Inc.) in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.
FDA approved pembrolizumab (KEYTRUDA, Merck & Co., Inc.) 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. October 24, 2016.
FDA granted accelerated approval to olaratumab (LARTRUVO, Eli Lilly and Company) 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. October 19, 2016
On October 18, 2016, FDA approved atezolizumab (TECENTRIQ, Genentech Oncology) 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 atezolizumab.
FDA modified the indication for erlotinib (TARCEVA, Astellas Pharm Global Development Inc.) for treatment of non-small cell lung cancer (NSCLC) to limit use to patients whose tumors have specific epidermal growth factor receptor (EGFR) mutations. October 18, 2016.
FDA modified the dosage regimen for nivolumab (Opdivo, Bristol-Myers Squibb Co.) for the currently approved indications 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.
