LYNPARZA® (Olaparib)

January 2nd, 2020

The FDA on December 27, 2019 approved LYNPARZA® for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic pancreatic adenocarcinoma, as detected by an FDA-approved test, whose disease has not progressed on at least 16 weeks of a first-line Platinum-based chemotherapy regimen. The FDA also approved the BRACAnalysis CDx test (Myriad Genetic Laboratories, Inc.) as a companion diagnostic for the selection of patients with pancreatic cancer for treatment with LYNPARZA®, based upon the identification of deleterious or suspected deleterious germline mutations in BRCA1 or BRCA2 genes. LYNPARZA® is a product of AstraZeneca Pharmaceuticals LP.


ENHERTU® (fam-Trastuzumab deruxtecan-nxki)

December 27th, 2019

The FDA on December 20, 2019 granted accelerated approval to ENHERTU® for patients with unresectable or metastatic HER2-positive breast cancer, who have received two or more prior anti-HER2-based regimens in the metastatic setting. ENHERTU® is a product of Daiichi Sankyo.


PADCEV® (Enfortumab vedotin-ejfv)

December 27th, 2019

The FDA on December 18, 2019 granted accelerated approval to PADCEV® for adult patients with locally advanced or metastatic urothelial cancer who have previously received a Programmed Death receptor-1 (PD-1) or Programmed Death-Ligand 1 (PD-L1) inhibitor, and a Platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting. PADCEV® is a product of Astellas Pharma US, Inc.


XTANDI® (Enzalutamide)

December 27th, 2019

The FDA on December 16, 2019 approved XTANDI® for patients with metastatic Castration-Sensitive Prostate Cancer (mCSPC). XTANDI® is a product of Astellas Pharma Inc.


TECENTRIQ® (Atezolizumab)

December 27th, 2019

The FDA on December 3, 2019 approved TECENTRIQ® in combination with Paclitaxel protein-bound and Carboplatin for the first-line treatment of adult patients with metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations. TECENTRIQ® is a product of Genentech Inc.


REBLOZYL® (Luspatercept-aamt)

November 29th, 2019

The FDA on November 8, 2019 approved REBLOZYL® for treatment of anemia in adult patients with beta Thalassemia who require regular red blood cell transfusions. REBLOZYL® is a product of Celgene Corp.


BRUKINSA® (Zanubrutinib)

November 29th, 2019

The FDA on November 14, 2019 granted accelerated approval to BRUKINSA® for adult patients with Mantle Cell Lymphoma (MCL) who have received at least one prior therapy. BRUKINSA® is a product of BeiGene, Ltd.


ADAKVEO® (Crizanlizumab-tmca)

November 29th, 2019

The FDA on November 15, 2019 approved ADAKVEO® to reduce the frequency of Vaso-Occlusive Crises (VOCs) in adults and pediatric patients aged 16 years and older with Sickle Cell disease. ADAKVEO® is a product of Novartis Pharmaceuticals Corporation.


GIVLAARI® (Givosiran)

November 29th, 2019

The FDA on November 20, 2019 approved GIVLAARI® for adults with Acute Hepatic Porphyria (AHP). GIVLAARI® is a product of Alnylam Pharmaceuticals, Inc.


CALQUENCE® (Acalabrutinib)

November 29th, 2019

The FDA on November 21, 2019 approved CALQUENCE® for adults with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). CALQUENCE® is a product of AstraZeneca.