The FDA on May 8, 2020, expanded the indication of LYNPARZA® to include its combination with Bevacizumab for first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in Complete or Partial Response to first-line Platinum-based chemotherapy, and whose cancer is associated with Homologous Recombination Deficiency (HRD) positive status, defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability. LYNPARZA® is a product of AstraZeneca Pharmaceuticals, LP.
Category: FDA Approvals
RETEVMO® (Selpercatinib)
The FDA on May 8, 2020, granted accelerated approval to RETEVMO® for the following indications:
1) Adult patients with metastatic RET fusion-positive Non-Small Cell Lung Cancer (NSCLC).
2) Adult and pediatric patients 12 years of age or older with advanced or metastatic RET-mutant Medullary Thyroid Cancer (MTC) who require systemic therapy.
3) Adult and pediatric patients 12 years of age or older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy, and who are Radioactive Iodine-refractory (if Radioactive Iodine is appropriate).
RETEVMO® is a product of Eli Lilly and Company.
TABRECTA® (Capmatinib)
The FDA on May 6,2020 granted accelerated approval to TABRECTA® for adult patients with metastatic Non-Small Cell Lung Cancer (NSCLC) whose tumors have a mutation that leads to Mesenchymal-Epithelial Transition (MET) exon 14 skipping, as detected by an FDA-approved test. TABRECTA® is a product of Novartis.
DARZALEX FASPRO® (Daratumumab and Hyaluronidase-fihj)
The FDA on May 1, 2020 approved DARZALEX FASPRO® for adult patients with newly diagnosed or Relapsed/Refractory Multiple Myeloma. This new product allows for subcutaneous dosing of Daratumumab. DARZALEX FASPRO® is a product of Janssen Biotech, Inc.
TRODELVY® (Sacituzumab Govitecan-hziy)
The FDA on April 22, 2020, granted accelerated approval to TRODELVY®, for adult patients with metastatic triple-negative breast cancer, who received at least two prior therapies for metastatic disease. TRODELVY® is a product of Immunomedics, Inc.
IMBRUVICA® (Ibrutinib)
The FDA on April 21, 2020 expanded the indication of IMBRUVICA® to include its combination with RITUXAN® (Rituximab) for the initial treatment of adult patients with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). IMBRUVICA® is a product of Pharmacyclics LLC.
PEMAZYRE® (Pemigatinib)
The FDA on April 20, 2020, granted accelerated approval to PEMAZYRE® for the treatment of adults with previously treated, unresectable locally advanced or metastatic Cholangiocarcinoma with a Fibroblast Growth Factor Receptor 2 (FGFR2) fusion or other rearrangement, as detected by an FDA-approved test. PEMAZYRE® is a product of Incyte Corporation.
JELMYTO® (Mitomycin)
The FDA on April 15, 2020 approved JELMYTO® for adult patients with low-grade upper tract urothelial cancer. JELMYTO® is a product of UroGen Pharma.