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The FDA on February 5, 2021 granted accelerated approval to UKONIQ®, a kinase inhibitor including PI3K-delta and casein kinase CK1-epsilon, for the following indications:
• Adult patients with Relapsed or Refractory Marginal Zone Lymphoma (MZL) who have received at least one prior anti-CD20-based regimen;
• Adult patients with Relapsed or Refractory Follicular Lymphoma (FL) who have received at least three prior lines of systemic therapy.
UKONIQ® is a product of TG Therapeutics Inc.
The FDA on February 3, 2021 granted accelerated approval to TEPMETKO® for adult patients with metastatic Non-Small Cell Lung Cancer (NSCLC) harboring Mesenchymal-Epithelial Transition (MET) exon 14 skipping alterations. TEPMETKO® is a product of EMD Serono Inc.
The FDA on January 22, 2021 approved the combination of OPDIVO® (Nivolumab) and CABOMETYX® (Cabozantinib) as first line treatment for patients with advanced Renal Cell Carcinoma (RCC). OPDIVO® is a product of Bristol-Myers Squibb Co. and CABOMETYX® is a product of Exelixis, Inc.
The FDA on January 15, 2021 granted accelerated approval to DARZALEX Faspro® in combination with Bortezomib, Cyclophosphamide and Dexamethasone for newly diagnosed light chain (AL) Amyloidosis. DARZALEX FASPRO® is a product of Janssen Biotech Inc.
The FDA on January 15, 2021 approved ENHERTU® for adult patients with locally advanced or metastatic HER2-positive Gastric or GastroEsophageal (GEJ) adenocarcinoma who have received a prior Trastuzumab-based regimen. ENHERTU® is a product of Daiichi Sankyo Company.
The FDA on January 14, 2021 approved XALKORI® for pediatric patients 1 year of age and older and young adults with Relapsed or Refractory, systemic Anaplastic Large Cell Lymphoma (ALCL) that is ALK-positive. The safety and efficacy of XALKORI® have not been established in older adults with Relapsed or Refractory, systemic ALK-positive ALCL. XALKORI® is a product of Pfizer Inc.
The FDA on December 18, 2020 approved TAGRISSO® for adjuvant therapy after tumor resection in patients with Non-Small Cell Lung Cancer (NSCLC) whose tumors have Epidermal Growth Factor Receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. TAGRISSO® is a product of AstraZeneca Pharmaceuticals LP.
The FDA on December 16, 2020 approved MARGENZA® in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. MARGENZA® is a product of MacroGenics, Inc.