The FDA on June 16, 2020 granted accelerated approval to KEYTRUDA® for the treatment of adult and pediatric patients with unresectable or metastatic Tumor Mutational Burden-High (TMB-H) [10 or more mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. KEYTRUDA® is a product of Merck & Co., Inc.
Category: FDA Approvals
ZEPZELCA® (Lurbinectedin)
The FDA on June 15, 2020 granted accelerated approval to ZEPZELCA® for adult patients with metastatic Small Cell Lung Cancer (SCLC), with disease progression on or after platinum-based chemotherapy. ZEPZELCA® is a product of Pharma Mar S.A.
OPDIVO® (Nivolumab)
The FDA on June 10, 2020 approved OPDIVO® for patients with unresectable, advanced, recurrent or metastatic Esophageal Squamous Cell Carcinoma (ESCC), after prior Fluoropyrimidine- and Platinum-based chemotherapy. OPDIVO® is a product of Bristol-Myers Squibb Co.
TECENTRIQ® (Atezolizumab) plus AVASTIN® (Bevacizumab)
The FDA on May 29, 2020 approved TECENTRIQ® in combination with AVASTIN® for patients with unresectable or metastatic Hepatocellular Carcinoma (HCC) who have not received prior systemic therapy. TECENTRIQ® and AVASTIN® are products of Genentech Inc.
OPDIVO® (Nivolumab) plus YERVOY® (Ipilimumab)
The FDA on May 26, 2020 approved the combination of OPDIVO® plus YERVOY® and 2 cycles of Platinum-doublet chemotherapy, as first-line treatment for patients with metastatic or recurrent Non-Small Cell Lung Cancer (NSCLC), with no Epidermal Growth Factor Receptor (EGFR) or Anaplastic Lymphoma Kinase (ALK) genomic tumor aberrations. OPDIVO® and YERVOY® are products of Bristol-Myers Squibb Co.
ALUNBRIG® (Brigatinib)
The FDA on May 22, 2020 approved ALUNBRIG® for adult patients with Anaplastic Lymphoma Kinase (ALK)-positive metastatic Non-Small Cell Lung Cancer (NSCLC), as detected by an FDA-approved test. ALUNBRIG® is a product of ARIAD Pharmaceuticals Inc.
LYNPARZA® (Olaparib)
The FDA on May 19, 2020 approved LYNPARZA® for adult patients with deleterious or suspected deleterious germline or somatic Homologous Recombination Repair (HRR) gene-mutated metastatic Castration-Resistant Prostate Cancer (mCRPC), who have progressed following prior treatment with Enzalutamide or Abiraterone. LYNPARZA® is a product of AstraZeneca Pharmaceuticals, LP.
TECENTRIQ® (Atezolizumab)
The FDA on May 18, 2020, approved TECENTRIQ® for the first-line treatment of adult patients with metastatic Non-Small Cell Lung Cancer (NSCLC) whose tumors have high PD-L1 expression (PD-L1 stained 50% or more of tumor cells [TC 50% or more] or PD-L1 stained Tumor-Infiltrating Immune Cells [IC] covering 10% or more of the tumor area [IC 10% or more]), with no EGFR or ALK genomic tumor aberrations. TECENTRIQ® is a product of Genentech Inc.
QINLOCK® (Ripretinib)
The FDA on May 15, 2020 approved QINLOCK® for adult patients with advanced GastroIntestinal Stromal Tumor (GIST), who have received prior treatment with 3 or more kinase inhibitors, including GLEEVEC® (Imatinib). QINLOCK® is a product of Deciphera Pharmaceuticals, LLC.