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.
Category: FDA Approvals
ENHERTU® (fam-trastuzumab deruxtecan-nxki)
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.
XALKORI® (Crizotinib)
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.
TAGRISSO® (Osimertinib)
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.
MARGENZA® (Margetuximab-cmkb)
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.
GAVRETO® (Pralsetinib)
The FDA on December 1, 2020 approved GAVRETO®, for adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant Medullary Thyroid Cancer (MTC) who require systemic therapy, or RET fusion-positive thyroid cancer who require systemic therapy and who are Radioactive Iodine-refractory (if Radioactive Iodine is appropriate). GAVRETO® is a product of Blueprint Medicines Corporation.
DANYELZA® (Naxitamab)
The FDA on November 25, 2020 granted accelerated approval to DANYELZA® in combination with Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) for pediatric patients one year of age and older, and adult patients with relapsed or refractory high-risk Neuroblastoma in the bone or bone marrow, demonstrating a partial response, minor response, or stable disease to prior therapy. DANYELZA® is a product of Y-mAbs Therapeutics, Inc.
KEYTRUDA® (Pembrolizumab)
The FDA on November 13, 2020 granted accelerated approval to KEYTRUDA® in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic Triple-Negative Breast Cancer (TNBC) whose tumors express PD-L1 (CPS 10 or more), as determined by an FDA approved test. KEYTRUDA® is a product of Merck & Co.