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.
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.
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.
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.
The FDA on October 16, 2020, granted regular approval to VENCLEXTA® (Venetoclax) in combination with Azacitidine, Decitabine, or Low-Dose Cytarabine (LDAC), for newly diagnosed Acute Myeloid Leukemia (AML) in adults, 75 years or older, or who have comorbidities precluding intensive induction chemotherapy. VENCLEXTA® was initially granted accelerated approval for this indication in November 2018. VENCLEXTA® is a product of AbbVie Inc. and Genentech Inc.
The FDA on October 14, 2020 extended the approval of KEYTRUDA® (Pembrolizumab) for the following indications:
1) Adult patients with Relapsed or Refractory classical Hodgkin Lymphoma (cHL)
2) Pediatric patients with Refractory cHL, or cHL that has Relapsed after 2 or more lines of therapy.
KEYTRUDA® is a product of Merck Sharp & Dohme Corp.