The FDA on September 27, 2018 approved VIZIMPRO® for the first-line treatment of patients with metastatic Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations, as detected by an FDA-approved test. VIZIMPRO® is aproduct of Pfizer Pharmaceutical Company.
Category: FDA Approvals
COPIKTRA® (Duvelisib)
The FDA on September 24, 2018 granted regular approval to COPIKTRA® for adult patients with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Llymphoma (SLL) after at least two prior therapies. In addition, COPIKTRA® received accelerated approval for adult patients with Relapsed or Refractory Follicular Lymphoma (FL) after at least two prior systemic therapies. COPIKTRA® is a product of Verastem, Inc.
COPIKTRA® (Duvelisib)
The FDA on September 24, 2018 granted regular approval to COPIKTRA® for adult patients with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Llymphoma (SLL) after at least two prior therapies. In addition, COPIKTRA® received accelerated approval for adult patients with Relapsed or Refractory Follicular Lymphoma (FL) after at least two prior systemic therapies. COPIKTRA® is a product of Verastem, Inc.
LUMOXITI® (Moxetumomab pasudotox-tdfk)
The FDA on September 13, 2018 approved LUMOXITI®, a CD22-directed cytotoxin indicated for adult patients with Relapsed or Refractory Hairy Cell Leukemia (HCL) who received at least two prior systemic therapies, including treatment with a Purine Nucleoside Analog (PNA). LUMOXITI® is a product of AstraZeneca Pharmaceuticals LP.
KEYTRUDA® (Pembrolizumab)
The FDA on August 20, 2018 approved KEYTRUDA® in combination with ALIMTA® (Pemetrexed) and Platinum as first-line treatment of patients with metastatic, Non-Squamous Non-Small Cell Lung Cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. KEYTRUDA® is a product of Merck & Co., Inc.
KEYTRUDA® (Pembrolizumab) and TECENTRIQ® (Atezolizumab)
The FDA on August 16, 2018 updated the prescribing information for these two agents, to require the use of an FDA-approved companion diagnostic test to determine PD-L1 levels in tumor tissue from patients with locally advanced or metastatic urothelial cancer who are Cisplatin-ineligible. FDA approved two different companion diagnostic tests, the Dako PD-L1 IHC 22C3 PharmDx Assay (Dako North America, Inc.) as a companion diagnostic for treatment with KEYTRUDA® and Ventana PD-L1 (SP142) Assay® (Ventana Medical Systems, Inc.) as a companion diagnostic test for treatment with TECENTRIQ®.
OPDIVO® (Nivolumab)
The FDA on August 16, 2018 granted accelerated approval to OPDIVO® for patients with metastatic Small Cell Lung Cancer (SCLC) with progression after platinum-based chemotherapy and at least one other line of therapy. OPDIVO® is a product of Bristol-Myers Squibb Company Inc.
LENVIMA® (Lenvatinib)
The FDA on August 16, 2018 approved LENVIMA® capsules for the first-line treatment of patients with unresectable HepatoCellular Carcinoma (HCC). LENVIMA® is a product of Eisai Inc.
POTELIGEO® (Mogamulizumab-kpkc)
The FDA on August 8, 2018 approved POTELIGEO® for adult patients with Relapsed or Refractory Mycosis Fungoides (MF) or Sézary Syndrome (SS) after at least one prior systemic therapy. POTELIGEO® is a product of Kyowa Kirin, Inc.
MULPLETA® (Lusutrombopag)
The FDA on July 31, 2018 approved MULPLETA® for thrombocytopenia in adults with Chronic Liver Disease (CLD) who are scheduled to undergo a medical or dental procedure. MULPLETA® is a product of Shionogi Inc.