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.

VENCLEXTA® (Venetoclax)

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.

KEYTRUDA® (Pembrolizumab)

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.

OPDIVO® plus YERVOY®

The FDA on October 2, 2020 approved the combination of OPDIVO® (Nivolumab) plus YERVOY® (Ipilimumab) as first-line treatment for adult patients with unresectable Malignant Pleural Mesothelioma. Both OPDIVO® and YERVOY® are products of Bristol-Myers Squibb Co.